[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autism-spectrum-disorder-asd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autism-spectrum-disorder-asd":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,61,89,123,157,186,217,243,267,297,319,350,372,391,425,451,476,507,532,555,580,600,663,685,711],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100616348","phase-1-adia-med-of-winter-park-llc-autism-spectrum-disorder-research-study-100616348",false,"NCT07304440","Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study","Inclusion Criteria:\n\n* Age 3-12 years\n* Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2)\n* Parent\u002Fguardian willingness to consider experimental treatments and comply with study requirements\n* Ability to attend all scheduled visits\n* Able to meet study cost requirements ($12,000 study fee plus bloodwork costs, if applicable) as described in the informed consent\n\nExclusion Criteria:\n\n* Severe allergies to study products\n* Significant uncontrolled medical conditions\n* Pregnancy or breastfeeding (if applicable)\n* Participation in another interventional trial within 30 days\n* Prior stem cell or glutathione therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) or glutathione therapy (intravenous or topical) at any time prior to screening","ALL","3 Years","12 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This 24-month study is testing whether adding AdiaVita, an umbilical cord blood-derived stem cell and exosome product, to glutathione therapy helps improve autism symptoms in children ages 3-12 more than glutathione alone. Children will be randomly placed into one of two groups for the first three months: one group receives glutathione only, and the other receives glutathione plus monthly intravenous AdiaVita infusions. Both groups also use topical glutathione cream twice daily at home. Autism symptoms will be tracked over two years using the Autism Treatment Evaluation Checklist (ATEC) filled out by parents and by therapists or teachers. Safety, side effects, quality of life, and overall well-being will be closely monitored through regular clinic visits, physical exams, blood tests, and adverse event reporting. After the initial three-month phase, children who received glutathione alone may cross over to receive AdiaVita infusions at no additional cost if safety checks at month 6 are satisfactory. Approximately 100 children with a confirmed autism diagnosis from the Central Florida area will take part. Participation is completely voluntary, and families may withdraw at any time.",[28,29,30,31],"Autism Spectrum Disorder","Autism","ASD","Autism Spectrum Disorder (ASD)",[33,34,35,36,37,38,39,29,28,30,40,41,42,43,44,45,46,47],"Glutathione","Intravenous glutathione","Glutathione therapy","Antioxidant therapy","Oxidative stress","Immune modulation","Anti-inflammatory therapy","Autism symptoms","Stem cell therapy","MSCs","Mesenchymal stem cells","Regenerative medicine","Cellular therapy","Hematopoietic stem cells (HSCs)","Allogeneic stem cells","RECRUITING","2026-08-20",{"date":51,"type":52},"2026-08-21","ACTUAL",{"date":54,"type":52},"2026-05-01",{"date":56,"type":21},"2028-06-15",{"name":58,"class":59},"Adia Med of Winter Park LLC","OTHER",2,{"id":62,"slug":63,"hasResults":12,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":16,"minAge":69,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":76,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100614219","coaching-and-leadership-in-autism-support-settings-100614219","NCT07276750","Coaching and Leadership in Autism Support Settings","CLASS","Inclusion Criteria:\n\n* Special or general education teachers, paraeducators, and other staff who provide direct instruction and\u002For behavioral support to autistic children during the school day (e.g., speech therapist, school psychologist).\n* Autistic children with:\n* a documented autism spectrum disorder diagnosis via school records (i.e., Individualized Education Program; IEP)\n* are enrolled with a participating educator\n* are in grades K-5\n* ages 5-12\n* Sutter Eyberg Student Behavior Inventory-Revised (SESBI-R) total score \\>=101\n* EDI sum score of \\>=8 at baseline\n\nExclusion Criteria:\n\n* SESBI-R total score \\\u003C101 (i.e. T score 51+)\n* EDI sum score \\\u003C8",true,"5 Years",{"count":71,"type":21},373,[73],"NA","Schools serve a large number of autistic children, yet face two critical gaps that stifle the delivery of evidence-based practices: 1) an intervention gap characterized by limited availability of evidence-based practices educators can use to address externalizing behaviors when they occur in the classroom; and 2) an implementation gap consisting of insufficient evidence-based practice fidelity and sustainment over time. To address these gaps, this project proposes a hybrid type 2 effectiveness-implementation trial that simultaneously tests: 1) the clinical effectiveness of an efficient, educator-delivered clinical intervention to reduce autistic children's externalizing behaviors (Research Units in Behavioral Interventions in Educational Settings; RUBIES), and 2) the implementation effectiveness of an organizational implementation strategy designed specifically to enhance sustainment of evidence-based practices in public schools (Helping Educational Leaders Mobilize evidence; HELM). Consistent with the National Institute of Mental Health (NIMH)'s experimental therapeutics approach, the project also examines the mechanisms through which RUBIES impacts clinical outcomes and through which HELM influences implementation outcomes. The proposed study directly responds to high priority research areas of the US Department of Health and Human Services Interagency Autism Coordinating Committee's Strategic Plan for Autism Research, which calls for expanded research on the translation of proven-efficacious interventions into the community, NIMH Strategic Priority 3.3 to test interventions for effectiveness in community practice settings, and NIMH Strategic Priority 4.2 to expedite adoption, sustained implementation, and continuous improvement of evidence-based mental health services. If successful, this study will have substantial public health impact because it will produce an effective intervention for a prevalent problem among a high impact population in schools across the United States of America and will determine how to sustain this (and other) intervention(s) with high fidelity, to the betterment of health.",[31],[77,78,79,80],"implementation","schools","autism","behavior management",{"date":51,"type":52},{"date":83,"type":52},"2026-02-01",{"date":85,"type":21},"2030-08-31",{"name":87,"class":59},"University of California, Los Angeles",1,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":16,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":88},"100652105","assessing-outcomes-of-three-different-museum-based-social-prescription-programs-in-autistic-adults-100652105","NCT07768332","Assessing Outcomes of Three Different Museum-based Social Prescription Programs in Autistic Adults","Exploring the Feasibility of Social Prescription in People on the Autism Spectrum","Inclusion Criteria:\n\n* Meet the diagnostic criteria for autism spectrum disorder.\n* Have intellectual functioning within the normal range.\n* Be willing and able to participate in the study procedures.\n* Be willing to attend the relevant museum activities and group discussions, when applicable.\n* Agree to audio and video recording during relevant study activities.\n\nExclusion Criteria:\n\n* Are unwilling to complete the required assessments.\n* Have a serious physical or psychiatric condition that limits their physical stamina, emotional capacity, or ability to understand and complete the study procedures.\n* Refuse audio or video recording.","18 Years","50 Years",{"count":99,"type":21},90,[73],"This study will examine whether visiting the National Taiwan Museum can support the social and emotional well-being of autistic adults.\n\nThe research team plans to recruit 90 autistic adults aged 18 to 50 from the Department of Psychiatry at National Taiwan University Hospital. Participants must have average-range intellectual ability and be able and willing to complete the study activities and assessments. People with serious physical or mental health conditions that would prevent full participation will not be included. Participants must also agree to audio and video recording during the activities.\n\nAfter an outpatient doctor confirms eligibility, participants will complete questionnaires and choose one of three museum participation options:\n\n1. Visit the museum once independently.\n2. Join five guided museum visits with group discussions.\n3. Invite a friend to visit the museum together.\n\nEach group will include about 30 participants.\n\nFor the guided group, each session will last about 90 minutes and include a professional museum tour, a question-and-answer period, time for independent exploration, and a group discussion. Participants will be encouraged to select exhibits that interest them, record their observations, share their thoughts, listen to others, and respond to different viewpoints.\n\nThe five planned museum themes include Taiwan's history and identity, relationships between people and nature, architecture and living spaces, human evolution and the future, and attitudes toward money and financial planning. The discussions will explore everyday topics such as stereotypes, personal values, preferred living environments, hopes for the future, and managing money.\n\nParticipants will complete questionnaires before and after the program. These questionnaires will assess areas such as autistic characteristics, social communication, empathy, sensory experiences, comfort with social touch, emotional skills, loneliness, anxiety, depression, and anxiety during social interaction. Participants will also rate how enjoyable, comfortable, safe, interesting, and socially engaging they found the museum activities.\n\nThe researchers will compare participants' results before and after the program. They will also compare the three participation options to determine whether independent visits, guided group activities, or visiting with a friend produce different outcomes.