[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autism":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,116,0,25,[9,61,99,131,165,193,220,250,334,362,384,421,444,469,495,518,540,568,597,620,646,664,692,717,746],{"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":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":12,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100587940","early-phase-1-prednisone-in-adults-with-an-immune-mediated-subtype-of-autism-spectrum-disorder-100587940","NCT06934915","Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder","Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups Trial of Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder","PREDICT","Inclusion Criteria:\n\n1. 18 to 50 years of age (inclusive) and assigned male at birth.\n2. Diagnostic Statistical Manual of Mental Disorders (DSM), Fourth Edition, Text Revision (DSM-IV-TR) diagnosed autistic disorder, and DSM, Fifth Edition, Text Revision (DSM-5-TR) diagnosed autism spectrum disorder (ASD), level 2 or 3. A qualified (board-eligible or board-certified) psychiatrist or psychologist, with experience in diagnostic determinations of ASD, will make a final diagnostic determination based on clinical history, clinical observations, medical records, mental status exams, and screening measures.\n3. A Clinical Global Impression-Severity (CGI-S) rating ≥ 4 (\"Moderate\") at screening (and baseline).\n4. A non-verbal IQ in the range of moderate intellectual disability or higher (≥ 35), as measured by the non-verbal Abbreviated IQ (ABIQ) score of the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), or mental age of at least 18 months, as measured by the Cognitive and Adaptive Behavior subscales of the Developmental Profile (DP-4) Parent\u002FCaregiver Interview form.\n5. Participation of a study partner who has consistent contact with the participant and is willing and able to attend visits, oversee the participant's compliance with the protocol and study medication, and report on the participant's status through study assessments.\n6. Participant reports ≥ 1 of the following:\n\n   * A diagnosed comorbid autoimmune disease (e.g., Crohn's disease, Graves' disease, Hashimoto's disease, psoriasis, rheumatoid arthritis, ulcerative colitis, type 1 diabetes mellitus, etc.).\n   * Current biomarker evidence of critical indicators of inflammation\u002Fautoimmunity, such as elevated levels of C-reactive protein (CRP) or abnormal value of antinuclear antibodies (ANA).\n   * A significant family history of autoimmunity, defined as having ≥ 1 first-degree relative or ≥ 2 second-degree relatives with autoimmune diseases. The Principal Investigator (PI) will make the final determination on this criterion.\n7. Any concomitant medications or interventions for ASD-related symptoms (e.g., alpha-2 agonists, anticonvulsants, antidepressants, antipsychotics, anxiolytics, gastrointestinal medications, medications for sleep disorders, probiotics, stimulants, behavioral therapies, psychosocial interventions, speech therapy, etc.) have been stable for at least 4 weeks prior to the screening visit and the participant\u002Fstudy partner intend to maintain a stable regimen throughout the trial.\n8. Participant can tolerate swallowing large capsules.\n9. Participant is willing and able, in the investigator's opinion, to comply with all study procedures.\n\nIndividuals must satisfy the following criteria to be enrolled as study partners:\n\n1. The study partner is fluent in English.\n2. The study partner is a caregiver or an individual who has consistent contact with the participant, knows the participant well, and is willing and able to attend visits, oversee the participant's compliance with the protocol and study medication, and report on the participant's status through study assessments. The PI will make the final determination on this criterion.\n\nExclusion Criteria:\n\n1. DSM-5-TR diagnosed ASD, level 1, or presence of another DSM-IV-TR diagnosed pervasive developmental disorder, such as Asperger's disorder, childhood disintegrative disorder, Rett syndrome, or pervasive developmental disorder not otherwise specified (PDD-NOS). A qualified psychiatrist or psychologist will make a diagnostic determination after reviewing clinical history, clinical observations, medical records, mental status exams, and screening measures.\n2. A CGI-S rating \\\u003C 4 at screening (or baseline).\n3. A non-verbal IQ in the range of severe or profound intellectual disability (\\\u003C 35), as measured by the non-verbal ABIQ score of the SB-5, or mental age below 18 months, as measured by the Cognitive and Adaptive Behavior subscales of the DP-4 Parent\u002FCaregiver Interview form. Individuals testing below 18 months may be enrolled after a case review by the PI and study psychologist, especially if testing scores were likely underestimated due to uncooperative behavior.\n4. Previous documentation of a prolonged electroencephalogram (EEG) suggestive of Landau-Kleffner syndrome or continuous spike and wave during sleep (CSWS) syndrome.\n5. Presence of a defined genetic disorder, such as Angelman syndrome, Fragile X syndrome, Noonan syndrome, Tuberous sclerosis, Williams syndrome, or any documented chromosomal or genetic abnormality with proven clinical significance in the etiology of ASD.\n6. Documented significant pre- or post-natal central nervous system insult, such as an in-utero cerebral vascular accident, that is believed to have significantly contributed to the development of the individual's ASD.\n7. Mitochondrial disorder verified by skin and\u002For muscle biopsy.\n8. History of bipolar disorder, psychotic disorder or schizophrenia.\n9. History of one or more psychiatric hospitalizations due to symptoms of a major psychiatric disorder (e.g., major depressive disorder, OCD, PTSD, severe anxiety disorders, or substance use disorder). Hospitalization exclusively for irritability or behavioral dysregulation related to ASD, without evidence of a comorbid major psychiatric disorder, is permitted.\n10. Concomitant medications or interventions for ASD-related symptoms (e.g., alpha-2 agonists, anticonvulsants, antidepressants, antipsychotics, anxiolytics, gastrointestinal medications, medications for sleep disorders, probiotics, stimulants, behavioral therapies, psychosocial interventions, speech therapy, etc.) have not been stable for at least 4 weeks prior to the screening visit.\n11. An active bacterial, fungal, helminthic, protozoan, or viral infection that could be exacerbated by a course of prednisone, as determined by the PI.\n12. Significant medical findings from history, physical examination, or laboratory testing that may be incompatible with prednisone use (e.g., participants with chronic infectious conditions or unstable diabetes mellitus, defined as insulin-dependent or HbA1c \\>7.0).\n13. Individuals with a history of seizures being treated with an anticonvulsant may be eligible if seizure-free for at least 6 months and the anticonvulsant dose has been stable for at least 4 weeks prior to the screening visit.\n14. Use of immunosuppressive agents within the 6 months prior to the screening visit or concurrent use of immunosuppressive agents that, in the judgment of the PI, would interfere with study outcomes or pose unreasonable risk with prednisone administration.\n15. A known hypersensitivity to prednisone or any other component of the study product.\n16. The participant is deemed unsuitable for any reason by the PI, including an inability to complete or comply with study requirements.\n\nIndividuals may be excluded from enrollment as study partners if either of the following criteria are met:\n\n1. The study partner is not fluent in English.\n2. The study partner is deemed unsuitable for any reason by the PI, including an inability to complete or comply with study requirements.","MALE","18 Years","50 Years",{"count":73,"type":21},32,[75],"EARLY_PHASE1","The goal of this clinical trial is to learn how prednisone affects adults with autism spectrum disorder (ASD). It will also learn about the safety of prednisone. The main questions it aims to answer are:\n\n* How does prednisone affect the core features and associated target symptoms of ASD in adults with an immune-mediated subtype of ASD?\n* Is prednisone safe for autistic adults without causing too many side effects?\n* Does this study warrant larger trials studying anti-inflammatory drugs in this subject population?\n\nResearchers will compare the drug prednisone to a placebo (a look-alike substance that contains no drug) to see how prednisone affects autistic adult males.\n\nParticipants will:\n\n* Visit the clinic 2 times for a screening and baseline visit.\n* Take prednisone or a placebo every day for 16 weeks.\n* Visit the clinic 2 times for checkups, tests, questionnaires, and dose changes, and 1 time for a follow-up visit 4 weeks after stopping the study drug.