[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autism-spectrum-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autism-spectrum-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,317,0,25,[9,61,99,125,159,187,215,240,271,298,324,357,385,412,439,469,488,517,534,553,569,605,633,660,683],{"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":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":16,"minAge":70,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100492933","compassion-for-psychiatric-disorders-and-self-stigma-100492933","NCT05698589","COMpassion for Psychiatric Disorders And Self-Stigma","Compassion Focused Therapy (CFT) for the Reduction of the Internalized Stigma of Mental Disorders: a Multi-center, Prospective, Randomized, Controlled Study","COMPASS","Inclusion Criteria:\n\n1. Patient ≥18 years of age\n2. Patient informed of the results of the preliminary medical examination\n3. Patient affiliated to a social health insurance plan (beneficiary or beneficiary's family)\n4. Patient with one or several diagnoses of chronic psychiatric disorder (schizophrenia, schizoaffective disorder, bipolar disorder, recurrent major depression, borderline personality disorder) or a neurodevelopmental disorder (autism spectrum disorder) treated as an outpatient or in a day hospital\n5. CGI-Severity score\\\u003C6 assessed by the psychiatrist (Berk et al., 2008) ISMI score indicating moderate to high self-stigma (\\>2.5; Lysaker et al., 2007)\n\n   Exclusion criteria:\n6. Patient in an exclusion period determined by a previous or ongoing study\n7. Patient participating in an interventional study involving psychotherapy or an experimental drug\n8. Patient in acute episode of their disorder according to the CGI Severity score\n9. Patient in a medical emergency or immediate life-threatening situation\n10. Patients with an intellectual disability (IQ\\\u003C70) estimated via the fNART (Mackinnon \\& Mulligan, 2005)\n\n12\\. Legal issues: care under constraint or patient deprived of freedom because of a judicial measure 13. Patient who does not speak and read French sufficiently",{"count":108,"type":21},336,[110],"NA","People with mental disorders face frequent stigmatizing attitudes and behaviors from others . In response to this, they tend to isolate themselves, with the risk of impeding care and the process of recovery and integration into society . Stigmatization can also be assimilated by patients themselves - i.e. self-stigma. Self-stigma is involved in diminished coping skills that lead to social avoidance and difficulties in adhering to care . Reducing self-stigma and its emotional corollary, shame, is thus crucial to attenuate the disability associated with mental illness. Shame is inherent to self-stigma and leads to difficulties in adhering to care as well as greater severity of clinical presentations . Compassion Focused Therapy (CFT) is a third wave cognitive behavioral therapy that targets shame reduction and hostile self-to-self relationship and allows for symptom improvement while increasing self-compassion, a major resilience factor . Although shame is a prominent part of the concept of self-stigma, the efficacy of CFT has never been evaluated in individuals with high levels of self-stigma.\n\nIn this study, the investigators will evaluate the efficacy and acceptability of a group based CFT program on decreasing self-stigma, compared to treatment as usual (TAU) and a psychoeducation program whose efficacy has been assessed in a previous trial.",[113,114,115,116,28],"Bipolar Disorder","Schizophrenia","Depression","Borderline Personality Disorder",{"date":91,"type":52},{"date":119,"type":52},"2023-04-03",{"date":121,"type":21},"2028-03-01",{"name":123,"class":59},"University Hospital, Strasbourg, France",7,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":16,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":136,"phases":4,"briefSummary":137,"conditions":138,"keywords":143,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":98},"100410940","developing-brain-impulsivity-and-compulsivity-100410940","NCT04631042","Developing Brain, Impulsivity and Compulsivity","An Observational Study of the Developing Brain, Impulsivity and Compulsivity","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Must be between 6 and 80 years of age.\n3. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Cognitively not capable of performing study procedures or lack of capacity to provide informed consent. Indications of a lack of cognitive capacity could include a known full-scale IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)\n2. Very premature birth (i.e., birth before 32 weeks of gestational age).\n3. Any known brain abnormalities (e.g., tumor, periventricular leukomalacia, microcephaly) or history of medical conditions known to affect cerebral anatomy (e.g., epilepsy, history of stroke, head injury with a loss of consciousness of one hour or more).