\n\nThe overall goal is to understand whether museum-based activities can be used as a form of social prescribing to improve social participation, emotional well-being, confidence, and quality of life among autistic adults.",[103,29,104],"Autism Spectrum Disorder (ASD","Autistic Spectrum Disorder (ASD)",[106,30,79,107,108,109,110,111,112,113],"Autism spectrum disorder","psychosocial intervention","social participation","community-based intervention","cultural participation","autistic adults","social prescribing","museum-based intervention","2026-08-13",{"date":116,"type":52},"2026-08-17",{"date":118,"type":52},"2024-05-01",{"date":120,"type":21},"2027-12",{"name":122,"class":59},"National Taiwan University Hospital",{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":16,"minAge":96,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":88},"100651175","dance-yoga-and-mindful-movement-training-for-asd-100651175","NCT07758088","Dance, Yoga, And Mindful Movement Training For ASD","The Effects of a 12-week Program of Dance, Yoga, and Mindful Movement for Adults Aged 18-35 With Autism Spectrum Disorder","Inclusion Criteria:\n\n• Adults ages 18-36 with Level 1 and Level 2 Autism Spectrum Disorder.\n\nExclusion Criteria:\n\n• Adults ages 18-36 with Level 3 Autism Spectrum Disorder.","36 Years",{"count":132,"type":21},40,[73],"The goal of this study is to learn if a dance, yoga, and mindful movement program can improve the lives of adults with autism spectrum disorder (ASD). ASD is a condition that can affect how a person communicates, connects with others, and experiences daily life. This study focuses on adults ages 18 to 35.\n\nThe main questions it aims to answer are:\n\n* Can a dance, yoga, and mindful movement program improve social skills and communication for adults with ASD?\n* Can it improve their quality of life and sense of well-being?\n* Can it improve their physical, mental, and emotional health? Dance, yoga, and mindful movement have been studied in children with ASD, but very little research has looked at how they may help adults. This study hopes to help fill that gap.\n\nParticipants will:\n\n* Take part in a 12-week dance, yoga, and mindful movement program\n* Answer survey questions at the start and end of the program about their social skills, communication, quality of life, well-being, and overall health",[28,31,29],[29,137,138,139,140,141,142,143,144,145,146],"Autistic adults","Neurodiversity","Neurodivergent","Dance","Yoga","Mindful","Social communication","Well-being","Lifestyle intervention","Adaptive movement","NOT_YET_RECRUITING","2026-08-10",{"date":150,"type":52},"2026-08-12",{"date":152,"type":21},"2027-01-17",{"date":154,"type":21},"2027-04-04",{"name":156,"class":59},"USC Glorya Kaufman School of Dance",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":16,"minAge":69,"maxAge":97,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":60},"100629047","characterization-of-the-natural-history-of-microduplication-syndrome-7q1123-100629047","NCT07469566","Characterization of the Natural History of Microduplication Syndrome 7q11.23","Characterization of the Natural History of Microduplication Syndrome","HINADU7","Inclusion Criteria:\n\n* Diagnosis of 7q11.23 microduplication confirmed by Chromosomal Microarray Analysis or qPCR.\n* Aged \\> 5 to \\\u003C 50 years\n* Whose maternal language is French\n* Having signed the informed consent and\u002For for whom parents\u002Flegal guardian have signed the informed consent.\n* Affiliated to national Health Insurance system (sécurité sociale) or parents\u002Flegal guardian affiliated to national health insurance system Each 7DUP patient will be matched to a sex- and chronological age-matched control. Data from controls will come from the CREAT\\_criteria study (NCT 06018519). Each 7DUP patient will be matched to a sex- and mental age-matched control. Data from controls will come from the CREAT\\_criteria study (NCT 06018519).\n\nExclusion Criteria:\n\n* Refusal of the subject and\u002For the subject's parents\u002Flegal guardian to sign the informed consent\n* Refusal of the subject and\u002For the subject's parents\u002Flegal guardian to be informed of possible abnormalities detected during the neuropsychological assessment.\n\nRegarding specifically the neuroimaging data (MRI):\n\n* Having a contraindication to the MRI examination (people using a pacemaker or an insulin pump, people wearing a metal prosthesis or an intracerebral clip, and claustrophobic subjects).\n* Refusal of the subject and\u002For the subject's parents\u002Flegal guardian to be informed of possible abnormalities detected by MRI.",{"count":166,"type":21},15,[73],"7q11.23 duplication syndrome (7q duplication syndrome\u002F7DUP) is caused by a microduplication of the 7q11.23 chromosomal region, encompassing 26-28 genes, including the GTF2I gene. This syndrome, often considered as a \"mirror\" phenotype of Williams-Beuren syndrome (WBS), is characterized by a wide range of neurodevelopmental impairments, including a neurodevelopmental disorder (NDD), autism spectrum disorders (ASD), selective mutism, mild dysmorphic features, and aortic dilation. Notably, one of the core clinical features of 7DUP is socialization impairment, which varies in severity across individuals.\n\nThe GTF2I gene, identified as critical in the pathogenesis of both WBS and 7DUP, exhibits opposite expression patterns in the two syndromes, with reduced expression in WBS and overexpression in 7DUP. The gene's dysregulation in 7DUP plays a pivotal role in the pathogenesis of the associated NDD and social deficits. Despite progress in characterizing the genetic underpinnings of 7DUP, there remains a critical gap in understanding the developmental trajectory of socialization impairments in affected individuals, especially during their transition through different developmental stages, from early childhood to adulthood.\n\nRecent advancements in the study of neuronal models derived from induced pluripotent stem cells (iPSCs) and brain organoids have shed light on the molecular mechanisms driving 7DUP-related NDDs. Histone deacetylase inhibitors (HDAC inhibitors), which have been widely used in oncology, have shown promising preliminary results in reducing abnormal GTF2I expression in glutamatergic neurons differentiated from 7DUP patient-derived iPSCs. Preclinical studies in mouse models further demonstrated that these drugs can ameliorate socialization deficits, highlighting their therapeutic potential in addressing the core neurodevelopmental challenges in 7DUP.\n\nHowever, despite these advancements, no longitudinal clinical studies have characterized the developmental trajectory of socialization impairments in 7DUP patients. Understanding this trajectory is critical, as it can inform the timing and potential impact of therapeutic interventions, such as HDAC inhibitors. Given the complexity and variability of the 7DUP phenotype, a comprehensive clinical characterization of socialization impairments across the lifespan is essential to improve diagnostic accuracy, optimize intervention strategies, and ultimately improve patient outcomes.\n\nThe aim of this research is to characterize the developmental trajectory of socialization impairments in patients with 7DUP, from early childhood through adulthood. By identifying patterns of socialization difficulties, this innovative study will allow to efficiently prepare future therapeutic trials, by specifying the phenotype of the patients, and by determining the most relevant outcome measures, taking into account, on one hand, their neurodevelopmental involvement and, on the other hand, the type of experimental design to be used in the context of rare diseases.",[170,31,171],"7q11.23 Microduplication Syndrome (7DUP)","Neurodevelopmental Disorders (NDD)",[173,174,175,176,30],"7q11.23 microduplication","7DUP syndrome","neurodevelopmental disorders","autism spectrum disorder","2026-07-31",{"date":179,"type":52},"2026-08-03",{"date":181,"type":52},"2026-07-15",{"date":183,"type":21},"2028-01-01",{"name":185,"class":59},"Hospices Civils de Lyon",{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":16,"minAge":192,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":216},"100650417","promoting-physical-activity-among-young-children-with-autism-100650417","NCT07747129","Promoting Physical Activity Among Young Children With Autism","Inclusion Criteria:\n\n* Only 1 teacher-child dyad per early childhood education program\u002Fschool will be enrolled in the study.\n* Teachers are eligible to participate if: they are a lead teacher in a classroom with at least one child with autism; the autistic child's parent\u002Fguardian consented for their child to participate; and the teacher has not previously completed WE PLAY.\n* Children are eligible to participate if: they are between the ages of 2.9 - 5.11 years at the pre-training assessment, they have a previous diagnosis of autism, and their teacher is participating.\n\nExclusion Criteria:\n\n* Children who do not have a diagnosis of autism, or whose family plans to move away from the area before the study ends will be excluded from the study.","33 Months","71 Months",{"count":195,"type":21},300,[73],"Higher amounts of physical activity are linked to multiple health benefits including improved cognition, academic success, and classroom behavior for children. These relationships start in early childhood during the preschool years. Additional research is needed to determine the rates of physical activity among children with autism spectrum disorder. However, research suggests that compared to their typically developing peers, children with autism participate in fewer types of physical activities, often have delays in a range of motor skills, and face physical activity barriers including behavior problems, social communication challenges, and adults' uncertainty about how to modify physically active games to include them. Young children need adult guidance, support, and opportunities to be more active, and early care and education programs are a critical setting for physical activity promotion.\n\nFaculty at Northeastern University developed and pilot tested WE PLAY (Wellness Enhancing Physical Activity for Young Children), a teacher training, that is accessed online at no cost. WE PLAY was designed to promote physical activity at the child-level, to promote knowledge, confidence, and skills to lead active play at the teacher-level, and to impact social and environmental challenges at the program-level. Three three pilot studies demonstrated that WE PLAY was efficacious in increasing physical activity when implemented with preschoolers with and without autism and it was viewed as feasible, understandable, and acceptable by early childhood educators.