\n* Provide blood and urine samples for testing up to 4 times.\n* Complete 8 remote calls every 1-2 weeks for checkups and dose changes.\n* Keep a diary of the dose and times they take the study drug every day and any symptoms or side effects they experience.",[28,78,79,29],"Autism Spectrum Disorders","Autistic Disorder",[28,79,29,81,82,83,84,85,86,87,88],"Autoimmunity","Autoimmune Disorders","Inflammation","Neuroinflammation","Anti-Inflammatory Agents","Corticosteroids","Glucocorticoids","Prednisone","2026-08-18",{"date":91,"type":52},"2026-08-19",{"date":93,"type":52},"2026-08-01",{"date":95,"type":21},"2029-02",{"name":97,"class":59},"Christopher John McDougle, M.D.",1,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":16,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":4,"leadSponsor":128,"locationsCount":98},"100078073","the-neurodevelopmental-and-behavioral-phenotyping-screening-protocol-100078073","NCT00271622","The Neurodevelopmental and Behavioral Phenotyping Screening Protocol","Neurodevelopmental and Behavioral Phenotyping Screening Protocol","* INCLUSION CRITERIA:\n* Subjects must be at least 6 weeks of age.\n* Subjects or their parents must be competent to comprehend the purpose of the screening process and to provide written informed consent. Parents\u002Fguardians will sign the consent form, and both minors and adults (depending on results of capacity assessment) will be asked to assent only if it is determined that they understand their role in the study.\n* Subjects must be willing to undergo an evaluation which may include a psychiatric interview; and medical, neurological, and laboratory examinations (as appropriate, such as renal and liver function tests, serum electrolytes, urinalysis, blood levels of psychotropic drugs, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).\n\nEXCLUSION CRITERIA:\n\n-Lack of appropriate consent: For minor patients, consent must be obtained from all legal guardians\u002Fcaretakers, including both parents in separated or divorced families where there is shared legal custody of the child. In such cases, both parents must consent to the child s participation in this protocol.",true,"6 Weeks",{"count":109,"type":21},5000,"OBSERVATIONAL","The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH....",[113,29,114,115],"Neurologic Disorders","Neurodegenerative Disease","Neurobehavioral Manifestation",[117,118,119,120,121,78,122,123],"Developmental Delay","Pediatric","Pervasive Developmental Disorder","Early Development","Healthy Control Subjects","Healthy Volunteer","HV","2026-08-15",{"date":89,"type":52},{"date":127,"type":52},"2006-02-27",{"name":129,"class":130},"National Institute of Mental Health (NIMH)","NIH",{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":16,"minAge":70,"maxAge":71,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":98},"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.",{"count":139,"type":21},90,[141],"NA","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.",[144,29,145],"Autism Spectrum Disorder (ASD","Autistic Spectrum Disorder (ASD)",[147,30,148,149,150,151,152,153,154,155],"Autism spectrum disorder","autism","psychosocial intervention","social participation","community-based intervention","cultural participation","autistic adults","social prescribing","museum-based intervention","2026-08-13",{"date":158,"type":52},"2026-08-17",{"date":160,"type":52},"2024-05-01",{"date":162,"type":21},"2027-12",{"name":164,"class":59},"National Taiwan University Hospital",{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":16,"minAge":172,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":98},"100545755","the-power-down-pilot-study-a-novel-bedtime-manipulation-protocol-100545755","NCT06386029","The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol","Powering Down: A Pilot Study of a Bedtime Manipulation to Support Sleep for Autistic Children","Inclusion Criteria:\n\n1. Child between the ages of 6 and 10 years old (at least 40%, no more than 60% female)\n2. Parent-reported autism diagnosis for child\n3. Parent-reported extended and problematic settling down delay\n4. Parent-reported sensory over-responsivity (a \"yes\" to at least 8 items in the sensory screening section of the checklist)\n5. Parent willing to participate in nightly routine during the 2 week study\n6. Located within the Pittsburgh area\n\nExclusion Criteria:\n\n1. Participants will be excluded if they do not understand English or are unable to travel to University of Pittsburgh Medical Center Western Psychiatric Hospital.\n2. Children who have trauma or other histories for whom physical touch is triggering (per caregiver report) will be excluded.\n3. If a child spends bedtime at a different caregiver's home for \\>50% of the nights and that caregiver is not willing to participate in this study, the child will be excluded from this study.","6 Years","10 Years",{"count":175,"type":21},10,[141],"The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called \"The Power Down\" for autistic youth, ages 6-10. The main questions it aims to answer are:\n\n1. Is the Power Down feasible for caregivers to do each night?\n2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?",[29,179],"Sleep Disturbance",[181,182,183],"Sleep disturbances","Emotion Dysregulation","Sensory Processing","2026-08-12",{"date":186,"type":52},"2026-08-14",{"date":188,"type":52},"2025-07-05",{"date":190,"type":21},"2026-12",{"name":192,"class":59},"University of Pittsburgh",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":16,"minAge":200,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":98},"100651786","eye-tracking-and-autism-in-former-preterm-infants-100651786","NCT07764822","Eye Tracking and Autism in Former Preterm Infants","Eye-Tracking Biomarkers for Early Autism Detection in Former Preterm Infants","Inclusion Criteria:\n\n* Children born at \\\u003C37 weeks' gestational age who are 14-48 months old at time of referral\n* Ambulatory (i.e., cruising, walking)\n* Without significant visual impairment\n* Referred for autism testing through EYP (i.e. medium- or high-risk M-CHAT-R\u002FF screening result at 16-22 months corrected age or by referral to Early Years based on caregiver or provider concern for autism)\n\nExclusion Criteria:\n\n* Non-English-speaking participants and families.","14 Months","48 Months",{"count":203,"type":21},40,[141],"This is a single center, intervention study of integrating the eye-tracking (ET) biomarker battery into the existing autism evaluation process at the Riley Early Years Program (EYP). Eligible participants referred for autism testing through EYP will undergo a traditional comprehensive diagnostic assessment by an EYP clinical psychologist.",[29,207],"Prematurity",[148,209,210],"prematurity","eye tracking biomarkers","NOT_YET_RECRUITING","2026-08-10",{"date":186,"type":52},{"date":215,"type":21},"2027-01-04",{"date":217,"type":21},"2028-01-03",{"name":219,"class":59},"Indiana University",{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":16,"minAge":70,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":98},"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":203,"type":21},[141],"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],[29,233,234,235,236,237,238,239,240,241,242],"Autistic adults","Neurodiversity","Neurodivergent","Dance","Yoga","Mindful","Social communication","Well-being","Lifestyle intervention","Adaptive movement",{"date":184,"type":52},{"date":245,"type":21},"2027-01-17",{"date":247,"type":21},"2027-04-04",{"name":249,"class":59},"USC Glorya Kaufman School of Dance",{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":106,"sex":16,"minAge":258,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":307,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":330,"leadSponsor":332,"locationsCount":98},"100641475","qaiax-aihealth4u---ai-public-health-central-microcity-a-re-quantum-ai-agency-aka-ai-city-hall-project-upsto-app-nos-64074526-64063557-63903181-63729428-100641475","NCT07661823","QAIAx (AIhealth4U) - AI Public Health Central: Microcity-A (re Quantum AI Agency Aka AI City Hall Project, UPSTO App Nos. 64\u002F074,526, 64\u002F063,557, 63\u002F903,181, 63\u002F729,428","QAIAx (AIhealth4U) - AI Public Health Central: Microcity-A (re Quantum AI Agency Aka AI City Hall Project, UPSTO App No(s). 64\u002F105,164, 64\u002F074,526, 64\u002F063,557, 63\u002F903,181, 63\u002F729,428: A Quantum AI Public Health Agency That Provides Free Public Health Services to Registered and Sponsored Visitors\u002FOccupants for RDT&E Under 28 U.S. Code 1498 (Classified as a PPA Under 10 U.S. Code 129a)","QAIAx","Inclusion Criteria:\n\n* Individuals aged 17 to 99 years old.\n* Referral by a licensed health services professional (e.g., R.N., N.P., Ph.D., M.D.).\n* Referral by a non-profit organization (e.g., 501c3, university, church).\n* Referral by a public agency (e.g., case manager, social worker, parole\u002Fprobation\u002FPTS officer, judge).