\n4. Psychotic disorders (including schizophrenia, psychosis not otherwise specified).\n5. Dementia, or other conditions that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study.\n6. Pregnant women.\n7. Any other medical or psychiatric condition that in the opinion of the PI may confound study data\u002Fassessments.\n\nAdditional exclusion criteria for optional MRI procedure:\n\n1\\. Individuals who are not able to receive an MRI (e.g., metal bioimplants, claustrophobia, inability to lie flat on their backs, pregnant women, and any other contraindications for MRI scanning according to the NMR Center MRI safety guidelines).","6 Years","80 Years",{"count":135,"type":21},1100,"OBSERVATIONAL","Background:\n\nImpulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role.\n\nObjective:\n\nTo learn about genetic \\& brain features that explain why levels of impulsivity and compulsivity vary across people.\n\nEligibility:\n\nPeople ages 6 - 80\n\nDesign:\n\nParticipants will be screened with a medical history and medical record review.\n\nParticipants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys.\n\nParticipants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies and they may give blood to make induced pluripotent stem cells. Participants may have their face and irises photographs taken.\n\nParticipants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game.\n\nParticipants may ask family members to join the study. Researchers are particularly interested in recruiting twin pairs to the study.\n\nParticipants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month.",[139,140,141,142,28],"Typical Development","Obsessive Compulsive Disorder","Conduct Disorder","Attention Deficit Hyperactivity Disorder",[144,145,146,147,148,149,150],"Neurodevelopmental disorder","Twin","Natural History","Heritability","Glutamate","developmental trajectory","Brain Connectivity",{"date":91,"type":52},{"date":153,"type":52},"2022-09-30",{"date":155,"type":21},"2031-12-31",{"name":157,"class":158},"National Institute of Mental Health (NIMH)","NIH",{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":16,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":183,"leadSponsor":185,"locationsCount":98},"100652591","social-robots-and-board-games-for-children-with-autism-spectrum-disorder-100652591","NCT07775937","Social Robots and Board Games for Children With Autism Spectrum Disorder","Effectiveness of Social Robot-Assisted Intervention Combined With Board Games on Socio-Emotional Skills in Children With Autism Spectrum Disorder: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n1. Children aged 4 to 10 years, of any biological sex.\n2. Confirmed clinical diagnosis of Autism Spectrum Disorder (ASD).\n3. Cognitive ability: Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT) results indicating borderline to normal cognitive function, with a Developmental Quotient (DQ) \\>= 70.\n4. Socio-emotional ability: CDIIT socio-emotional subscale indicating borderline development, with a Developmental Quotient (DQ) between 70 and 84.\n5. Legal guardian provides written informed consent and child provides assent where appropriate.\n\nExclusion Criteria:\n\n1. Inability to comprehend or engage in interactive activities involving the Kebbi Air robot or physical board games.\n2. Presence of other primary diagnoses affecting emotional or social functioning, such as severe neurodevelopmental disorders, psychiatric disorders, or ASD with severe emotional disturbances that prevent participation in intervention activities (CDIIT DQ \\\u003C 70).\n3. Inability to commit to regular weekly intervention sessions, or parental unwillingness to participate in required observational assessments and questionnaire completion.\n4. Strong behavioral resistance or severe aversion to digital interactive tools or board game activities.\n5. Inability to follow simple two-step verbal instructions after a preliminary 10-minute trial assessment conducted by the occupational therapist.","4 Years","10 Years",{"count":169,"type":21},20,[110],"This pilot randomized controlled trial evaluates the effectiveness of combining social robot-assisted intervention with physical board games to improve socio-emotional skills in children with Autism Spectrum Disorder (ASD).