\n\nThis clinical trial will test the efficacy of WE PLAY in children with autism spectrum disorder and their teachers. The researchers hypothesized that at post-training and follow-up, children in the WE PLAY group will engage in higher levels of physical activity in school relative to children in the control group. Further, the researchers hypothesized that at post-training and follow-up teachers in the WE PLAY group will demonstrate increased behavior intentions, perceived behavior control to perform physical activity facilitating behaviors relative to control group teachers. Additionally, this study will explore the effects of malleable teacher and system-level factors between the intervention and child physical activity. The researchers hypothesized that malleable teacher and system variables including behavior intentions, perceived behavior control, physical activity promotion practices, teachers' perceived physical activity promotion role, teacher autonomy, and supervisor support will mediate or moderate the relationship between study group and child physical activity levels.\n\nA national sample of 150 teacher-child dyads from early childhood education programs across the United States will be randomized into two conditions (WE PLAY vs. Control). Data will be collected across three periods over 20 weeks (pre-training = 0 weeks, post-training = 4 weeks, follow-up = 20 weeks). WE PLAY teachers will be asked to complete the WE PLAY training. Control group teachers will complete another online training on a topic that is not related to physical activity. Children with autism (ages 2.9 to 5.11) will wear accelerometers during waking hours for five consecutive days at each of the three data collection periods and their teachers will complete online surveys at each of the three data collection periods.\n\nThe proposed study addresses a critical need for young children with autism. If WE PLAY is determined to be efficacious on a large scale it would lead to interventions that could be integrated in a variety of settings, including early care and education programs and community settings, which could improve physical activity levels in young children, setting them up for greater success throughout their lives.",[31],[200,201,202,203,79,204,205,206],"preschool","physical activity","teacher","child","professional development","online","early childhood education","2026-07-30",{"date":209,"type":52},"2026-08-05",{"date":211,"type":21},"2026-09",{"date":213,"type":21},"2030-05",{"name":215,"class":59},"Northeastern University",3,{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":225,"minAge":69,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":60},"100582666","phase-2-suramin-for-the-treatment-of-autism-trial-kz101-in-a-male-pediatric-population-with-autism-spectrum-disorder-asd-100582666","NCT06866275","Suramin for the Treatment of Autism Trial: KZ101 in a Male Pediatric Population With Autism Spectrum Disorder (ASD)","Suramin for the Treatment of Autism Trial (STAT): A Randomized, Double Blind, Crossover Trial of KZ101 in a Male Pediatric Population With Autism Spectrum Disorder","STAT-2A","Inclusion Criteria:\n\n\\- Subject must meet all of the following criteria to be enrolled in this study.\n\n1. Male, aged 5-14 years\n2. Clinical diagnosis of ASD by DSM-5 criteria\n3. ADOS-2 ≥ 7 on the comparison score for Modules 2-4 (completed within the last 2 years).\n4. CGI-S ≥ 4 for socialization specific symptoms of ASD\n5. Leiter-3 non-verbal IQ \\> 70\n6. Standard score \\\u003C 75 on the Socialization Domain of the Comprehensive Interview Form of the Vineland Adaptive Behavior Scale Third Edition\n7. Subjects who are sexually active or potentially sexually active agree to use condoms with a spermicidal as a barrier method of contraception during the treatment period and for at least 30 days after the last dose of study medication\n8. Subjects agree to wear sunscreen and to wear skin covering to the maximal degree tolerated by the child for the duration of the treatment period and for at least 30 days after the last dose of study medication\n9. Subjects must have a ≤ 90 minutes car ride from the study site\n10. English-speaking child and parent\u002Fguardian or caregiver\n11. Parent or their legal guardians must be willing to sign informed consent\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria will be excluded from the study.\n\n  1. ASD diagnosis with underlying syndromic diagnosis (e.g., Fragile X, Angelman, Down's Syndrome, etc.)\n  2. ≤ 5th percentile for weight\n  3. Unable to tolerate venipuncture or urine collection\n  4. Acute infection (e.g., upper respiratory tract infection, common cold, flu, strep, COVID-19)\n  5. Severe co-morbid conditions (e.g., psychosis, seizures\u002Fepilepsy uncontrolled by medication, presence of severe visual or hearing impairment) that may interact with study procedures. Controlled epilepsy is allowed providing there has not been a breakthrough seizure in the past year.\n  6. Any organ system dysfunction, especially liver (e.g., ALT or AST ≥ 1.5x the upper limit of normal), kidney (estimated glomerular filtration rate or eGFR \\\u003C 90 mL\u002Fmin\u002F1.73 m2; hematuria confirmed by urine microscopy \\[ \\> 5 red blood cells\u002Fhigh power field\\]; proteinuria \\[\\> 1+ that does not resolve on repeat testing or urine protein to creatinine ratio \\> 0.3\\]; and\u002For presence of any granular, mixed cellular, red blood cell, white blood cell, or muddy brown casts on urine microscopy), or clinically relevant heart or adrenal abnormalities\n  7. Hospitalization within the previous 2 months from screening\n  8. Initiation or change in pharmacotherapy within previous 2 months from screening\n  9. Initiation or change in psychosocial interventions (formal behavioral, cognitive, or cognitive-behavior therapy) within previous 2 months from screening\n  10. Plan to initiate or change pharmacotherapy or psychosocial interventions during the study\n  11. Taking prescription medication that may interact adversely with KZ101 or expose the subject to increased risk of harm such as medications with plasma bound substances including sulfonamides, chlorpromazine, and anti-coagulants\n  12. Currently enrolled in another clinical study or has received any investigational treatment within 30 days of screening\n  13. Taking \\> 3 medications addressing behavioral symptoms related to ASD (ie typical\u002Fatypical antipsychotics and alpha-adrenergic agonists) or comorbid medical conditions such as ADHD, anxiety, or depression. Anti-seizure medications and other medications not related to neurobehavioral symptoms do not count towards the total number of medications allowed.\n  14. History of serious dermatological reactions\n  15. History of allergy, intolerance, or photosensitivity to any drug\n  16. Unable or unwilling to adhere to study requirements","MALE","14 Years",{"count":228,"type":21},45,[25],"Suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism. A preliminary clinical trial (SAT-1) examined the safety and activity of a single low-dose of suramin in children with ASD and concluded suramin showed promise as a novel approach to treatment of ASD. The current study, STAT-2A, will be a randomized, double-blind, crossover, 30-week study to evaluate the preliminary proof of concept, safety, and PK of suramin sodium (KZ101) with repeat dosing by IV infusion in males 5-14 years of age who have been diagnosed with ASD. The study will be conducted at approximately 3 sites contributing approximately 15 subjects per site. Total enrollment of approximately 45 subjects is planned to achieve approximately 36 participants completing the study.",[31],[233,234],"Suramin","suramin sodium","2026-07-29",{"date":207,"type":52},{"date":238,"type":52},"2025-04-09",{"date":240,"type":21},"2028-04",{"name":242,"class":59},"Children's Hospital of Orange County",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":265,"locationsCount":88},"100611667","phase-1-prospective-clinical-study-on-human-umbilical-cord-mesenchymal-stem-cell-derived-exosomes-for-the-treatment-of-childhood-autism-100611667","NCT07243561","Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism","EXO-ASD","Inclusion Criteria:\n\n* Diagnosis meets the ICD-11 ASD criteria or DSM-5 ASD clinical diagnostic standards.\n* No significant improvement in core symptoms was observed after ≥3 months of standardized behavioral intervention.\n* Score ≥30 on the CARS2, indicating mild-to-moderate or more severe autism.\n* Aged 3 (inclusive) to 7 (inclusive) years, regardless of gender\n* Voluntary participation in this clinical study, with written informed consent provided by the patient's legal guardian, and willingness to undergo examinations, treatment, and cooperate with follow-up visits.\n* In the investigator's judgment, the patient is capable of understanding and complying with study requirements.\n\nExclusion Criteria:\n\n* History of severe allergic reactions.\n* Any severe mental disorder or other types of autism spectrum disorders.\n* History of epileptic seizures within the past six months.\n* Autism secondary to epilepsy, cerebrovascular disease, or traumatic brain injury.\n* Disease severity rated as normal, borderline mental disorder, or mild mental disorder on the Clinical Global Impression scale.\n* Moderate or severe extrapyramidal symptoms or tardive dyskinesia.\n* Severe self-injurious behavior.\n* Active systemic or severe localized infections, including human immunodeficiency virus, syphilis, and hepatitis.\n* Autoimmune diseases.\n* Major organ impairment.\n* Severe pulmonary or hematological diseases, malignancies, or immunodeficiency.\n* Concurrent treatments that may interfere with the safety and efficacy evaluation of stem cell therapy.\n* Participation in other clinical trials within the past three months.\n* Other clinical conditions deemed by investigators as unsuitable for study inclusion.","7 Years",{"count":252,"type":21},60,[24,25],"This clinical study aims to evaluate whether a nasal spray containing exosomes derived from human umbilical cord mesenchymal stem cells (hUC-MSC-EXOs) can safely and effectively improve core symptoms in children aged 3-7 years with autism spectrum disorder (ASD). It is a 24-week, non-randomized, controlled, open-label trial. Sixty pediatric patients with ASD will be non-randomly assigned at a 1:2 ratio to two groups: a no-intervention control group and an active exosome nasal spray treatment group. The treatment group will receive the nasal spray on Mondays, Wednesdays, and Fridays, totaling 10 administrations throughout the study. The no-intervention control group will receive no experimental treatment but will undergo the same assessments and safety checks with the treatment group. This design aims to monitor the safety and efficacy of the hUC-MSC-EXOs nasal spray.",[103,256],"Prospective Study",[28,258,259],"umbilical cord mesenchymal stem cells","exosome",{"date":261,"type":52},"2026-07-16",{"date":263,"type":52},"2025-09-01",{"date":207,"type":21},{"name":266,"class":59},"Dongfang People's Hospital",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":276,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":60},"100645461","teleaba-for-hospitalized-adolescents-and-young-adults-with-autism-spectrum-disorder-100645461","NCT07701915","TeleABA for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder","Transforming Hospitalizations of Autistic Adolescents Via a Novel ABA Telehealth Platform","Inclusion Criteria:\n\n* Age 12 years or older.