\n\nExclusion Criteria:\n\n\\* Individuals under 17 or over 99 years of age.","17 Years","99 Years",{"count":261,"type":21},1000000,[141],"BRIEF SUMMARY\n\nA. \"What is the purpose of this study?\"\n\nThis study will test whether the \"AI City Hall Project\" (QAIAx), a quantum artificial intelligence (AI) public health agency, can provide free or low-cost behavioral and mental health services inside self-contained, dome-enclosed communities called \"Microcities\". Researchers want to see if AI-managed public administration, AI humanoid robots, holoportation of human-figures via 'holo-suites' (e.g., AI-119 Kikkeri Holo-Suit; AI-119 Vulcan QM-Ware) and advanced AI mental-health tools can lower housing and care costs, improve mental health outcomes (e.g., particular ecosystems using AI tools among persons with one or more addiction disorders), and be financially sustainable for people on fixed incomes or public assistance.\n\nB. \"What conditions does the study focus on?\"\n\nThe study focuses on adults with:\n\n* Autism spectrum disorders (Asperger's, autism, ADHD, ASD)\n* Substance use disorders (alcohol, opioids, marijuana, cocaine, MDMA\u002Fecstasy, tobacco\u002Fnicotine)\n* Psychiatric conditions (personality disorders, narcissism, gender dysphoria, eating disorders)\n* Behavioral addictions (gambling, sex addiction) and related issues (sex offence history).\n\nC. \"What does the study involve?\"\n\nEligible volunteers live in an omni AI-managed Microcity for up to 24 months. The community is housed in a geodesic dome that contains all daily necessities: housing, food, utilities, healthcare, and public services. Daily life is managed by an AI system (ISAC) and AI humanoid robots, with only occasional human oversight. Participants receive free mental-health treatment that may include AI-driven counselling, virtual-reality therapy (holo-suits), and non-invasive digital \"attitude inoculation\" protocols designed to reduce stress and addiction cravings. All participants also take AI-technology courses as a condition of enrolment. The study does not use any FDA-regulated drug, device, or biologic.\n\n\\*\\*Who can participate?\\*\\*\n\nYou may be able to join if you:\n\n* Are an adult (18 years or older)\n* Have a diagnosis of one of the listed mental-health or addiction disorders\n* Are referred by a licensed health professional (e.g., RN, NP, PhD, MD), a non-profit organisation (e.g., 501(c)(3), university, church), or a public agency (e.g., case manager, social worker, parole\u002Fprobation officer, judge)\n* Are willing to live in a closed, AI-managed community for up to one year and complete AI educational courses.\n\nParticipants who are veterans, receive public assistance (e.g., VA disability, SSDI\u002FSSI, Medicaid, Medicare), or are experiencing homelessness may be prioritised.\n\n\\*\\*Where is the study taking place?\\*\\* The study will be conducted at Microcity sites in the United States and internationally. The first administrative site is in Richmond, Virginia, USA. Additional sites are planned in partner nations, including tribal lands, military installations, and special economic zones.\n\n\\*\\*Who is sponsoring the study?\\*\\* The study is sponsored by \\*\\*Veterans Recovery Network Inc.\\*\\*, a non-profit organization, in collaboration with \\*\\*AI-119 Vulcan Project Research \\& Educational Technology Co. (PRETCO)\\*\\* and an AI legal agency. The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §129a) and is part of a Cooperative Research and Development Agreement (CRADA) with U.S. Special Operations Command (USSOCOM).\n\nThis summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.",[265,266,267,29,268,269,30,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306],"Asperger's Disorder","Asperger Disorder","Autism Disorder","ADHD - Attention Deficit Disorder With Hyperactivity","ADHD","Alcohol Abuse\u002FDependence","Alcohol Addiction","Alcohol and Other Drug Use Disorders","Alcohol and Other Substance Use Prevention","Gambling Addiction","Gambling Disorder","Sex Abuse","Sex Behavior","Sex Crimes","Sex Disorder","Sex Disorders","Gender Dysphoria, Adult","Eating Behavior Disorders","Narcotic-Related Disorders","Narcotic Addiction","Narcissism","Psychiatric Disorder","Psychedelic Effects in Healthy Volunteers","Psychedelic Experiences","Psychedelic Drug Dependence","Marijuana Use Disorder","Marijuana Abuse and Dependence","Smoking (Tobacco) Addiction","Smoking Among Youth","Smoking Abstinence","Abstinence, Sex","Opiate Substitution Treatment","Opioid Abuse (Disorder)","Opioid Abuse and Addiction","Cocaine Abuse","MDMA ('Ecstasy')","Addiction Disorders","Homeless and Low Incomes People, Refugees","Homelessness","Reliability and Validity","Anger Problems","Child Abuse, Sexual",[308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327],"ai city hall project","ai 119","ai119","qaia","qaiax","ai wat","veterans recovery network","veterans","addiction disorder","vulcan","artificial intelligence","agi","military","sex addiction","mental health treatment","smart health cities","microcities","smartcities","smart city","omni ai",{"date":184,"type":52},{"date":93,"type":21},{"date":331,"type":21},"2028-12-31",{"name":333,"class":59},"Veterans Recovery Network Inc.",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":4},"100650635","testing-a-blended-social-communication-and-social-emotional-intervention-for-autistic-toddlers-100650635","NCT07748780","Testing a Blended Social-Communication and Social-Emotional Intervention for Autistic Toddlers","BALANCED","\\\u003CChild Participant\\>\n\nInclusion Criteria:\n\n* Under 36 months of age at enrollment.\n* Has a clinical diagnosis of autism.\n* Is currently receiving services through Part C Early Intervention (EI).\n* Able to participate in natural caregiver-child routines and play activities.\n\nExclusion Criteria:\n\n* Has a co-occurring medical condition (e.g., uncontrolled seizures, significant sensory or motor impairment) that would prevent participation in caregiver-child interaction sessions.\n* Not currently eligible for or receiving Part C services.\n* Previously participated in pilot testing of the blended intervention.\n\n\\\u003CCaregiver Participant\\>\n\nInclusion Criteria:\n\n* At least one primary caregiver is available and willing to participate in weekly coaching sessions for 12 weeks.\n* Caregiver agrees to participate in baseline, post-intervention, and follow-up assessments.\n* Caregiver consents to allow video recording of some sessions for fidelity monitoring and research purposes.\n* Caregiver has sufficient English proficiency to engage in intervention and assessment procedures (Spanish adaptation to follow in future phases).\n\nExclusion Criteria\n\n* Unable to commit to the 12-week intervention schedule or 3-month follow-up.\n* Does not consent to video recording required for fidelity monitoring.\n* Insufficient English proficiency for participation in intervention sessions at this time.",{"count":203,"type":21},[141],"Autistic toddlers often need support to develop both social-communication and social-emotional skills. Social communication (such as making requests or sharing attention) is usually addressed in early intervention, but social-emotional needs (such as expressing feelings or learning to cope with frustration) are often overlooked. Both are important for children's development and for preventing challenging behaviors.\n\nThis study is testing a blended intervention designed to support both areas at the same time. The program combines Project ImPACT, a caregiver-mediated social communication intervention, with universal practices from the Pyramid Model, a national framework for promoting young children's social-emotional development.\n\nCaregivers of autistic toddlers will be coached by early intervention providers to use strategies during everyday routines and play. The study will enroll 40 caregiver-toddler pairs, randomly assigning them to one of four study conditions. Families assigned to the waitlist control group will receive the intervention after a delay.\n\nThe goal is to understand whether this blended approach improves toddlers' communication and emotional development, and whether caregivers find it helpful and practical in daily life. Because many states and early intervention systems already use the Pyramid Model, this study could provide a way to make those programs more inclusive of autistic children and their families.",[29,345],"Social Emotional Development Delays",[29,347,348,349,350,351,352],"Social Communication","Social Emotional","Early Intervention","Project ImPACT","Pyramid Model","Community-Partnered Research","2026-07-31",{"date":355,"type":52},"2026-08-06",{"date":357,"type":21},"2026-09-01",{"date":359,"type":21},"2027-12-31",{"name":361,"class":59},"Baylor University",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":16,"minAge":368,"maxAge":172,"enrollmentInfo":369,"targetDuration":4,"studyType":22,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":382,"locationsCount":60},"100609547","phase-2-role-of-omega-dek-in-childhood-apraxia-of-speech-100609547","NCT07216001","Role of Omega-DEK in Childhood Apraxia of Speech","Inclusion Criteria for Main Trial:\n\n1. Confirmed diagnosis of childhood apraxia of speech\u002Fverbal apraxia by a qualified professional (SLP) based on established guidelines\n2. Male and female, age 36 months - 6 years (inclusive)\n3. Ability to comprehend and use Standard American English\n\nExclusion Criteria for Main Trial:\n\n1. Children unable to tolerate oral supplementation\n2. Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug\n3. Medical or genetic condition that in the opinion of the PI\u002FCo-Is may affect participation and compromise results (including significant receptive language delay, moderate-severe cognitive delay, complex medical history, hearing loss, cerebral palsy, history of traumatic brain injury or severe anoxic event, Down's syndrome)\n4. Known seizure disorder or history of febrile seizures\n5. History of cardiac dysrhythmia or abnormal ECG at baseline\n6. A prothrombin time test with an international normalised ratio (PT\u002FINR) \\>1.2\n7. Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc.\n8. A history of PUFA or vit E supplementation use within 3 months prior to enrollment in the study\n9. On an elimination diet for \\\u003C 3 months (gluten, casein, yeast free etc.) prior to enrollment, or planning to initiate a special diet during the study\n10. Recent reintroduction of food items from elimination diet \\\u003C 3 months\n11. On any additional nutritional interventions\u002Fsupplements \\\u003C 3 months (i.e. high dose vitamins\u002Fminerals that exceed what would be found in a children's multivitamin supplement etc., probiotics)\n12. Any new chronic medication \\\u003C 3 months prior to enrollment (stable doses \\> 3 months allowed; medications for acute illness allowed including antipyretics, antibiotics, asthma medication)\n13. Anticipated initiation of new chronic medication during study timeline including new attention-deficit\u002Fhyperactivity disorder (ADHD) medications, other behavior medications\n14. Plans to try additional complementary interventions or diets during the study period\n15. Planned surgery during or within 4 weeks after conclusion of trial\n\nInclusion Criteria for Expanded Cohort:\n\n1. Working Diagnosis of CAS, or intestinal lymphangiectasia, or fat malabsorption syndrome (in isolation or associated with other medical conditions such as cystic fibrosis, celiac disease, etc.)\n2. Male and female, aged ≥2 years\n3. Ability to comprehend and use Standard American English\n\nExclusion Criteria for Expanded Cohort:\n\n1. Subjects unable to tolerate oral supplementation\n2. Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug\n3. History of cardiac dysrhythmia or abnormal ECG at baseline\n4. PT-INR \\>1.2. A clinical lab performed within a month of enrollment will be accepted to meet this exclusion criteria\n5. Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc. (Symptomatic use of NSAIDS for acute fever or pain permitted)","36 Months",{"count":370,"type":21},34,[25],"This is a 20-week study for children between 3 and 6 years old with confirmed childhood apraxia of speech (CAS). The study includes a 12-week open-label pilot feasibility study of an investigational drug (Omega-DEK) plus L-carnitine (Carnitor®), which is followed by an 8-week randomized, placebo-controlled discontinuation period among the same study participants.",[374,375,29],"Childhood Apraxia of Speech","Verbal Apraxia","2026-07-27",{"date":378,"type":52},"2026-07-29",{"date":380,"type":21},"2026-11",{"date":162,"type":21},{"name":383,"class":59},"Claudia R. Morris",{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":16,"minAge":392,"maxAge":258,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":420},"100522340","phase-2-sertraline-vs-placebo-in-the-treatment-of-anxiety-in-children-and-adolescents-with-neurodevelopmental-disorders-100522340","NCT06081348","Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders","A Randomized Placebo-Controlled Trial of Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders","CALM","Inclusion Criteria:\n\n1. Outpatients 8-17 years of age, inclusive\n2. Females of child bearing potential who are sexually active and agree to use medically acceptable birth control throughout the study and at least one week post last dose of study drug.\n3. Meet Diagnostic and Statistical Manual of Mental Disorders - DSM-5 criteria for ASD, ADHD, Tic Disorders, or genetic diagnosis of Fragile X, tuberous sclerosis or 22q11 deletions.\n4. Meet DSM-5 criteria for one of the following anxiety disorders: Separation Anxiety Disorder, Social Anxiety Disorder, Agoraphobia, Generalized Anxiety Disorder, or Unspecified Anxiety Disorder, based on expert clinical interview, supported by the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS; Kaufman et al., 2016). Other specified anxiety disorder is included to account for youth with impairing anxiety symptoms who may not meet criteria for one of the other anxiety disorders.\n5. Have a Clinician's Global Impression-Severity for anxiety (CGI-S; Guy, 1976)) score ≥ 4 (moderately ill) (inter-rater reliability will be done prior to initiation of enrollment, using videotapes of interviews and vignettes)\n6. If already receiving interventions, must meet the following criteria:\n\n   1. If receiving concomitant medications affecting behaviour, must be on a stable dose during the month prior to screening and will not electively modify ongoing medications for study duration\n   2. If already receiving stable non-pharmacological behavioural interventions, have stable participation during 3 months prior to screening, and will not electively modify ongoing interventions\n7. Ability to complete assessments in English\n\nExclusion Criteria:\n\n1. Receiving other SSRIs within four weeks of randomization (6 weeks for fluoxetine)\n2. Previous treatment with sertraline, at an adequate dose (at least 100mg for 6 weeks, or lower dose and duration if not well-tolerated), associated with no response or significant-to-the-participant side effects.\n3. Received more than 2 previous appropriate trials of SSRIs with no adequate response\n4. Pregnant females or sexually active females on inadequate contraception\n5. Serious medical condition that, based on Investigator judgment, might interfere with the conduct of the study, confound interpretation of the study results, or endanger participant. In addition diabetic patients on medications for glycemic control will be excluded as sertraline may interfere with glycemic control.\n6. Hypersensitivity to sertraline or any components of its formulation\n7. On Monoamine Oxidase Inhibitors or pimozide (as per product monograph)\n8. On concomitant medications known to significantly increase QT interval where this would result in unacceptable risk per Investigator judgment.\n9. Known congenital QT prolongation\n10. HIV, hepatitis B or C, hemophilia, abnormal blood pressure, substance abuse, immunity disorder, major depressive episode or psychosis (as required by Health Canada)\n11. Unable to tolerate venipuncture\n12. Unable to swallow capsules\n13. Enrolled in another intervention study","8 Years",{"count":394,"type":21},130,[25],"There are currently no approved medications for the treatment of anxiety in children and youth with neurodevelopmental disorders (NDDs), both common and rare. Sertraline, a selective serotonin reuptake inhibitor, has extensive evidence to support its use in children's and youth with anxiety but not within NDDs. More research is needed to confirm whether or not sertraline could help improve anxiety in children and youth with common and rare neurodevelopmental conditions. This is a pilot study, in which we plan to estimate the effect size of reduction in anxiety of sertraline vs. placebo. across rare and common neurodevelopmental disorders, and determine the best measure(s) to be used as a primary transdiagnostic outcome measure of anxiety, as well as diagnosis specific measures in future, larger-scale clinical trials of anxiety in NDDs.",[398,29,28,399,400,401,402,269,403,404,405,406,407,408,409,410,411],"Neurodevelopmental Disorders","Fragile X Syndrome","Tuberous Sclerosis","22Q11 Deletion Syndrome","22Q11 Deletion","Tic Disorders","Tourette Syndrome","Tourette Syndrome in Children","Tourette Syndrome in Adolescence","ADHD - Combined Type","ADHD Predominantly Inattentive Type","ADHD, Predominantly Hyperactive - Impulsive","Anxiety","Anxiety Disorders","2026-07-24",{"date":376,"type":52},{"date":415,"type":52},"2024-09-16",{"date":417,"type":21},"2027-09",{"name":419,"class":59},"Holland Bloorview Kids Rehabilitation Hospital",7,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":16,"minAge":172,"maxAge":173,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":431,"briefSummary":432,"conditions":433,"keywords":436,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":441,"leadSponsor":443,"locationsCount":98},"100629612","differences-in-rest-emotion-and-arousal-modulation-in-youth-100629612","NCT07476937","Differences in Rest, Emotion, and Arousal Modulation in Youth","Probing the Role of Sensory Regulation in Sleep Health and Emotion Dysregulation for Autistic Youth","DREAMY-Autism","Inclusion Criteria:\n\n1. Youth between the ages of 6 and 10 years old\n2. Caregiver-reported autism diagnosis and \\>11 on Social Communication Questionnaire\n3. Caregiver-reported bedtime resistance (\\>12 on Children's Sleep Habits Questionnaire-Autism; Sleep Initiation subscale - 3-point scale, 6 questions)\n4. Caregiver willing to participate in all bedtimes during study\n5. Stable medication use (e.g., no changes within 2 weeks)\n\nExclusion Criteria:\n\n1. Participants will be excluded if they do not understand English or are unable to travel to the lab (Pittsburgh, PA).