\n\nChildren with ASD often face challenges in emotion recognition, emotional regulation, and social interaction. This study aims to investigate whether integrating an interactive social robot (Kebbi) into board game activities can enhance children's social engagement, emotional comprehension, and cooperative behaviors compared to conventional occupational therapy. Participants will be randomly assigned to either the robot-assisted board game group or the conventional occupational therapy group.",[28,173],"Child Development Disorders, Pervasive",[175,176,177,178,179],"Social Robots","Board Games","Occupational Therapy","Socio-Emotional Skills","Emotion Recognition","2026-08-17",{"date":49,"type":52},{"date":89,"type":52},{"date":184,"type":21},"2026-12-31",{"name":186,"class":59},"National Taiwan University Hospital",{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":16,"minAge":70,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":98},"100652217","medial-prefrontal-cortex-brain-magnetic-stimulation-in-autism-100652217","NCT07770451","Medial Prefrontal Cortex Brain Magnetic Stimulation in Autism","The Efficacy and Brain Mechanism of Deep Transcranial Magnetic Stimulation in Autism: A Pilot Study Targeting Medial Prefrontal Cortex","Inclusion Criteria:\n\n* Having a diagnosis of autism spectrum disorder based on DSM-5-TR diagnosis criteria\n* Aged 18-45 years old\n* No change of medications in the past three months\n\nExclusion Criteria:\n\n* Comorbidity of schizophrenia, substance use disorder,\n* Had major medical diseases (e.g., malignancy, severe cardiac, hepatic, renal diseases, or active CNS or systemic infection) or major neurological disease (e.g., uncontrolled epilepsy, brain tumors or hemangioma, severe head trauma)\n* Contraindications of MRI or TMS procedure: Ferromagnetic material in the skull, head, and neck; claustrophobia; had received neurosurgery, etc.\n* Receiving electroconvulsive therapy or TMS in the past three months","45 Years",{"count":169,"type":21},[110],"Despite decades of research, no definitive, effective biological treatments exist for core symptoms of Autism Spectrum Disorder (ASD). Emerging evidence suggests that conventional Transcranial Magnetic Stimulation (TMS) targeting the dorsolateral prefrontal cortex or posterior superior temporal sulcus may reduce repetitive behaviors, but its efficacy on social communication remains inconsistent.\n\nDeep Transcranial Magnetic Stimulation (dTMS) allows for the stimulation of deeper brain structures. Deep social brain networks, such as the medial prefrontal cortex (mPFC), play a critical role in social cognition and mentalizing processes. Targeting the mPFC with dTMS holds potential for improving core impairments in social cognition among individuals with ASD. This pilot study aims to evaluate the efficacy of dTMS on social cognition, mPFC-related functional connectivity, and clinical symptoms (autism severity, stereotyped behaviors, sensory symptoms, and emotion regulation).",[28],[200,201,202,203,204,205,206,207],"autism spectrum disorder","asd","Deep Transcranial Magnetic Stimulation","dTMS","Medial Prefrontal Cortex","mPFC","brain stimulation","neuromodulation","NOT_YET_RECRUITING",{"date":89,"type":52},{"date":211,"type":21},"2026-12-01",{"date":213,"type":21},"2028-12-31",{"name":186,"class":59},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":16,"minAge":18,"maxAge":70,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":98},"100652277","phase-4-semaglutide-in-youth-with-autism-spectrum-disorder-100652277","NCT07770152","Semaglutide in Youth With Autism Spectrum Disorder","Semaglutide for Metabolic and Adiposity-Related Targets in Youth With Autism Spectrum Disorder (SMART-ASD)","GLP1","Inclusion Criteria (Semaglutide Group):\n\n* 12-18 years of age\n* Epic-confirmed diagnosis of ASD\n* Obesity defined as BMI ≥95th percentile for age and sex\n* Have Medicaid or other insurance that will cover semaglutide or the parent is willing to pay for semaglutide out of pocket\n* Have a parent who is willing to provide informed consent\n* Can attend in-person, e-visits, or telehealth visits for 12 months\n* English speaking\n\nExclusion Criteria (Semaglutide Group):\n\n* Healthworks patient who has lost \\>5% body weight over the past 3 months\n* Are on a weight loss-promoting medication such as Metformin or Topamax with a dose change in the past 3 months\n* Have Type 1 or Type 2 diabetes\n* Have a personal or first-degree family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia 2\n* Have been on GLP-1 RAs in the past 12 months\n* Have significant GI conditions (e.g., pancreatitis),\n* Are pregnant or breastfeeding\n* Have catatonia or a condition that may affect compliance and safety\n\nInclusion Criteria (Historical Control Group):\n\n* Healthworks patients treated between January 1, 2021-December 31, 2025\n* 12-18 years of age\n* Confirmed diagnosis of ASD\n* Have obesity defined as BMI ≥95th percentile for age and sex\n* Have BMI and SMM outcomes assessed at M0, M6, or M12\n* Age groups 12-14 years old and 15-18 years old and sex matched to youth in the semaglutide group",{"count":224,"type":21},42,[226],"PHASE4","This study is a 6-month, two-arm, RCT which will evaluate the effectiveness and safety of semaglutide in adolescents aged 12-18 years with autism spectrum disorder (ASD) and obesity. The primary outcome is change in body mass index (BMI, kg\u002Fm²) from baseline to Month 6. Secondary, descriptive outcomes are changes in metabolic parameters (e.g., lipid levels), side effects, and compliance with