\n* Established or documented diagnosis of autism spectrum disorder (ASD) in the electronic medical record or confirmed by the attending provider using DSM-5 criteria.\n* Admitted to a participating Hackensack Meridian Health hospital due to behavioral concerns (e.g., aggression, self-injury, elopement, or property destruction) that contribute to or prolong hospitalization.\n* Behavioral support identified by the attending provider as a primary component of the current admission.\n* Caregiver or legally authorized representative (LAR) able to provide informed consent.\n* Patient assent obtained when applicable.\n* Voluntary, court-mandated, and ward-of-the-state admissions are eligible.\n\nExclusion Criteria:\n\n* Admission for an acute medical condition in which behavioral concerns are not a primary driver of hospitalization.\n* Medical instability that precludes participation in telehealth sessions.\n* Absence of a caregiver or legally authorized representative able to provide informed consent.",{"count":275,"type":21},120,[73],"This study is evaluating whether a telehealth-based applied behavior analysis (ABA) program can improve the care of adolescents and young adults with autism spectrum disorder (ASD) who are hospitalized because of severe challenging behaviors, such as aggression, self-injury, property destruction, or elopement.\n\nParticipants will be randomly assigned to receive either standard hospital care alone or standard hospital care plus a Telehealth Applied Behavior Analysis for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder (TeleABA) program. The TeleABA program includes assessment by a Board Certified Behavior Analyst (BCBA), individualized behavior support recommendations, coaching for hospital staff, caregiver training, discharge planning, and four weekly telehealth sessions with caregivers after the participant leaves the hospital.\n\nResearchers will compare the two groups to determine whether the TeleABA program improves behavioral outcomes, caregiver confidence and stress, hospital experiences, and the transition from the hospital to home. The findings may help identify more effective ways to support individuals with autism and their families during and after behavioral health hospitalizations.",[31],[28,280,281,282,283,284,285,286],"Applied Behavior Analysis (ABA)","Telehealth","Caregiver Training","Challenging Behavior","Crisis Prevention","Behavioral Crisis","Hospitalization","2026-07-13",{"date":289,"type":52},"2026-07-14",{"date":291,"type":21},"2026-08-01",{"date":293,"type":21},"2027-07-31",{"name":295,"class":296},"Caring Technologies, Inc.","INDUSTRY",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":16,"minAge":96,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":315,"leadSponsor":317,"locationsCount":88},"100606024","navigating-the-transition-to-adulthood-a-dual-language-mobile-app-for-latino-youth-with-asd-and-their-families-100606024","NCT07170163","Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families","Inclusion Criteria:\n\n* Latino young adults with ASD ASD with a score of 15 or greater on the Social Communication Questionnaire-Lifetime (SCQ-L)\n* meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR), criteria for ASD based on a DSM-5-TR ASD symptom checklist\n* previous diagnosis of ASD from a licensed mental health or medical professional(f they have not been diagnosed by a licensed mental health or medical professional, a complete a diagnostic evaluation will be conducted, using semi-structured interviews, questionnaires, the autism diagnostic interview-revised (ADI-R), and the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) to confirm ASD diagnosis)\n* above the \"moderate\" cut off for symptoms of anxiety or depression( Depression and anxiety symptoms will be assessed via the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder-7 (GAD-7)\n* Spanish-speaking parents\n\nExclusion Criteria:\n\n* low intelligence quotient (IQ) score (Verbal IQ \\\u003C 70) on the verbal IQ on Kaufman Brief Intelligence Test Second Edition (KBIT-2)\n* psychotic as determined by the Structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5): Research Version (SCID-5-RV), or are actively suicidal with an active plan.\n* substance abuse","25 Years",{"count":305,"type":21},30,[73],"The purpose of this study is to determine useability and satisfaction characteristics,product usage data,methodological feasibility parameters and feasibility metrics of the mHealth app adapted intervention on the mental health, quality of life, and adaptive functioning of Latino transition aged young adults with ASD and their parents.",[31],[310],"mHealth app","2026-07-08",{"date":313,"type":52},"2026-07-10",{"date":291,"type":21},{"date":316,"type":21},"2027-06-30",{"name":318,"class":59},"The University of Texas Health Science Center, Houston",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":16,"minAge":326,"maxAge":327,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":331,"conditions":332,"keywords":333,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":88},"100633092","trial-of-center-based-early-start-denver-model-vs-pivotal-response-treatment-in-children-with-autism-100633092","NCT07522190","Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism","Randomized Controlled Trial of Center-Based Early Start Denver Model (ESDM) vs. Pivotal Response Treatment (PRT) in Children With Autism","Inclusion Criteria:\n\n* Children must be between 2 and 4 years, 11 months of age at enrollment\n* Confirmed diagnosis of autism spectrum disorder based on standardized diagnostic assessments and clinical judgment\n* Demonstrated significant language delay as determined by standardized language measures\n* Ability to participate in study assessments and intervention procedures\n* At least one English-speaking parent or caregiver available to participate in parent training and research measures\n* Receiving stable community-based treatments or medications for at least one month prior to baseline, with no anticipated changes during the study period\n\nExclusion Criteria:\n\n* Current or lifetime diagnosis of a severe psychiatric disorder (e.g., bipolar disorder)\n* Presence of an active or unstable medical condition (e.g., uncontrolled seizure disorder or significant cardiac disease)\n* Child's primary language is not English\n* Prior adequate trial of PRT or ESDM\n* Receipt of more than 15 hours per week of in-home applied behavior analysis services\n* Inability to complete study assessments or procedures to obtain valid data","2 Years","4 Years",{"count":329,"type":21},140,[73],"The goal of this study is to compare two well-established early autism interventions, Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT), to better understand which approach is most effective for improving communication skills in young children with autism and which children may benefit most from each treatment. Additionally, after completing either the ESDM or PRT, some participants who meet specific clinical criteria may be offered home-based Developmental Reciprocity Treatment (DRT). The study will include boys and girls 2 to 4 years 11 months old diagnosed with ASD. The main questions this study aims to answer are whether center-based ESDM and center-based PRT improve communication skills in young children with autism, and whether certain children respond better to one treatment approach than the other. Participants will be randomly assigned to either ESDM or PRT for 24 weeks in a center-based program, attend treatment session 4 days per week (\\~3 hours\u002Fday), complete developmental and autism assessments at baseline, 12 weeks, and 24 weeks, have a parent participate in weekly parent training sessions, and complete follow-up assessments at weeks 36 and 48.",[31,29],[29,28,334,335,336,337,338,339,340,341],"Early Start Denver Model (ESDM)","Pivotal Response Treatment (PRT)","Early Intervention","Naturalistic Developmental Behavioral Intervention (NDBI)","Communication","Early Development","Parents","Language","2026-07-06",{"date":311,"type":52},{"date":345,"type":21},"2027-01",{"date":347,"type":21},"2037-01",{"name":349,"class":59},"Stanford University",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":68,"sex":16,"minAge":327,"maxAge":18,"enrollmentInfo":357,"targetDuration":359,"studyType":360,"phases":4,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":88},"100643518","how-trunk-control-links-autism-severity-to-functional-exercise-capacity-in-children-with-asd-100643518","NCT07634107","How Trunk Control Links Autism Severity to Functional Exercise Capacity in Children With ASD","Trunk Control Mediates the Association Between Autism Severity and Functional Exercise Capacity in Children With Autism Spectrum Disorder","Inclusion Criteria:\n\n* Children aged 4-12 years (inclusive) at the time of assessment\n* Confirmed diagnosis of ASD according to DSM-5 criteria, documented in the hospital record by a licensed clinical psychologist or developmental paediatrician\n* Classified at DSM-5 severity Level 1, 2, or 3 in the existing clinical file\n* Currently attending physiotherapy or developmental rehabilitation outpatient services at the hospital\n* Able to attempt the Six-Minute Walk Test (6MWT) with or without verbal prompting\n* Written informed consent from parent or legal guardian; verbal assent from child where developmentally appropriate (aged 7 years and above)\n\nExclusion Criteria:\n\n* Co-existing neurological condition independently affecting gait (e.g., cerebral palsy, uncontrolled epilepsy)\n* Orthopaedic condition precluding walking or safe execution of the Trunk Impairment Scale\n* Acute illness, fever, or significant behavioural crisis at the time of the scheduled assessment session\n* Current enrolment in a structured physiotherapy or physical activity intervention programme\n* Caregiver refusal of consent or participant non-cooperation with either assessment tool at the time of the visit",{"count":358,"type":21},200,"1 Day","OBSERVATIONAL","The goal of this observational study is to learn if trunk control (the ability to balance and stabilize the upper body while sitting or moving) links autism severity to functional exercise capacity in children aged 4-12 years with Autism Spectrum Disorder (ASD). The main questions it aims to answer are:\n\n1. Does trunk control explain why children with more severe ASD have lower functional exercise capacity?\n2. Do trunk control and functional exercise capacity differ across ASD severity levels (Level 1, 2, and 3)?