\n2. Concurrent diagnosis of sleep apnea, narcolepsy, or major psychiatric disorder (e.g., major depression, bipolar).\n3. Unstable medication use (dose or timing).\n4. Current behavioral treatment for sleep disorder",{"count":430,"type":21},60,[141],"The goal of this study is to examine the relationship between sensory responsivity, bedtime arousal levels, sleep disturbances, and daytime emotion dysregulation for autistic children (ages 6-10). In a subset of children with elevated sensory responsivity, a sensory-based bedtime manipulation targeting bedtime arousal levels will be tested.",[29,434,435],"Sleep Disturbances in Children","Sleep",[181,182,183,435,148],"2026-07-20",{"date":439,"type":52},"2026-07-22",{"date":437,"type":52},{"date":442,"type":21},"2030-08",{"name":192,"class":59},{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":16,"minAge":452,"maxAge":392,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":98},"100647283","parent-mediated-social-cognition-intervention-for-young-children-with-autism-spectrum-disorder-100647283","NCT07708246","Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder","Efficacy of a Parent-Mediated, Home-Based Structured Play Intervention on Social Cognitive Development in Young Children With Autism Spectrum Disorder: A Non-Randomized Controlled Study","PMSC-ASD","Inclusion Criteria:\n\nChildren：\n\n* Aged 2.5 to 14 years at time of enrollment, with a primary recruitment focus on children aged 3 to 10 years.\n* Meets diagnostic criteria for autism spectrum disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a specialist clinician.\n* Full-scale intelligence quotient (FSIQ) ≥ 70 as assessed by an age-appropriate Wechsler intelligence scale administered.\n* Possesses sufficient verbal ability to engage with structured play-based intervention activities, as judged by the recruiting clinician.\n* Resides with and is cared for by a participating parent or legal guardian who meets the caregiver eligibility criteria below.\n\nCaregiver：\n\n* Is the primary caregiver (parent or legal guardian) of the enrolled child and resides in the same household.\n* Is able and willing to attend an in-person parent training session (approximately 2.5 hours) at the study site prior to intervention commencement.\n* Is able and willing to commit to administering the structured intervention program to the child for a minimum of 30 minutes per day throughout the 6-month intervention period.\n* Is able and willing to participate in monthly online video supervision sessions with the study clinician.\n* Has sufficient literacy and comprehension ability to understand program training materials and follow intervention procedures.\n* Provides written informed consent on behalf of the child and for their own participation prior to any study procedures.\n\nExclusion Criteria:\n\nChildren：\n\n* Known diagnosis of a genetic syndrome associated with ASD or intellectual disability, including but not limited to Fragile X syndrome, Down syndrome, tuberous sclerosis complex, or Rett syndrome.\n* Presence of a neurological disorder, including epilepsy (unless fully controlled with stable medication for ≥ 12 months), acquired brain injury, cerebral palsy, or other significant neurological condition that may confound assessment of social cognition.\n* Uncorrected vision or hearing impairment that would preclude participation in behavioral or eye-tracking assessments.\n* Currently enrolled in another interventional clinical study targeting social cognition, communication, or behavioral outcomes.\n* Any medical, psychiatric, or developmental condition that, in the opinion of the recruiting clinician, would interfere with the child's ability to participate in or benefit from the intervention.\n\nCaregiver：\n\n* Unable to attend the in-person parent training session at the study site due to geographic, occupational, or other constraints.\n* Unable to commit to the daily home-based intervention schedule or monthly online supervision sessions for the full 6-month intervention period.\n* Presence of significant mental health difficulties or other circumstances that, in the opinion of the recruiting clinician, would substantially impair the caregiver's ability to deliver the intervention with adequate fidelity.","4 Years",{"count":430,"type":21},[141],"This study evaluates the efficacy of the Companion Mind-Drawing Cooperative Game Program, a parent-mediated, home-based structured play intervention targeting social cognitive development in young children with autism spectrum disorder (ASD).\n\nChildren with ASD in the intervention group will receive a structured program in which parents attend an in-person training session (approximately 2.5 hours) at the hospital, where parents are taught to administer a series of researcher-designed cooperative game paradigms at home. Parents then deliver the intervention daily for at least 30 minutes per session over a period of six months. Monthly online video reviews by a clinician provide parents with individualized feedback and guidance to ensure program fidelity and quality.\n\nChildren with ASD in the comparison group will continue to receive usual care and will not receive the program during the study period.\n\nSocial cognitive outcomes - including emotion recognition, theory of mind, empathy, joint attention, self-perception, and social communication - will be assessed at baseline and at 12-month follow-up using behavioral experimental tasks and eye-tracking paradigms. This study aims to provide evidence for the efficacy of a scalable, family-implemented social cognition intervention for young children with ASD.",[29,457,458,459],"Intervention (Training) Condition","Social Cognition","Cognition Improvement","2026-07-13",{"date":462,"type":52},"2026-07-16",{"date":464,"type":52},"2025-06-01",{"date":466,"type":21},"2028-12-30",{"name":468,"class":59},"Children's Hospital of Fudan University",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":16,"minAge":476,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":479,"briefSummary":480,"conditions":481,"keywords":482,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":98},"100631414","improving-caregiver-engagement-in-early-interventions-100631414","NCT07500363","Improving Caregiver Engagement in Early Interventions","Improving Caregiver Engagement in Early Interventions for Autistic Children Using a Mobile Health Approach","Providers' eligibility criteria\n\n1. currently providing early intervention services, including a caregiver-coaching component\n2. having at least 1 child in the autism service classification on their caseload.\n\nCaregiver\u002FChild Dyads eligibility criteria\n\n1. child is 12-60 months of age at the time of enrollment\n2. child has a diagnosis or high likelihood of autism\n3. a family\u002Ffriend supporter of the caregiver is willing to be part of the study\n4. caregivers and supporters speak English","12 Months",{"count":478,"type":21},28,[141],"The goal of this study is to test the effectiveness of the FANS-EI program in supporting caregiver engagement in caregiver-mediated early interventions for young children with autism. This study also examines caregiver-perceived social support and self-efficacy and FANS-EI implementation outcomes (feasibility, acceptability, appropriateness).",[29],[349,483,484,485,486],"Caregiver Mediated Interventions","caregiver engagement","mobile health","social support",{"date":488,"type":52},"2026-07-15",{"date":490,"type":52},"2026-03-25",{"date":492,"type":21},"2028-12",{"name":494,"class":59},"University of California, Davis",{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":106,"sex":16,"minAge":476,"maxAge":368,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":503,"briefSummary":504,"conditions":505,"keywords":506,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":98},"100629201","family-centered-implementation-of-parent-training-for-autistic-toddlers-in-early-intervention-100629201","NCT07471594","Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention","Family-Centered Implementation of Parent Training for Emotion Regulation in Autistic Toddlers Within the Part C Early Intervention System","The following is a list of inclusion and exclusion criteria by participant group across all three research aims.