semaglutide.",[28,229],"Obesity",[28,229,231],"Semaglutide","2026-08-14",{"date":89,"type":52},{"date":235,"type":21},"2026-09-01",{"date":237,"type":21},"2029-09-01",{"name":239,"class":59},"Children's Hospital Medical Center, Cincinnati",{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":16,"minAge":167,"maxAge":70,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":270},"100652192","safety-and-efficacy-of-ndtx-03-in-children-and-adolescents-with-asd-or-scd-100652192","NCT07770867","Safety and Efficacy of NDTx-03 in Children and Adolescents With ASD or SCD","A Multicenter, Prospective, Randomized, Evaluator-Blinded, Superiority, Confirmatory Trial to Evaluate Safety and Efficacy of NDTx-03 for Improving Social Situation Recognition and Interaction in Children and Adolescents With ASD or SCD","Inclusion Criteria:\n\n1. Children and adolescents aged 10 to 18 years.\n2. Diagnosed with Autism Spectrum Disorder (ASD) or Social Communication Disorder (SCD) by the clinical judgment of a psychiatrist according to DSM-5 diagnostic criteria, based on the Autism Diagnostic Interview-Revised (ADI-R), Korean Wechsler Intelligence Scale for Children, Fifth Edition (K-WISC-V), and clinical assessment. Previously performed ADI-R and Wechsler intelligence scale results may be used; for Wechsler intelligence scales, any test type or version may be used, including K-WISC-V, WPPSI, or WAIS.\n3. Full-Scale Intelligence Quotient (FSIQ) \\>= 70 or General Ability Index (GAI) \\>= 70 based on a Korean Wechsler intelligence scale (regardless of type or version, including K-WISC-V, WPPSI, or WAIS). Previously performed results may be used.\n4. Able to use NDTx-03 installed on a smartphone, either independently or with assistance from a parent\u002Flegal guardian.\n5. Able to comply with the recommended investigational device application schedule (5 times per week, 8 weeks, 40 sessions).\n6. Agree not to use any medical device other than the investigational device during the clinical trial.\n7. Agree that there will be no changes during the study in the regimen of medications that may significantly affect sociality. Medications being taken at screening may be continued, but total daily dose, active ingredient, and other regimen details must remain unchanged until the end-of-study visit.\n8. Agree not to participate in additional Applied Behavior Analysis (ABA) treatment\u002Frehabilitation\u002Feducation or sociality-related treatment\u002Frehabilitation\u002Feducation programs during the study. Programs being received at screening may be continued, but frequency and treatment method must remain unchanged until the end-of-study visit.\n9. The participant and parent (or legal guardian) voluntarily decide to participate and provide written informed consent\u002Fassent using the participant information sheet and informed consent form.\n10. Willing to comply with the clinical trial protocol.\n\nExclusion Criteria:\n\n1. Clinically significant behavioral problems, emotional regulation problems, psychotic symptoms, or risk of self-harm or harm to others at a level that may affect the treatment process.\n2. Severe acute or chronic medical or psychiatric disease.\n3. Serious trauma or surgery within 4 weeks before the screening date.\n4. Other severe neurological disease or disability, such as brain lesion disorder or mental disorder\u002Fdisability.\n5. Currently participating in another clinical trial or participated in another clinical trial within 30 days before the screening date.\n6. Less than 24 months have elapsed since the end date of application of the investigational medical device NDTx-01 (or Buddy In) as of the screening date.\n7. Participation in a clinical trial of, or prior experience using, a digital therapeutic device or software-based intervention program that may affect efficacy assessments of this study, including cognitive function, attention, executive function, language, social development, social skills, behavior, or emotional regulation, within 12 months before the baseline visit.\n8. Within 8 weeks before baseline, a change in the dosage or regimen of medications that may significantly affect sociality, or a change in participation in treatment\u002Frehabilitation\u002Feducation programs that may significantly affect sociality.