\n\nParticipants will complete two assessments in a single 30-40 minute session during their routine clinic visit:\n\n1. A trunk control test, where a trained physiotherapist observes seated balance and movement.\n2. A 6-Minute Walk Test (6MWT), where the child moves along a flat hospital corridor for 6 minutes and the total distance covered is recorded as a measure of functional exercise capacity.\n\nNo treatment or intervention is involved. All assessments are safe, non-invasive, and conducted at a tertiary care children's hospital in Pakistan.",[31],"2026-06-06",{"date":365,"type":52},"2026-06-10",{"date":367,"type":21},"2026-06",{"date":369,"type":21},"2026-07",{"name":371,"class":59},"Dr. Mehak Naeem",{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":380,"briefSummary":381,"conditions":382,"keywords":383,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":388,"leadSponsor":389,"locationsCount":60},"100637682","phase-1-gaip-asd-research-study-100637682","NCT07622316","GAIP ASD Research Study","Greater Atlanta Integrative Pediatrics Autism Spectrum Disorder Research Study","Inclusion Criteria:\n\n* Age 3 years and up\n* Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2 or its equivalent)\n* Parent\u002Fguardian willingness to consider experimental treatments and comply with study requirements\n* Ability to obtain required bloodwork\n* Ability to attend all scheduled visits\n\nExclusion Criteria:\n\n* Severe allergies to study products\n* Significant uncontrolled medical conditions\n* Immunocompromised\n* Malignancy history\n* Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion\n* Pregnancy or breastfeeding (if applicable)\n* Participation in another interventional trial within 30 days",{"count":20,"type":21},[24],"This clinical research study evaluates the safety and preliminary effects of AdiaVita (umbilical cord blood-derived stem cells and exosomes) combined with glutathione versus glutathione alone in people aged 3 and older with Autism Spectrum Disorder (ASD). In this randomized, participant-blinded crossover trial of about 100 participants, one group receives three monthly AdiaVita IV infusions plus glutathione, while the control group gets placebo saline infusions with the same glutathione regimen; the primary outcome is improvement on Autism Treatment Evaluation Checklist (ATEC) scores, with full safety follow-up through 12 months and optional crossover to AdiaVita for eligible controls. The treatment is investigational and not FDA-approved for autism, with no guaranteed benefit and risks including infusion reactions; participants pay $12,000 for the initial schedule, and all data remains confidential.",[28,29,30,31],[33,34,35,36,37,38,39,29,28,30,40,41,44,47,45],"2026-06-01",{"date":386,"type":52},"2026-06-03",{"date":384,"type":21},{"date":316,"type":21},{"name":390,"class":59},"Greater Atlanta Integrative Pediatrics",{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":68,"sex":16,"minAge":326,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":360,"phases":4,"briefSummary":400,"conditions":401,"keywords":403,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":88},"100639915","online-evaluation-of-the-diagnostic-accuracy-of-blinklabs-digital-assessments-for-autism-100639915","NCT07590973","Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism","Inclusion Criteria:\n\n1. Age: Children between 2 to 11 years old\n2. Parent\u002FCaregiver\u002FHealthcare Provider Concern: The child has received a diagnostic outcome of a neurodevelopmental assessment based on DSM-5 criteria within the past 12 months.\n3. Language Proficiency: Parents and subjects must have functional English capability in the home environment.\n4. Informed Consent: Parents must be able to read, understand, and voluntarily sign the Informed Consent Form (ICF).\n5. Videotaping: subjects must be willing to be videotaped during the diagnostic assessment by the BlinkLab App.\n\nExclusion Criteria:\n\n1. Device Compatibility: Parents without smartphone capabilities necessary for using the BlinkLab app.\n2. Previous Enrollment: Subjects who have been previously enrolled in any BlinkLab clinical study.\n3. Location of at home testing: Not being able to complete all remote at-home study sessions within the US.\n4. History of audiogenic seizures: Participants with a known history of seizures that are triggered by auditory stimuli, including reflex or startle epilepsy provoked by sounds (audiogenic seizures), or any other form of sound-induced epilepsy.","11 Years",{"count":399,"type":21},1000,"This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11. BlinkLab Dx1 is a non-invasive, smartphone-based application under development as a diagnostic aid for healthcare providers assessing autism.\n\nIn this study, children who have undergone a neurodevelopmental assessment within the past 12 months will complete two short, video-based sessions using the BlinkLab Dx1 app. The app presents visual and auditory stimuli and records reflexive sensorimotor responses and patterns of repetitive behavior. Additionally, primary caregivers will answer a short questionnaire in the app about symptoms and development. Information about prior neurodevelopmental assessments, including documented DSM-5-based diagnoses from routine clinical practice, will be collected retrospectively.\n\nThe study will examine how the app's neurobehavioral measurements relate to previously assigned clinical diagnoses. These paired data will be used to develop and evaluate a machine learning-based algorithm using separate training and testing datasets to assess whether patterns measured by BlinkLab Dx1 can help distinguish children with autism from children without an autism diagnosis.\n\nThis study does not involve any treatment or medical intervention.",[29,28,31,402],"Neurodevelopmental Conditions",[28,29,404,402,405,406,407,408,409,410,411,412,413,414,415],"Autism Diagnosis","Pediatric Assessment","Digital Assessment","Mobile Application","Smartphone-based Assessment","Digital Health","Remote Study","Observational Study","Eye Movements","Repetitive Behavior","Reflexive Sensorimotor Behavior","Machine Learning","2026-05-11",{"date":418,"type":52},"2026-05-15",{"date":420,"type":52},"2025-02-15",{"date":422,"type":21},"2026-12-01",{"name":424,"class":296},"Blinklab Limited",{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":16,"minAge":432,"maxAge":433,"enrollmentInfo":434,"targetDuration":4,"studyType":360,"phases":4,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":88},"100618288","an-examination-of-the-performance-of-qbmobile-in-differential-diagnosis-associated-with-adhd-symptoms-100618288","NCT07329673","An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms","An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms.","Inclusion Criteria:\n\n* Provide written informed consent (including parent\u002Flegal guardians consent when this is required for individuals under 18 years old and assent as is required based on the age of participant) for QbMobile;\n* Aged \\> 6 years and \\\u003C 60 years old;\n* Referred for an initial assessment for ASD, MDD, Bipolar Disorder or Anxiety Disorder (Separation Anxiety Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder (GAD)) or has a prior diagnosis of one of the included disorders but is not currently receiving treatment;\n* Meets DSM-5 or ICD-11 criteria for a primary diagnosis of ASD, MDD, Bipolar Disorder or Anxiety Disorder per sites standard clinical procedures;\n* Have adequate sensory and physical ability to complete QbMobile;\n* Possess or have access to an iPhone model that supports QbMobile.\n\nExclusion Criteria:\n\n* Intellectual disability designated by IQ\\\u003C70;\n* Has a DSM-5 or ICD-11 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder;\n* Has a primary diagnosis of ADHD (combined, inattentive, or hyperactivity\u002Fimpulsive presentation);\n* Has a concurrent medical diagnosis that could significantly affect test performance such as brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g. vascular dementia, Alzheimer disease, etc);\n* Has other conditions that could affect test performance (migraine or other types of severe headache, chronic or acute pain);\n* Use of prescription medications (e.g., anxiolytics, sedative medications) taken on the day before completing QbMobile that could significantly affect performance;\n* Substance use (e.g., alcohol, drugs) that may affect performance on the day of the tests.","6 Years","60 Years",{"count":195,"type":21},"The purpose of this study is to evaluate QbMobile's ability to collect objective data to identify specific symptom profiles in differential diagnoses (ASD, MDD, Bipolar Disorder and Anxiety Disorder) that are common with ADHD.",[437,31,438,439,440,441],"Bi-Polar Disorder","Major Depression Disorders","Separation Anxiety Disorder","Social Anxiety Disorder","Generalized Anxiety Disorder (GAD)","2026-05-04",{"date":444,"type":52},"2026-05-06",{"date":446,"type":52},"2026-01-01",{"date":448,"type":21},"2026-11",{"name":450,"class":296},"Qbtech AB",{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":68,"sex":16,"minAge":459,"maxAge":303,"enrollmentInfo":460,"targetDuration":4,"studyType":360,"phases":4,"briefSummary":462,"conditions":463,"keywords":466,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":472,"leadSponsor":474,"locationsCount":88},"100636799","biomarkers-of-asdadhd-and-factors-affecting-anxiety-and-depression-in-children-and-young-adults-100636799","NCT07570381","Biomarkers of ASD\u002FADHD and Factors Affecting Anxiety and Depression in Children and Young Adults","Biomarker Discovery for Predicting Autism Spectrum Disorder and Attention\u002FHyperactivity Disorders, and Identification of Environmental Factors Influencing Anxiety and Depression in Children, Adolescents, and Young Adults","PUREMIND-OS","OS1 Inclusion Criteria:\n\n* Infants born very preterm (\\\u003C32 weeks) or extremely preterm (\\\u003C28 weeks); or\n* Term-born infants with documented perinatal asphyxia and hypoxic-ischaemic encephalopathy (HIE); or\n* Term-born infants with no risk factors (comparison group).\n* Must be ≤12 months corrected age at enrolment.\n\nOS1 Exclusion Criteria:\n\n* Syndromic, chromosomal, or known genetic conditions.\n* Motor impairments that would prevent participation in psychometric or neurophysiology assessments.\n\nOS2 Inclusion Criteria:\n\n* Individuals aged 5-25 years.\n* Clinical diagnosis of ASD, ADHD, or Developmental Coordination Disorder (DCD).\n* Able to participate in scheduled assessments.\n\nOS2 Exclusion Criteria:\n\n* Severe motor impairments that limit psychometric assessment.