\n\nInclusion Criteria for All Participants:\n\n* Able to provide written and informed consent;\n* Both sexes and all racial and ethnic origins;\n* English fluency (necessary for informed consent and measure completion)\n\nInclusion Criteria for Providers:\n\n* Is between 18 and 75 years of age\n* Holds a contract with or formally employed by BabyNet\n* Provides services within BabyNet at least one half-hour per week\n* Provides therapeutic services within BabyNet to at least one child 12-36 months who is 1) at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI, and 2) has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.\n\nExclusion Criteria for Providers:\n\n* Not contracted or employed by BabyNet\n* Provides services less than one half-hour per week\n* Does not provide services to a child 12-36 months of age at high-likelihood for ASD and with elevated emotion dysregulation (based on the POSI and the EDI-YC)\n\nInclusion Criteria for Caregiver in Caregiver-Child Dyad:\n\n* Is between 18 and 75 years of age\n* Is the legal guardian of the participating child\n* Child is receiving services within BabyNet at least one half-hour per week - Caregiver participates or is present for BabyNet services\n\nExclusion Criteria for Caregiver in Caregiver-Child Dyad:\n\n* Not between 18 and 75 years of age\n* Not the legal guardian of the child\n* Not able to be present for BabyNet services\n\nInclusion Criteria for Children in Caregiver-Child Dyad:\n\n* Is between 12 and 36 months of age\n* Is enrolled in BabyNet services at least one half-hour per week\n* Is considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI\n* Has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.\n\nExclusion Criteria for Children in Caregiver-Child Dyad:\n\n* Is not between 12 and 36 months of age\n* Is not receiving services in BabyNet at least one half-hour per week\n* Is not considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI\n* Does not have elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.",{"count":203,"type":21},[141],"Early Intervention (EI) systems are ill-equipped to serve the many children 12 to 36 months with early signs or a diagnosis of autism spectrum disorder (ASD). EI funded by Part C of the Individuals with Disabilities Education Act (IDEA) uses home-based service delivery, emphasizes family-centered care, and prioritizes family-defined concerns (i.e., patient-centered outcomes). The Part C system is ideally situated to provide family-based intervention to children aged birth to three. However, Part C EI providers receive little training in ASD or the challenges characterizing ASD in toddlerhood, most notably emotion regulation. This study introduces Parent Training for emotion regulation for autistic toddlers into the Part C EI system, determines its feasibility and preliminary efficacy in this setting, and assesses what family, provider, and system-level factors may facilitate the uptake of parent training in the Part C EI system.",[29],[507,508],"emotion regulation","early intervention","2026-07-10",{"date":511,"type":52},"2026-07-14",{"date":513,"type":52},"2026-03-01",{"date":515,"type":21},"2027-10-31",{"name":517,"class":59},"University of South Carolina",{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":16,"minAge":525,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":22,"phases":528,"briefSummary":529,"conditions":530,"keywords":532,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":538,"locationsCount":60},"100634425","a-toolkit-to-improve-mental-health-treatment-for-autistic-individuals-100634425","NCT07539519","A Toolkit to Improve Mental Health Treatment for Autistic Individuals","A Transdiagnostic Toolkit to Improve Mental Health Treatment for Autistic Individuals","The following describes Phase II (the clinical trial):\n\nInclusion Criteria for clients:\n\n* A confirmed diagnosis of autism\n* Between 13 and 17 years old\n* Fluent in English\n* Have a co-occurring mental health condition that is appropriate for treatment at the community clinic participating in the proposed study\n\nExclusion criteria:\n\nN\u002FA\n\nAll therapists working at the community clinic at which this study takes place will be eligible to participate.","13 Years",{"count":527,"type":21},18,[141],"This pilot study is funded by the Organization for Autism Research (OAR). We are conducting a pilot study to improve mental health treatment for autistic individuals. First, we will conduct remote focus groups to identify barriers to mental health treatment and methods to improve treatment. Based on results, we will develop a prototype of a resource for therapists. This resource will be pilot tested in a community clinic.",[29,531],"Mental Health Conditions",[322],"2026-07-08",{"date":509,"type":52},{"date":536,"type":52},"2026-04-09",{"date":162,"type":21},{"name":539,"class":59},"Florida International University",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":16,"minAge":547,"maxAge":452,"enrollmentInfo":548,"targetDuration":4,"studyType":22,"phases":550,"briefSummary":551,"conditions":552,"keywords":553,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":98},"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",{"count":549,"type":21},140,[141],"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],[29,28,554,555,349,556,557,120,558,559],"Early Start Denver Model (ESDM)","Pivotal Response Treatment (PRT)","Naturalistic Developmental Behavioral Intervention (NDBI)","Communication","Parents","Language","2026-07-06",{"date":533,"type":52},{"date":563,"type":21},"2027-01",{"date":565,"type":21},"2037-01",{"name":567,"class":59},"Stanford University",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":16,"minAge":575,"maxAge":576,"enrollmentInfo":577,"targetDuration":4,"studyType":22,"phases":578,"briefSummary":579,"conditions":580,"keywords":584,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":4},"100644755","a-two-part-intervention-to-target-cardiovascular-health-100644755","NCT07673172","A Two-Part Intervention to Target Cardiovascular Health","Autism Research Consortium on Physical Health: A Two-Part Intervention to Target Cardiovascular Health","Inclusion Criteria:\n\n* • Have a diagnosis of autism or be told by a healthcare provider that you have autism\n\n  * Be between the ages of 9 and 26\n  * Have a BMI greater than the 84th percentile\n  * English speaking\n\nExclusion Criteria:\n\n* • Children younger than 9 years of age\n\n  * Adults older than 26 years of age\n  * Individuals without a diagnosis of autism\n  * Individuals with a BMI less than the 84th percentile","9 Years","26 Years",{"count":394,"type":21},[141],"Obesity is one of the most common health conditions among autistic young people and its prevalence rises at faster rates for autistic-relative to non-autistic-individuals. This places them at heightened risk for cardiovascular disease (CVD) and mortality before they enter adulthood. Studies have identified three key contributing factors to CVD outcomes in autistic individuals: unhealthy lifestyle behaviors, Adverse Childhood Experiences (ACEs), and chronic stress.\n\nThis study will explore the effectiveness of two CVD-focused primary care interventions for autistic individuals (ages 9-26): (1) lifestyle medicine consultations tailored towards supporting health-promoting behaviors; and (2) a Cognitive Behavioral Therapy (CBT) intervention tailored towards addressing chronic stress that contributes to excess weight and maladaptive eating behaviors and results in obesity and CVD. Participants and their caregivers will be randomly placed into either the Lifestyle Medicine Group, CBT Group, or combined Lifestyle Medicine with CBT Group. Participants will respond to questionnaires and surveys measuring lifestyle habits, stress, and psychological risk factors at their first visit, 6-month visit, and 3 months post-intervention visit. Over the course of 6 months, participants will attend virtual sessions (up to three times a month) in accordance with their intervention group.",[29,581,582,583],"Adverse Childhood Experience","Stress","Cardiovascular (CV) Risk",[148,585,586,587],"adverse childhood experiences","stress","cardiovascular risk","2026-06-22",{"date":590,"type":52},"2026-06-29",{"date":592,"type":21},"2026-07-01",{"date":594,"type":21},"2028-08-31",{"name":596,"class":59},"University of California, Los