\n9. Any other case in which the investigator determines that participation is inappropriate for ethical reasons or because it may affect clinical trial results.",{"count":248,"type":21},156,[110],"The purpose of this study is to evaluate the safety of NDTx-03 used together with treatment as usual (TAU) and to determine whether NDTx-03 plus TAU is more effective than TAU alone in improving social situation recognition and interaction in children and adolescents with autism spectrum disorder (ASD) or social communication disorder (SCD).",[28,252],"Social Communication Disorder",[28,252,30,254,255,256,257,258,259,260],"SCD","Digital therapeutics","Cognitive therapeutic software","NDTx-03","Asperger","DTX","SaMD","2026-08-13",{"date":89,"type":52},{"date":264,"type":21},"2026-08",{"date":266,"type":21},"2027-09",{"name":268,"class":269},"Neudive Inc.","INDUSTRY",6,{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":16,"minAge":132,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":98},"100641619","using-apollo-neuro-in-autistic-children-with-self-injurious-behavior-100641619","NCT07648420","Using Apollo Neuro in Autistic Children With Self-Injurious Behavior","Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, in Autistic Children With Self-Injurious Behavior","Inclusion Criteria for child:\n\n* Diagnosis of autism spectrum disorder (ASD), as reported by caregiver\n* Presence of self-injurious behavior, as reported by caregiver\n* Demonstrates sensory over and\u002For under- responsivity\n* Aged 6 years to 14 years, 11 months (179 months) at the time of enrollment\n* Has a caregiver willing and able to provide consent and participate in study procedures\n\nExclusion Criteria for child:\n\n* Has medical condition that may increase risk with use of a wearable nibrotactile device, including:\n\n  * implanted medical or neurological devices (e.g., pacemaker)\n  * significant cardiac conditions or arrhythmias\n  * history of syncope (fainting)\n* Known seizure disorder without physician clearance\n* Regular use of nibrotactile or autonomic- modulating wearable devices within the past 90 days\n* Any condition that, in the judgment of the investigator, would interfere with safe participation or interpretation of study procedures\n\nInclusion Criteria for Caregiver:\n\n* Parent or legal guardian of the enrolled child participant\n* Able to provide informed consent in English\n* Able and willing to support device use according to study protocol and complete study-related data collection\n* Has access to a smartphone or compatible device capable of operating the Apollo Neuro application for the duration of study period\n\nExclusion Criteria for Caregiver:\n\n• Unable to provide informed consent in English","179 Months",{"count":280,"type":21},18,[110],"This study will evaluate the feasibility and acceptability of the Apollo Neuro, a wearable vibrotactile sensory device, in autistic children who engage in self-injurious behavior (SIB).\n\nParticipants will wear the device for at least 3 hours per day over a 30-35 day period with caregiver support. Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver-reported self- injurious and repetitive behaviors during the study period. This preliminary, single-group study is not designed to evaluate efficacy and will inform the design of future controlled trials.",[284,28],"Self-Injurious Behavior",[286,287,288,289,290],"Apollo Neuro Device","Sensory Responsivity","Autonomic Regulation","Wearable Device","Vibrotactile Stimulation",{"date":180,"type":52},{"date":293,"type":21},"2026-12",{"date":295,"type":21},"2027-11",{"name":297,"class":59},"Virginia Commonwealth University",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":16,"minAge":305,"maxAge":306,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":311,"conditions":312,"keywords":313,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":323},"100533699","phase-3-safety-and-tolerability-trial-of-lumateperone-in-pediatric-patients-with-schizophrenia-bipolar-disorder-or-autism-spectrum-disorder-100533699","NCT06229210","Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder","An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder","Inclusion Criteria:\n\n* Able to provide consent as follows:\n\n  * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent;\n  * The patient must provide written assent to study enrollment;\n* Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder;\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).\n* Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.\n\nRollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.\n\nExclusion Criteria:\n\n* Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include:\n\n  * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.\n  * For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary.\n* In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or\n\n  * At Screening, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;\n  * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or\n  * At Screening or Baseline, scores \\> 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or\n  * The patient is considered to be an imminent danger to him\u002Fherself or others.","5 Years","17 Years",{"count":308,"type":21},300,[310],"PHASE3","This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.",[114,113,28],[314],"Pediatric","2026-08-11",{"date":261,"type":52},{"date":318,"type":52},"2024-01-25",{"date":320,"type":21},"2032-04-28",{"name":322,"class":269},"Intra-Cellular