\n* Diagnosis of schizophrenia, due to confounding neurocognitive effects.","6 Months",{"count":461,"type":21},800,"The PUREMIND OS1\u002FOS2 study is a multinational, prospective, longitudinal observational study designed to identify early neurophysiological, biological, environmental, and psychosocial markers associated with neurodevelopmental and mental health conditions from infancy through young adulthood.\n\nObservational Study 1 (OS1) follows infants and toddlers at high risk for Autism Spectrum Disorder (ASD) and Attention-Deficit\u002FHyperactivity Disorder (ADHD) to discover biomarkers predictive of later clinical diagnosis, using EEG, fNIRS, psychometric assessments, and biological samples.\n\nObservational Study 2 (OS2) includes children, adolescents, and young adults with ASD, ADHD, or Developmental Coordination Disorder (DCD) to identify environmental and biological factors causally linked to anxiety and depression symptoms, and to support the development of personalised criteria for evidence-based interventions.\n\nApproximately 800 participants will be recruited across 10 international clinical sites. The study aims to generate multi-domain data to support predictive modelling and inform future personalised mental-health prevention strategies across childhood and young adulthood.",[464,31,465],"ADHD - Attention Deficit Disorder With Hyperactivity","Developmental Coordination Disorder (DCD)",[467,106,468],"Attention Deficit Disorder with Hyperactivity","Developmental Coordination Disorder","2026-04-29",{"date":444,"type":52},{"date":291,"type":21},{"date":473,"type":21},"2028-12-31",{"name":475,"class":59},"University of Exeter",{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":16,"minAge":432,"maxAge":226,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":484,"briefSummary":485,"conditions":486,"keywords":488,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":503,"leadSponsor":505,"locationsCount":4},"100618026","school-based-sensory-processing-and-daily-living-skills-focused-occupational-therapy-program-100618026","NCT07326267","School-Based Sensory Processing and Daily Living Skills-Focused Occupational Therapy Program","Development and Evaluation of a School-Based Occupational Therapy Program Focused on Sensory Processing and Activities of Daily Living: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Regular school attendance (Anticipated ability to attend at least 70% of the planned intervention sessions during the study period);\n* Written informed consent obtained from the family;\n* Formal diagnosis of Autism Spectrum Disorder or Intellectual Disability, documented by an official disability report;\n* Presence of observable difficulties in sensory processing and activities of daily living (ADL), verified through the student's Individualized Education Program (IEP) records;\n* Ability to partially follow single-step basic instructions, as documented in the IEP records;\n* Willingness of families and teachers to participate in follow-up assessments (T2 and beyond).\n\nExclusion Criteria:\n\n* Uncontrolled epilepsy or other medical conditions that may interfere with participation or safety during sessions.\n* Medical contraindications to modalities such as swinging or deep pressure or severe musculoskeletal limitations preventing participation in task-oriented ADL practice.\n* Being in a period of severe acute behavioral crisis;\n* Concurrent participation in occupational therapy or special education programs for ≥2 hours per week that would compromise data interpretation;\n* Presence of severe visual or hearing impairments that would substantially limit the child's ability to perceive sensory stimuli, follow task instructions, or validly engage in assessment procedures;\n* Inability to maintain family and\u002For teacher collaboration throughout the intervention period;\n* Inconsistent school attendance during the intervention period (e.g., prolonged absenteeism);\n* Insufficient language comprehension to engage with basic task instructions even with support.",{"count":132,"type":21},[73],"This study aims to develop and evaluate a school-based occupational therapy program focused on sensory processing and activities of daily living for children with Autism Spectrum Disorder and Intellectual Disability. Sensory processing difficulties often affect school participation, behavior regulation, and independence in daily tasks. Although occupational therapy interventions have shown benefits in clinical settings, evidence for their use in schools is limited.\n\nThe trial will take place at Vali Ayhan Çevik Special Education School and will enroll students aged 6 to 14 years. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive weekly 50-minute occupational therapy sessions for 10 to 12 weeks, including sensory preparation, task-oriented practice, and strategies to support everyday skills. The control group will receive family education, a written home program, and routine school observation.\n\nOutcomes will be assessed at baseline, after the intervention, and at 4 to 6-week follow-up. The main outcome is change in Goal Attainment Scaling scores, which reflect progress toward individualized goals. Additional measures include functional ability, sensory processing, and demographic and clinical information. The study will also monitor feasibility and how closely the program is delivered as planned.\n\nThis research is expected to provide evidence on the feasibility and effects of a standardized occupational therapy program in a school setting and to support the use of similar approaches in educational contexts.",[487,31],"Intellectual Disability, Variable",[489,490,491,492,493,494,495,496,497,498],"School-Based Occupational Therapy","Sensory Processing Intervention","Activities of Daily Living (ADL)","Intellectual Disability (ID)","Randomized Controlled Trial","Feasibility Trial","Goal Attainment Scaling (GAS)","Special Education School","Independence","Sensory Integration","2026-04-08",{"date":501,"type":52},"2026-04-09",{"date":442,"type":21},{"date":504,"type":21},"2027-03-01",{"name":506,"class":59},"Çankırı Karatekin University",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":68,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":22,"phases":516,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":88},"100625376","an-empowering-parent-training-intervention-to-increase-physical-activity-in-preschool-aged-children-with-autism-100625376","NCT07421830","An Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism","An Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism: A Randomized Control Trial","Inclusion Criteria:\n\n* Parents or caregivers (who are at least 18 years of age) of children with a diagnosis of autism.\n* The autism diagnosis for the child can be from a school or medical setting.\n* The parent or caregiver's child with autism must be between 2 years 11 months and 5 years, 11 months of age.\n* Parent or caregivers must be able to read and write in English.\n\nExclusion Criteria:\n\n* Parents or caregivers who do not have a child with autism.\n* Adults who do not have children.\n* Parents or caregivers who cannot read and write in English.",{"count":515,"type":21},114,[73],"The goal of this clinical trial is to learn if WE PLAY for Parents can improve caregivers' knowledge, attitudes, confidence, and skills promoting physical activity with their young child with autism. The main questions it aims to answer are: (1) Do participants who complete WE PLAY for Parents improve their knowledge, behavior intentions, perceived behavior control, self-efficacy, and parenting practices related to physical activity promotion with their child (Primary Hypotheses); and (2) Do participants view WE PLAY for Parents as acceptable, understandable, and feasible \\[secondary hypothesis)?\n\nResearchers will compare the WE PLAY for Parents group \\[experimental arm\\] to a Waitlist Control group to see if there are differences in the variables listed in the primary hypothesis.\n\nParticipants will: (1) Complete a set of questionnaires at three timepoints: pre-training, post-training, and 3-month follow-up that each take between 10-15 minutes; (2) be randomly assigned to take the training over the next two weeks or be offered the training after 3 months.\n\nThe online training takes about 90 minutes. It includes watching informational videos, viewing video clips of adults helping children be active, reading handouts on behavior management tips and social stories, participating in an anonymous discussion board with other parents, and completing a self-assessment.",[31],[520,79,201,521,522,523,524],"parents","preschoolers","health promotion","active play","caregivers","2026-04-06",{"date":499,"type":52},{"date":528,"type":52},"2026-02-20",{"date":530,"type":21},"2026-12-31",{"name":215,"class":59},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":68,"sex":16,"minAge":326,"maxAge":96,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":545,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":553,"locationsCount":88},"100632875","monitoring-daily-mobility-in-children-with-autism-100632875","NCT07519369","Monitoring Daily Mobility in Children With Autism","Innovative Solution With Wearable Sensors for Monitoring Daily Mobility in Children With Autism","SIMBA","Inclusion Criteria:\n\n* Diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria\n* Age between 2 and 18 years\n* Ability to walk independently\n* Willingness to wear a wearable device (wrist sensor) continuously for 7 days and pedobarographic insoles for reproducible gait monitoring\n* Willingness to undergo one night of home polysomnography with video-EEG\u002Fpolygraphy during the wearable monitoring period\n* Informed consent signed by both parents\u002Flegal guardian; assent from the minor when applicable\n\nExclusion Criteria:\n\n* Skin contraindications to the wristband\u002Ffixation systems (known material allergies, active wrist dermatitis, or skin lesions preventing prolonged use)\n* Severe motor impairments\n* Recent orthopedic surgery (\\\u003C6 months)\n* Use of orthoses or assistive devices during walking\n* Severe behavioral disorder making device use impracticable despite acclimatization strategies",{"count":541,"type":21},80,[73],"Children with autism spectrum disorder (ASD) often show motor abnormalities and sleep disturbances that affect behavior, learning, and family quality of life. Emerging technologies such as wearable devices and markerless systems provide accessible tools for gait and sleep assessment, with actigraphy recommended for long-term monitoring in natural settings. Evidence also suggests links between sleep problems and sensory processing differences. This project, aims to integrate these approaches in a clinical-translational framework.",[103],[28,30,546,547],"sleep","movement disorders","2026-04-02",{"date":501,"type":52},{"date":551,"type":52},"2026-02-18",{"date":367,"type":21},{"name":554,"class":59},"IRCCS