Angeles",{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":106,"sex":16,"minAge":452,"maxAge":258,"enrollmentInfo":604,"targetDuration":4,"studyType":22,"phases":606,"briefSummary":607,"conditions":608,"keywords":610,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":98},"100543965","modified-pivotal-response-treatment-for-insistence-on-sameness-in-autistic-youth-100543965","NCT06362733","Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth","M-PRT-IS","Participants will include children with:\n\n1. parent\u002Fguardian aged 18 years or older with a child aged between 4.0 to 17.11 years old at the time of parental consent;\n2. diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., ADOS) or suspicion of ASD diagnosis and confirmed with Autism Diagnostic Interview-Revised (ADI-R);\n3. parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility;\n4. stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes;\n5. English-speaking parent and youth able to consistently participate in study procedures;\n6. family resides in United States.",{"count":605,"type":21},44,[141],"The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour\u002Fweek) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.",[28,609,29],"Restricted Behavior",[611,612],"Intervention","Pivotal Response Treatment",{"date":614,"type":52},"2026-06-25",{"date":616,"type":52},"2024-07-11",{"date":618,"type":21},"2028-07-01",{"name":567,"class":59},{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":16,"minAge":547,"maxAge":628,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":631,"briefSummary":632,"conditions":633,"keywords":634,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":98},"100431550","trial-of-center-based-vs-in-home-pivotal-response-treatment-prt-in-autism-100431550","NCT04899544","Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism","Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism","PRT-HvC","Inclusion Criteria:\n\n* Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion;\n* Boys and girls between 2.0 and 5.11 years;\n* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;\n* Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds;\n* Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements;\n* No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);\n* No more than 60 minutes of individual 1:1 speech therapy per week;\n* Availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures.\n\nExclusion Criteria:\n\n* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);\n* Receiving ABA of 15 hours or more;\n* Presence of active medical problem (e.g., unstable seizure disorder or heart disease);\n* Previous adequate Pivotal Response Treatment (PRT) trial;\n* Participants living more than 30 miles from Stanford University;\n* Child's primary language other than English.","5 Years",{"count":630,"type":21},120,[141],"The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).",[29,28,30],[635,636,637,638],"pivotal response treatment","PRT","center based","social and communication",{"date":640,"type":52},"2026-06-24",{"date":642,"type":52},"2022-10-18",{"date":644,"type":21},"2028-09-15",{"name":567,"class":59},{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":4,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":16,"minAge":547,"maxAge":172,"enrollmentInfo":653,"targetDuration":4,"studyType":22,"phases":654,"briefSummary":655,"conditions":656,"keywords":657,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":659,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":663,"locationsCount":98},"100352269","phase-2-a-study-of-esomeprazole-in-children-with-autism-100352269","NCT03866668","A Study of Esomeprazole in Children With Autism","An Open-Label Pilot Study of Esomeprazole in Children With Autism","Inclusion Criteria:\n\n* outpatients 2 to 6 years of age;\n* males and females who are physically healthy;\n* diagnosis of autism spectrum disorder based on clinical evaluation and DSM-5 criteria, and confirmed using the Autism Diagnostic Interview-Revised, and the Autism Diagnostic Observation Schedule or Childhood Autism Rating Scale second edition (CARS-2)\n* care provider who could reliably bring subject to clinic visits, could provide trustworthy ratings, and interacted with subject on a regular basis;\n* ability of subject to swallow the compound;\n* stable concomitant medications for at least 2 weeks (4 weeks if patient took fluoxetine);\n* no planned changes in psychosocial interventions during the open-label trial.\n\nExclusion Criteria:\n\n* DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified;\n* prior adequate trial of Esomeprazole;\n* active medical problems such as unstable seizures, or significant physical illness (e.g., serious liver or renal pathology).",{"count":7,"type":21},[25],"Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive\u002Fstereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of age to participate.",[29,28],[658],"Esomeprazole",{"date":614,"type":52},{"date":661,"type":52},"2019-05-29",{"date":492,"type":21},{"name":567,"class":59},{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":669,"acronym":4,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":16,"minAge":452,"maxAge":172,"enrollmentInfo":671,"targetDuration":4,"studyType":22,"phases":673,"briefSummary":674,"conditions":675,"keywords":676,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":684,"lastUpdatePostDateStruct":685,"startDateStruct":687,"completionDateStruct":688,"leadSponsor":690,"locationsCount":98},"100642616","cognitive-training-in-virtual-reality-for-autism-100642616","NCT07643649","Cognitive Training in Virtual Reality for Autism","Mind in Motion: Assessing the Efficacy of Virtual Reality Cognitive Training in Neurodivergent Children With Autism","Inclusion Criteria:\n\n* Diagnosis of Autism\n* QI \\> 70\n\nExclusion Criteria:\n\n* Severe neurological or sensory comorbidities",{"count":672,"type":21},30,[141],"The Virtual Reality Rehabilitation System (VRRS) is an innovative tool for motor and cognitive rehabilitation that has shown promising results in developmental populations, with evidence of feasibility, safety, acceptability, and positive effects on attention, executive functions, and learning-related processes. Its playful and motivating features, together with the possibility of tailoring task difficulty and delivering intensive training in a controlled environment, make VRRS a promising intervention for children with autism spectrum disorder (ASD), who frequently present weaknesses in visual attention, executive functioning, and visuospatial memory.\n\nThis randomized controlled trial aims to evaluate the efficacy of a VRRS-based cognitive training program in improving visual attention, executive functions, and visuospatial memory in children with ASD, compared with an active control intervention based on conventional cognitive training. Children aged 4 to 6 years 11 months with ASD, non-verbal IQ \\>70, and no severe neurological or sensory comorbidities will be enrolled and randomly assigned to the experimental or control group. The intervention will consist of two 45-minute sessions per week for 12 weeks. VRRS training will include individualized tasks targeting the selected cognitive domains, with adjustable difficulty, execution time, and repetitions. Assessments will be conducted at baseline (T0) and post-intervention (T1). At baseline, non-verbal cognitive functioning will be assessed using Leiter International Performance Scale, Third Edition (LEITER-3), while attention, executive functions, and visuospatial memory will be measured using Preschool Executive Functions Assessment Battery (FE-PS), LEITER-3 attention and memory tasks, Developmental Neuropsychological Assessment - Second Edition (NEPSY-II) (Memory for Designs), and Behavior rating inventory of executive function-preschool version (BRIEF-P). The same battery will be repeated after training to compare pre- and post-intervention scores and estimate the relative efficacy of the two approaches.\n\nIt is hypothesized that children receiving VRRS-based training will show greater improvements in the targeted cognitive functions than those receiving conventional training, supporting the clinical utility of virtual reality as an effective and engaging rehabilitation approach for children with ASD.",[29,28],[148,677,678,679,680,681,682,28,683],"children","Virtual Reality Rehabilitation System","Cognitive Training","Executive Functions","Visual Attention","Visuo-Spatial Memory","Autism Spectrum Condition","2026-06-09",{"date":686,"type":52},"2026-06-11",{"date":357,"type":21},{"date":689,"type":21},"2027-03-31",{"name":691,"class":59},"Istituto per la Ricerca e l'Innovazione Biomedica",{"id":693,"slug":694,"hasResults":12,"nctId":695,"briefTitle":696,"officialTitle":697,"acronym":4,"eligibilityCriteria":698,"healthyVolunteers":12,"sex":16,"minAge":699,"maxAge":368,"enrollmentInfo":700,"targetDuration":4,"studyType":22,"phases":702,"briefSummary":703,"conditions":704,"keywords":705,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":708,"lastUpdatePostDateStruct":709,"startDateStruct":711,"completionDateStruct":713,"leadSponsor":715,"locationsCount":98},"100471516","early-diagnostic-response-model-edrm-100471516","NCT05419895","Early Diagnostic Response Model (EDRM)","Early Diagnostic Response Model (EDRM): Evaluating an Early Screening to Evaluation Pilot Protocol for Children Identified as High Risk for Autism in Early Intervention Health Districts","Inclusion Criteria:\n\n* All families of children between the ages of 16-30 months of age who scored ≥8 on the MCHAT-R and whose BCW provider refers the child to our clinic by 33 months of age will be a possible participant. Evaluations will be done by 36 months of age.