Therapies, Inc.",61,{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":16,"minAge":70,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"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":333,"type":21},40,[110],"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],[29,338,339,340,341,342,343,344,345,346,347],"Autistic adults","Neurodiversity","Neurodivergent","Dance","Yoga","Mindful","Social communication","Well-being","Lifestyle intervention","Adaptive movement","2026-08-10",{"date":350,"type":52},"2026-08-12",{"date":352,"type":21},"2027-01-17",{"date":354,"type":21},"2027-04-04",{"name":356,"class":59},"USC Glorya Kaufman School of Dance",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":16,"minAge":132,"maxAge":18,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":383,"locationsCount":98},"100650836","lego-based-play-therapy-for-children-with-autism-spectrum-disorder-100650836","NCT07751679","LEGO-Based Play Therapy for Children With Autism Spectrum Disorder","The Effects of LEGO®-Based Play Therapy on Social Skills and Play Skills in Children With Autism Spectrum Disorder","LEGO-ASD","Inclusion Criteria:\n\n* Children aged 6 to 12 years.\n* Diagnosis of Autism Spectrum Disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) or the International Classification of Diseases, 11th Revision (ICD-11).\n* Regular attendance at the Istanbul Gedik University Center for Barrier-Free Life Practice and Research.\n* No physical health condition that would prevent participation in group activities.\n* Written informed consent obtained from a parent or legal guardian.\n* Willingness of the child to participate in the study.\n\nExclusion Criteria:\n\n* Presence of a physical, neurological, or psychiatric condition that would prevent participation in LEGO®-Based Group Play Therapy.\n* Absence from more than 20% of the planned 12 intervention sessions. Incomplete completion of the data collection instruments by the parent or legal guardian, or failure to participate in the post-intervention or follow-up assessments.\n* Withdrawal from the study by the child or the parent\u002Flegal guardian at any stage of the research",{"count":366,"type":21},60,[110],"Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by difficulties in social communication and interaction, as well as restricted and repetitive patterns of behavior. Children with ASD often experience challenges in developing social relationships and engaging in age-appropriate play activities.\n\nThis study aims to evaluate the effectiveness of LEGO®-Based Play Therapy in improving social skills and play skills in children with autism spectrum disorder. Participants are assigned to either a LEGO®-Based Play Therapy group or a control group. The intervention consists of structured group sessions conducted over a 12-week period using collaborative LEGO® building activities designed to promote communication, cooperation, problem-solving, and peer interaction.\n\nThe primary outcomes are changes in social skills and play skills measured using validated assessment tools before and after the intervention. The findings of this study may provide evidence regarding the effectiveness of LEGO®-Based Play Therapy as a supportive intervention for children with autism spectrum disorder and contribute to the development of evidence-based psychosocial interventions.",[28],[28,371,372,373,374,375,376],"LEGO®-Based Play Therapy","Social Skills","Play Skills","Children","Psychosocial Intervention","Randomized Controlled Trial","2026-08-06",{"date":379,"type":52},"2026-08-07",{"date":264,"type":21},{"date":382,"type":21},"2027-01",{"name":384,"class":59},"Marmara University",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":398,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":98},"100515151","improving-social-communication-in-individuals-with-asd-using-ai-100515151","NCT05987774","Improving Social Communication in Individuals With ASD Using AI","Using Artificial Intelligence (AI) to Improve Social Communication in Autistic Individuals","Inclusion Criteria:\n\n* Primary diagnosis of autism spectrum disorder (ASD)\n* Age of adolescents and adults: between 11-35 years\n* Age of minimally verbal children: between 3-5 years\n* Ability to engage in social conversation using full sentences for a 20-minute period (adolescents and adults)\n* Verbal communication difficulties in an individual targeted area (e.g., empathy) as measured on the communication sample\n\nParticipants with a co-occuring diagnosis of ADHD, depression, or social anxiety will not be excluded since these are very common in this population and are often related to or a bi-product of difficulties with social communication.