San Raffaele Roma",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":360,"phases":4,"briefSummary":564,"conditions":565,"keywords":567,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":88},"100631060","prospective-study-to-determine-the-prevalence-of-signs-of-central-sensitization-in-adults-with-asd-without-intellectual-developmental-disorders-100631060","NCT07495761","Prospective Study to Determine the Prevalence of Signs of Central Sensitization in Adults With ASD Without Intellectual Developmental Disorders","Presca : Prospective Study to Determine the Prevalence of Signs of Central Sensitization in Adults With ASD Without Intellectual Developmental Disorders","Presca","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Medical diagnosis of ASD without established intellectual developmental disorder\n3. Patient affiliated with a social security system or beneficiary of such a system\n4. Understanding of written French (good comprehension of self-questionnaire questions)\n5. No objection from the patient to participate in the study\n\nExclusion Criteria:\n\n1. Intellectual developmental disorder that prevents understanding of self-administered questionnaires\n2. Individuals subject to legal or judicial protection measures or unable to express their consent",{"count":20,"type":21},"Autism is a neurodevelopmental disorder (NDD) characterized by two key features: persistent deficits in communication and social interaction, and restricted, repetitive patterns of behavior, interests, and activities. Ninety-five percent of children aged 3 to 6 with autism spectrum disorder (ASD) have sensory peculiarities. In adulthood, this figure remains at 90%. This atypical sensory processing has been part of the DSM diagnostic criteria since 2013.\n\nEach sense can be affected by hypo- or hypersensitivity. In the continuum of this particular sensory processing, pain, which is defined as an unpleasant sensory and emotional experience, can be very present but also difficult to detect and manage. It is now established that there are other characteristics that impact pain in ASD: information processing time may be longer, referred to as \"latency time,\" but there are also difficulties in representing the body schema and difficulties in identifying and\u002For interpreting perceptions. Expression may be atypical, and there may be an apparent lack of reaction to pain due to a lack of flexibility.\n\nAll of these characteristics themselves vary over time (with age, the menstrual cycle, lack of sleep, fatigue, etc.), to the point that even pain specialists in pain clinics may not recognize them.\n\nIt is therefore essential to carry out appropriate, individualized assessments.\n\nThe scientific literature refers to the high frequency of painful events in ASD. For example, the prevalence of gastrointestinal disorders with their associated abdominal pain is significantly higher. Recent research has revealed that 82.4% of children and adolescents with ASD have at least one gastrointestinal symptom. Researchers have found that children with ASD are almost eight times more likely to have one or more chronic gastrointestinal symptoms than typically developing children. There are also more common comorbidities that facilitate or maintain chronic pain: Ehler Danlos syndrome and hypermobility spectrum disorders, IBD, ADHD, post-traumatic stress disorder, depression, migraines and tension headaches, anxiety disorders, epilepsy, small fiber pathologies, nutritional deficiencies, musculoskeletal disorders, etc.\n\nMutations in certain genes involved in ASD (such as SCN9A, SHANK3, and CNTNAP2) lead to impaired neuronal function, producing different responses to pain, as demonstrated in both mouse and human models. The links between ASD and chronic pain are therefore complex. Sometimes it is the unusual characteristics of the pain that could lead to a diagnosis of ASD.\n\nThe concept of central sensitization (CS), which underlies the type of pain known as \"nociplastic,\" helps explain the state of pain hypersensitivity and pathologies such as fibromyalgia and irritable bowel syndrome. In 2022, Grant et al. found that 21% of adults with ASD surveyed in the cohort reported having a diagnosis of central sensitization syndrome (CSS), but 60% scored at or above the cut-off. This suggests that CS symptoms such as pain and fatigue are very common in people with autism, and perhaps more prevalent than in the general population. For example, three-quarters of women diagnosed with ASD and\u002For ADHD in childhood report chronic pain in adulthood.\n\nThe issue is the disability associated with this chronic pain and the impairment of quality of life.",[566,31],"Pain Management",[176,568,569,570],"chronic pain","signs of central sensitization","ASD r without intellectual developmental disorder","2026-03-24",{"date":573,"type":52},"2026-03-27",{"date":575,"type":52},"2026-02-04",{"date":577,"type":21},"2027-07-29",{"name":579,"class":59},"Groupe Hospitalier Mutualiste de Grenoble",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":68,"sex":16,"minAge":326,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":360,"phases":4,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":596,"leadSponsor":598,"locationsCount":88},"100630950","exploring-the-physiological-mechanisms-of-austism-through-organoids-100630950","NCT07494331","Exploring the Physiological Mechanisms of Austism Through Organoids","Exploring the Physiologicla Mechainisms of Austism Through Organoids Derived Differentiated Cells of Individuals With Autism","EXPECT HYPE","Inclusion Criteria:\n\n* A child diagnosed with an autism spectrum disorder in accordance with clinical practice guidelines\n\n  * A sibling without an autism spectrum disorder (SRS \\\u003C 65)\n  * Biological parents\n  * Children and parents must be enrolled in a social security program, Universal Health Coverage (CMU), or an equivalent program.\n\nExclusion Criteria:\n\n* Refusal to undergo a blood test\n* Uncontrolled (unstabilized) medical condition (including psychiatric conditions) that precludes participation in the study\n* Sibling with an SRS score \\> 65 at screening or under 2 years old",{"count":541,"type":21},"Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder affecting approximately 1% of the population, characterized by difficulties with social interaction and communication. Studies have identified more than 200 genes linked to ASD, particularly those involved in chromatin remodeling and synaptic neuronal connectivity (CHD8, SCN2A, NLGN3-4X, SHANK1-3). The goal of the project is to decipher the biological mechanisms underlying ASD in order to develop therapeutic strategies, using innovative preclinical models such as organoids.",[103],[30,592],"organoid","2026-03-20",{"date":573,"type":52},{"date":54,"type":21},{"date":597,"type":21},"2028-05-01",{"name":599,"class":59},"Assistance Publique - Hôpitaux de Paris",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":16,"minAge":327,"maxAge":18,"enrollmentInfo":608,"targetDuration":4,"studyType":360,"phases":4,"briefSummary":609,"conditions":610,"keywords":631,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":88},"100630855","intensive-multimodal-neurorehabilitation-targeting-neuroplasticity-in-pediatric-neurodevelopmental-and-chromosomal-disorders-100630855","NCT07493096","Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders","Functional and Neurodevelopmental Outcomes Following Intensive Multimodal Neurorehabilitation in Pediatric Patients With Neurodevelopmental Disorders, Including Chromosomal Abnormalities","GEN-HOPE","Inclusion Criteria:\n\n* Pediatric participants between approximately 4 and 12 years of age at the time of enrollment.\n* Diagnosed with or presenting with neurodevelopmental, neurologic, or genetic conditions, including but not limited to:\n\n  * cerebral palsy\n  * autism spectrum disorder\n  * developmental delay\n  * hypoxic ischemic encephalopathy (HIE)\n  * traumatic brain injury\n  * sensory processing disorder\n  * chromosomal or genetic abnormalities\n  * Demonstrate functional impairments in one or more neurodevelopmental domains, including:\n* motor coordination or motor planning\n* sensory processing\n* attention or executive functioning\n* oculomotor or visual processing\n* communication\n* emotional or behavioral regulation\n* activities of daily living\n* Enrolled in and able to participate in a two-week intensive therapy program consisting of approximately 2.5 hours per day\u002F 5 days per week\n\n  * Able to complete baseline and post-program clinical assessment using clinician-observed or caregiver-reported measures.\n  * Parent or legal guardian able to provide informed consent and participate in reporting functional outcomes when applicable.\n\nExclusion Criteria:\n\n* Medical instability or acute medical condition that would prevent safe participation in an intensive therapy program.\n* Severe uncontrolled seizure activity or other neurologic condition that would interfere with participation in structured therapeutic activities, as determined by the treating clinician.\n* Behavioral or psychological conditions that would prevent safe engagement in the therapy environment despite appropriate support.\n* Inability to attend or complete the full two-week intensive program.\n* Lack of sufficient baseline or post-intervention data to assess change in functional performance.\n* Concurrent participation in another structured intervention or clinical study that would confound interpretation of functional outcomes, at the discretion of the investigator.",{"count":20,"type":21},"This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program. The program is designed for children with neurodevelopmental disorders, including but not limited to cerebral palsy, autism spectrum disorder, developmental delay, hypoxic ischemic encephalopathy (HIE), and chromosomal or genetic abnormalities.\n\nParticipants receive individualized therapy sessions for approximately 2.5 hours per day over a two week period. The intervention is not standardized but is tailored to each child's specific needs and may include components such as sensory integration, motor planning, reflex integration, oculomotor training, executive functioning activities, communication support, and other brain based therapeutic approaches.\n\nThe purpose of this study is to observe changes in functional abilities, including attention, motor coordination, emotional regulation, communication, and activities of daily living. Outcomes are assessed using clinician observation and parent reported changes before and after the intensive program, with limited follow-up when available.