\n* Referring BCW provider must be one of the participating BCW health districts in this pilot study.\n* Parent\u002FGuardian needs to have basic English proficiency\n* Parent\u002FGuardian needs to have internet access\n* Child must have exposure to English either at home or in out-of-home care (e.g., childcare setting).\n* Documentation of M-CHAT-R High-Risk failed score (≥ 8) must be documented in referral.\n\nExclusion Criteria:\n\n* Families making self-referrals to the EAC or referrals outside of the targeted BCW districts will be excluded from recruitment for this study.\n* Children above the age of 33 months at the time of the referral will be excluded as the current EDRM protocol has not been developed in this phase of piloting for individuals over this age.\n* Non-English speakers will be excluded from participation due to the current protocol not being applicable to their needs as well as a high correlation between verbal language abilities and social communication and social interaction (SCI) abilities as part of the DSM-5-TR autism criteria.","16 Months",{"count":701,"type":21},300,[141],"Babies Can't Wait (BCW) in Georgia will be referring families with children seeking an autism spectrum disorder (autism) diagnosis at the Emory Autism Center's (EAC) Child Screening and Assessment Clinic.The objective of this study is to develop, pilot, and evaluate a diagnostic protocol for children identified at high risk for autism in the BCW early intervention program screening (part of a public health service). This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.",[28,29],[29,349,706,707],"Telehealth","Assessment","2026-06-08",{"date":710,"type":52},"2026-06-10",{"date":712,"type":52},"2022-06-16",{"date":714,"type":21},"2028-07",{"name":716,"class":59},"Emory University",{"id":718,"slug":719,"hasResults":12,"nctId":720,"briefTitle":721,"officialTitle":722,"acronym":4,"eligibilityCriteria":723,"healthyVolunteers":12,"sex":16,"minAge":724,"maxAge":725,"enrollmentInfo":726,"targetDuration":4,"studyType":22,"phases":728,"briefSummary":729,"conditions":730,"keywords":731,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":736,"lastUpdatePostDateStruct":737,"startDateStruct":739,"completionDateStruct":741,"leadSponsor":743,"locationsCount":745},"100572462","meeting-the-needs-of-young-hispanic-autistic-children-100572462","NCT06733584","Meeting the Needs of Young Hispanic Autistic Children","Meeting the Needs of Young Hispanic Autistic Children: Developing a Culturally and Linguistically Sensitive Intervention to Alleviate Core Social Challenges","Inclusion Criteria:\n\n* Children must be from a Hispanic family experiencing low income, defined as having an income-to-needs ratio of \\\u003C 320% of the federal poverty level, determined by their household size\n* Children must be between 18-42 months old at the start of the study\n* Children must have no other known neurological or genetic concerns or disorders determined by parent report\n* Children must receive a Calibrated Severity Score (CSS) of 4 or higher on the Autism Diagnostic Observational Schedule-2 (ADOS-2) administered by a qualified bilingual assessment associate\n* Families must have a primary home language of English and\u002For Spanish\n\nExclusion Criteria:\n\n* Children who are from a family that is not Hispanic and\u002For does not have an income-to-needs ratio of \\\u003C 320% of the federal poverty level, determined by their household size\n* Children younger than 18 months or older than 42 months at the start of the study\n* Children whose parents report they have any other known neurological or genetic concerns or disorders\n* Children who receive a Calibrated Severity Score (CSS) lower than 4 on the ADOS-2\n* Families who do not have English or Spanish as a primary home language","18 Months","42 Months",{"count":727,"type":21},200,[141],"Purpose of the Study: The goal of this clinical trial is to find out if a technique called the \"mutual gaze procedure\" used in a Culturally and Linguistically Responsive adaptation of Pathways Early Intervention (CLR-Pathways) is the key to improving social communication, language, and everyday skills in young (18-42 months) Hispanic autistic children experiencing low income.\n\nWhat Will Happen: Researchers will compare two versions of CLR-Pathways.\n\n* Version 1: Includes mutual gaze strategies.\n* Version 2: Does not include mutual gaze strategies.\n\nWhat to Expect: Participants will:\n\n* Attend 16 sessions (or 18 weeks if there are cancellations) of Pathways Intervention, each lasting 1.5 hours.\n* Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.",[29],[732,733,734,239,735],"Autism Intervention","Cultural and Linguistic Responsivity","Social development","Hispanic","2026-06-04",{"date":738,"type":52},"2026-06-05",{"date":740,"type":52},"2025-09-22",{"date":742,"type":21},"2028-01",{"name":744,"class":59},"The University of Texas at Dallas",3,{"id":747,"slug":748,"hasResults":12,"nctId":749,"briefTitle":750,"officialTitle":751,"acronym":752,"eligibilityCriteria":753,"healthyVolunteers":12,"sex":16,"minAge":392,"maxAge":18,"enrollmentInfo":754,"targetDuration":4,"studyType":22,"phases":755,"briefSummary":756,"conditions":757,"keywords":760,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":764,"lastUpdatePostDateStruct":765,"startDateStruct":766,"completionDateStruct":768,"leadSponsor":769,"locationsCount":98},"100638999","regulating-together-for-intellectual-disability-and-autism-a-group-behavioral-therapy-for-for-emotion-dysregulation-100638999","NCT07624448","Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation","Adapting a Group Intervention for Emotion Dysregulation in Autism and Intellectual Disability","RT-ID","Child Participant Inclusion Criteria:\n\n* Males, females, or non-binary youth between 8 and 12 years of age\n* Confirmed diagnosis of Autism Spectrum Disorder (ASD)\n* Confirmed diagnosis of Intellectual Disability\n* Fluent in spoken English.\n* Use of flexible phrase speech or greater\n* Meeting clinically significant emotion dysregulation criteria\n* Willing to participate in twice weekly 90-minute sessions\n* Family is willing to keep prescribed psychiatric medication and outside behavioral interventions stable\n* Parent, guardian, or legally authorized representative (LAR) must provide written permission on behalf of the participant\n\nChild Participant Exclusion Criteria:\n\n* Initiation of new psychosocial intervention within 30 days prior to first day of treatment\n* Presence of physical aggression in the child directed towards a peer outside the home (i.e., non-siblings) that resulted in injury within 30 days prior to screening. Other significant disruptive, aggressive, self-injurious, or sexually inappropriate behavior felt to be dangerous or overly disruptive to the group sessions will be reviewed by the study team on an individual basis.\n* Presence of comorbid major neuropsychiatric illness warranting other treatment approaches\n* Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss\n\nCaregiver Inclusion Criteria:\n\n* Age ≥ 18 years\n* Lives and cares for their child with ASD+ID for \\> 50% of the year\n* Fluent in spoken English.\n* Willing to participate in twice weekly 90-minute sessions, including one virtual session weekly\n\nCaregiver Exclusion Criteria:\n\n-Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss",{"count":175,"type":21},[141],"The goal of this study is to help children with autism and a co-occurring intellectual disability and their families learn practical strategies for managing issues like irritability, aggression, and other challenging behaviors. The main objective of this study is:\n\nTo adapt current Regulating Together materials to create an outpatient group program for emotion dysregulation in autism and co-occurring intellectual disability (ASD + ID) that will improve psychosocial outcomes for youth with ASD + ID.",[29,758,759],"Intellectual Disabilities With Other Behavioral Symptoms","Intellectual Disability",[29,761,762,763],"intellectual disability","emotion dysregulation","aggression","2026-06-03",{"date":738,"type":52},{"date":767,"type":21},"2026-10",{"date":162,"type":21},{"name":770,"class":59},"Children's Mercy Hospital Kansas City"]