\n\nExclusion Criteria:\n\n* Non-documented or self-diagnosis of ASD\n* At or above 60% correct responding on targeted area of social conversation during conversation probe (adolescents and adults)\n* No significant language delay (young children)\n* No access to phone or computer for intervention sessions\n* Inability to carry on a conversation during the conversation probe\n* Apparent intellectual impairment that interferes with the ability to carry on a conversation (e.g., responds only in single words or does not respond to conversation, lack of understanding of questions or content during conversation probe)\n* Non-English speaking\n* Serious medical or psychiatric issues that may interfere with conversation or the ability to complete the program\n* Lack of interest in participating.","35 Years",{"count":394,"type":21},540,[110],"The purpose of this study is to identify whether researched and commonly used face-to-face interventions can be effectively implemented through artificial intelligence (AI) using an application on the phone or computer. The investigators plan to recruit individuals diagnosed with autism spectrum disorder who demonstrate challenges with social communication. Modules focusing on various difficulties experienced by autistic individuals will provide practice and feedback using voice recognition and feedback. If effective, this intervention can be scaled up to provide cost-effective accessible assistance to individuals, particularly those who do not have access to care or prefer to secure services in the comfort of their own homes.",[28],[399,400,401,402,403,404,200],"AI","autism","LLMs","GPT","social skills","autism support",{"date":348,"type":52},{"date":407,"type":52},"2023-10-15",{"date":409,"type":21},"2050-06-30",{"name":411,"class":59},"Stanford University",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":16,"minAge":419,"maxAge":306,"enrollmentInfo":420,"targetDuration":4,"studyType":22,"phases":422,"briefSummary":423,"conditions":424,"keywords":427,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":435,"leadSponsor":437,"locationsCount":98},"100651053","feasibility-acceptability-and-preliminary-effectiveness-of-cognitive-behavioral-therapy-for-depression-in-autistic-youth-in-clinical-settings-100651053","NCT07755137","Feasibility, Acceptability, and Preliminary Effectiveness of Cognitive Behavioral Therapy for Depression in Autistic Youth in Clinical Settings","CBT-DAY","Inclusion Criteria:\n\nAutistic youth:\n\n* Age 11 to 17 years\n* Prior clinical diagnosis of autism (per record review)\n* At least a fifth grade reading level\n* An ability to engage in sessions verbally (i.e., full length sentences)\n* Elevated symptoms of depression at baseline (RCADS)\n* Depression is a current clinical concern and participant is appropriate for intervention (per investigator determination)\n* At least one parent\u002Fcaregiver willing and able to participate\n* Eligible to receive services at CHLA\n* If taking psychotropic medication, regimen must be stable for at least 8 weeks prior to baseline\n\nParents\u002FCaregivers:\n\n* Age 18 years or older\n* Parent or legal guardian of participating youth\n* Able to provide informed consent\n* Comfortable reading, writing, or speaking English or Spanish\n* Willing to participate in study procedures\n\nExclusion Criteria:\n\nAutistic youth:\n\n* Lifetime diagnosis of bipolar disorder, psychotic disorder, or intellectual disability\n* Severe suicidal or homicidal ideation or self-injury requiring immediate higher-level care\n* Currently receiving psychotherapy for depression\n* Changes in psychotropic medication regimen during study participation (participants may be withdrawn)\n* A reading level below fifth-grade\n* An inability to engage in sessions verbally (i.e., nonverbal, minimally verbal)\n\nParents\u002FCaregivers:\n\n* Not the parent or legal guardian of the participating youth\n* Unable to provide informed consent\n* Not comfortable reading, writing, or speaking English or Spanish\n* Unwilling to participate in study procedures","11 Years",{"count":421,"type":21},140,[110],"The goal of this clinical trial is to learn if Cognitive Behavioral Therapy for Depression in Autistic Youth (CBT-DAY) can improve depressive symptoms and related mechanisms in autistic youth aged 11-17 years with depression receiving care in outpatient clinical settings.\n\nThe main questions it aims to answer are:\n\n* Does CBT-DAY lead to greater reductions in depressive symptom severity compared to treatment-as-usual (TAU)?\n* Does CBT-DAY improve key mechanisms (emotional reactivity, self-esteem, and autism self-knowledge) associated with depression outcomes?\n\nResearchers will compare CBT-DAY versus treatment-as-usual (TAU) to see if CBT-DAY results in greater improvements in depressive symptoms and related outcomes.