\n\nThis study does not assign participants to a specific treatment as part of a research protocol. Instead, it collects real world data from children already participating in a clinical therapy program to better understand potential benefits of intensive, individualized neurorehabilitation approaches.",[611,171,612,613,614,615,616,617,618,28,103,619,620,621,622,623,624,625,626,627,628,629,630],"Neurodevelopmental Disorders","Neurodevelopmental Disorders and Developmental Abnormalities","Developmental Delay (Disorder)","Cerebral Palsy (CP)","Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment","Cerebral Palsy Infantile","Cerebral Palsy Spastic Hemiplegic","Cerebral Palsy, Dyskinetic","Hypoxic Ischemic Encephalopathy","Hypoxic Ischemic Encephalopathy (HIE)","Traumatic Brain Injury (TBI)","Sensory Processing Disorder","Chromosomal Abnormalities","Genetic Disorders","Down Syndrome (Trisomy 21)","Fragile X Syndrome (FXS)","RETT Syndrome With Proven MECP2 Mutation","Williams Syndrome","22q11.2 Deletion Syndrome","Sensorimotor Integration",[632,633,634,635,636,637,638,639,640,641,498,642,643,644,645,646,647,648,611,649,650,651,652,336,653],"Photobiomodulation","Low-Level Laser Therapy","Vibration Therapy","Tactile Stimulation","Cognitive Training","Behavioral Therapy","Intensive Therapy","Pediatric Neurorehabilitation","Multimodal Therapy","Neuroplasticity","Reflex Integration","Motor Planning","Executive Function","Emotional Regulation","Functional Outcomes","Activities of Daily Living","High Frequency Therapy","Rehabilitation","Child Development Disorders","Occupational Therapy","Physical Therapy Modalities","Cognitive Therapy","2026-03-19",{"date":656,"type":52},"2026-03-25",{"date":658,"type":52},"2026-03-01",{"date":660,"type":21},"2036-12-30",{"name":662,"class":59},"Healing Hope International",{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":667,"acronym":4,"eligibilityCriteria":668,"healthyVolunteers":68,"sex":16,"minAge":669,"maxAge":670,"enrollmentInfo":671,"targetDuration":672,"studyType":360,"phases":4,"briefSummary":673,"conditions":674,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":4},"100629296","research-on-speech-development-trajectories-and-predictive-models-in-children-with-autism-spectrum-disorder-100629296","NCT07472829","Research on Speech Development Trajectories and Predictive Models in Children With Autism Spectrum Disorder","Inclusion Criteria:\n\n* Diagnosed as typically developing children by two or more associate chief physicians.\n* Gender- and age-matched to the ASD group.\n* Participants whose native language is Chinese.\n\nExclusion Criteria:\n\n* Participants not meeting the age requirement.\n* Presence of orofacial motor and swallowing dysfunction.\n* Hearing impairment.\n* Participants whose native language isn't Chinese.\n* Neurological disorders (such as encephalitis or seizures) and comorbid psychiatric disorders.","18 Months","60 Months",{"count":275,"type":21},"3 Months","Recent studies indicate that children with ASD have a significantly higher risk of co-occurring speech sound disorders than typically developing children. Early atypical speech development may be a critical yet overlooked bottleneck hindering their language improvement. Given the unique phonetic features of Mandarin, it is essential to investigate speech development in Mandarin-speaking children with ASD. This study aims to construct developmental trajectories and establish early identification and prognosis prediction models for this population.",[675,31],"Speech","2026-03-14",{"date":678,"type":52},"2026-03-17",{"date":680,"type":21},"2026-03-10",{"date":682,"type":21},"2027-12-31",{"name":684,"class":59},"Children's Hospital of Chongqing Medical University",{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":30,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":16,"minAge":18,"maxAge":96,"enrollmentInfo":692,"targetDuration":4,"studyType":22,"phases":694,"briefSummary":695,"conditions":696,"keywords":697,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":702,"lastUpdatePostDateStruct":703,"startDateStruct":705,"completionDateStruct":707,"leadSponsor":709,"locationsCount":88},"100586562","modified-and-context-focused-sports-intervention-in-adolescents-with-autism-study-protocol-100586562","NCT06916988","Modified and Context-Focused Sports Intervention in Adolescents With Autism: Study Protocol","Modified Sports Intervention Combined With Context-Focused Intervention in Adolescents With Autism Spectrum Disorder: Protocol for a Mixed Methods Study","Inclusion Criteria:\n\n* Diagnosis of Autism Spectrum Disorder (ASD).\n* Level I of functioning (able to maintain interaction and adapt to changes).\n* Level II of functioning (able to communicate with others but faces difficulties when changes occur) according to the Autism Spectrum Disorder Social Communication Functioning Classification System.\n\nExclusion Criteria:\n\n* Cognitive limitations\n* Behavioral limitations\n* Clinical limitations (e.g., severe cardiorespiratory disease)",{"count":693,"type":21},52,[73],"Adolescents with Autism Spectrum Disorder (ASD) typically engage less in physical activities than their typically developing peers, influenced by intrinsic and extrinsic factors. Modified sports interventions, like Sports Stars Brazil, can improve motor skills and promote lifelong participation in sports by enhancing physical, social, and cognitive abilities. However, adolescents often face barriers to engaging in community sports and recreational activities after completing the program. PREP is an approach designed to address these barriers by modifying environments and empowering families. To date, no study has explored this combination in adolescents with ASD. Objective: This protocol assesses the effectiveness of combining Sports Stars Brazil with PREP to enhance participation and physical literacy in adolescents with ASD and explores participant and family perceptions. Method: A mixed-methods study with two phases: 1) a randomized controlled trial to investigate combined intervention's effects; and 2) evaluation of participant and family perceptions.",[31],[698,699,700,701,28],"Context-centered intervention","Participation","Adolescents","Modified Sports","2026-03-12",{"date":704,"type":52},"2026-03-13",{"date":706,"type":52},"2025-06-01",{"date":708,"type":21},"2027-06-01",{"name":710,"class":59},"Federal University of Minas Gerais",{"id":712,"slug":713,"hasResults":12,"nctId":714,"briefTitle":715,"officialTitle":716,"acronym":717,"eligibilityCriteria":718,"healthyVolunteers":68,"sex":16,"minAge":17,"maxAge":719,"enrollmentInfo":720,"targetDuration":4,"studyType":22,"phases":721,"briefSummary":723,"conditions":724,"keywords":726,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":732,"lastUpdatePostDateStruct":733,"startDateStruct":735,"completionDateStruct":737,"leadSponsor":738,"locationsCount":60},"100627577","phase-2-role-of-the-gut-vascular-barrier-and-microbiota-in-autism-spectrum-disorders-100627577","NCT07450443","Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders","Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders: Evaluation of Efficacy of Postbiotic-based Nutraceutical Treatment","DSA\u002FGVB","Inclusion Criteria:\n\n* Group 1 and 2:\n\nInclusion criteria\n\n* Diagnosis of ASD according to DSM-5 diagnostic criteria;\n* Clinical neurological evaluation by child neurologist and neuropsychologist with administration of standardized instruments such as Autism Diagnostic Observation Schedule-2 (ADOS-2) and\u002For Autism Diagnostic Interview-Revised (ADI-R) to support diagnosis;\n* Assessment of psychomotor or intellectual development (Griffiths Scales, Wechsler Scales, Leiter Scale)\n* Assessment of the following symptoms in the past three months: constipation, diarrhea, abnormal stool consistency, abnormal stool smell, flatulence, abdominal pain, unexplained daytime irritability, and nighttime awakening, and abdominal tenderness. The degree of gastrointestinal disturbances will be quantified before recruitment using an Italian version of the GI Severity Index. A score of at least 2 in a single item of gastrointestinal symptoms (item 1-6) was required for entry into the symptomatic group.\n* Signed informed consent for analysis of intestinal microbiota and metabolome and administration of nutraceutical therapy with PostbiotiX Comfort ®.\n\nGroup 3 Inclusion criteria\n\n* Males or females aged between 3 and 8 years whit typical development and absence of gastrointestinal symtomps\n* Signed informed consent for analysis of intestinal microbiota and metabolome\n\nExclusion Criteria:\n\nGroup 1 and 2\n\n* Exclusion Criteria\n* Children with syndromic ASD or defined genetic diseases;\n* Subjects with significant health problems requiring surgical treatment or continuous medical; treatment;\n* Severe gastrointestinal problems requiring immediate (life-threatening) treatment;\n* Severely underweight\u002Fmalnourished children;\n* Use of medications that may affect biomarkers assessed, for example: antibiotics and\u002For pre-, probiotics within 1 month prior to enrollment.\n\nGroup 3 exclusion criteria\n\n\\- Participants with gastrointestinal problems requiring immediate (life-threatening) treatment, or with gastrointestinal symptoms such as chronic irregular bowel movements (constipation, diarrhea), encopresis, recurrent abdominal bloating and pain, gastroesophageal reflux and vomiting, or food aversion.","8 Years",{"count":99,"type":21},[25,722],"PHASE3","Recent research links gut microbiota alterations to Autism Spectrum Disorders (ASD), a neurobiological condition with multifactorial bases. In some ASD patients, altered gut flora and increased intestinal permeability are observed, influencing the central nervous system's development and function. Chronic gastrointestinal (GI) symptoms are commonly associated with ASD and correlate with its severity. This non-pharmacological interventional clinical study aims to investigate the role of gut microbiota on ASD and the effectiveness of postbiotic-based dietary supplements in children aged 3-8 years old. Gastrointestinal symptoms, behavioral profile and analysis of intestinal metagenomic and metabolomic profiles will be assessed before and after one-month treatment. The results of the study could enhance understanding of non-pharmacological therapeutic approaches in ASD and improve clinical management strategies and the behavioural functioning for children with ASD.",[29,725,31],"Autism Disorder",[727,728,729,730,731],"Autism Spectrum Disorders (ASD)","Microbiota","Gastrointestinal symptoms","Behaviour regulation","Sensory profile","2026-02-27",{"date":734,"type":52},"2026-03-04",{"date":736,"type":52},"2023-03-21",{"date":120,"type":21},{"name":739,"class":59},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta"]