\n\nParticipants will:\n\n* Complete baseline, mid-treatment, post-treatment, and 3-month follow-up assessments (surveys and interviews)\n* Be randomly assigned to receive either 12 weeks of CBT-DAY or treatment-as-usual\n* Participate in therapy sessions during the 12-week intervention period\n* Complete follow-up assessments three months after treatment to evaluate longer-term outcomes",[28,425,426],"Depressive Disorder","Anxiety Disorders",[428,400,429,430,431],"depression","youth","anxiety","cognitive behavioral therapy","2026-08-05",{"date":348,"type":52},{"date":211,"type":21},{"date":436,"type":21},"2029-12-01",{"name":438,"class":59},"Children's Hospital Los Angeles",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":16,"minAge":446,"maxAge":447,"enrollmentInfo":448,"targetDuration":4,"studyType":22,"phases":450,"briefSummary":451,"conditions":452,"keywords":453,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":465,"leadSponsor":467,"locationsCount":98},"100649899","effects-of-hippotherapy-in-children-with-autism-spectrum-disorder-100649899","NCT07739693","Effects of Hippotherapy in Children With Autism Spectrum Disorder","The Effects of Hippotherapy on Physical Function, Bladder and Bowel Symptoms, and Social Communication in Children With Autism Spectrum Disorder","Inclusion Criteria:\n\n* Diagnosis of autism spectrum disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria\n* Ability to understand and follow basic verbal instructions\n* Ability to stand independently for at least 30 seconds\n* Voluntary participation in the study and written informed consent provided by a parent or legal guardian\n\nExclusion Criteria:\n\n* Presence of an active infection\n* Bladder or bowel symptoms attributable to an organic condition, such as anorectal malformation or Hirschsprung disease\n* Presence of another neurological or orthopedic condition that may affect participation or study outcomes, such as cerebral palsy or hip dislocation\n* Inability to attend the treatment program regularly\n* Receipt of hippotherapy within the previous 12 months\n* History of epilepsy or seizures\n* Surgery involving the spine or abdominopelvic region within the previous 12 months","7 Years","15 Years",{"count":449,"type":21},30,[110],"Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties in social communication and interaction, as well as impairments in physical function domains such as postural control, balance, coordination, and motor planning. This study is designed as a randomized controlled trial to determine the effects of hippotherapy, applied in addition to a special education program, on physical function, bladder-bowel symptoms, and social communication level in children with ASD.",[28],[454,455,456,457,458,344,374,459,460],"Autism spectrum disorder","Hippotherapy","Physical function","Postural balance","Bladder and bowel dysfunction","Hand grip strength","Trunk control","2026-08-02",{"date":463,"type":52},"2026-08-04",{"date":264,"type":21},{"date":466,"type":21},"2027-05",{"name":468,"class":59},"Fenerbahce University",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":16,"minAge":132,"maxAge":18,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":477,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":484,"leadSponsor":486,"locationsCount":4},"100649921","occupational-therapy-intervention-in-children-diagnosed-with-early-and-late-autism-spectrum-disorder-100649921","NCT07740863","Occupational Therapy Intervention in Children Diagnosed With Early and Late Autism Spectrum Disorder","Comparison of the Effects of Occupational Therapy Intervention on Sensory Processing and Executive Functions in Children Diagnosed With Early and Late Autism Spectrum Disorder","Inclusion Criteria:\n\n* being between 6 and 12 years of age\n* having a formal diagnosis of ASD\n* actively attending occupational therapy sessions.\n\nExclusion Criteria:\n\n* Children with severe physical disabilities, significant visual or hearing impairments, or severe cognitive and communication limitations preventing participation in the assessment process were excluded.",{"count":449,"type":21},[110],"Occupational Therapy Intervention in Children Diagnosed with Early and Late Autism Spectrum Disorder",[28],"2026-07-31",{"date":482,"type":52},"2026-08-03",{"date":93,"type":21},{"date":485,"type":21},"2027-03-01",{"name":487,"class":59},"SEDANUR GÜRLEK",{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":16,"minAge":167,"maxAge":306,"enrollmentInfo":496,"targetDuration":4,"studyType":22,"phases":498,"briefSummary":499,"conditions":500,"keywords":504,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":514,"leadSponsor":516,"locationsCount":98},"100650387","smart-inhaler-and-remote-asthma-management-in-adolescents-with-intellectual-and-developmental-disabilities-100650387","NCT07746921","Smart Inhaler and Remote Asthma Management in Adolescents With Intellectual and Developmental Disabilities","A Pilot Randomized Controlled Trial: Utilizing a Digital Inhaler Cap to Support for Remote Asthma Management in Adolescents With Intellectual and Developmental Disabilities","IDD","Inclusion Criteria:\n\n* Adolescents ages 10-17 years\n* Diagnosis of mild-to-moderate intellectual disability (ID) ICD-10: F70-F71 and\u002For diagnosis of developmental disability, including autism: ICD-10: F80-89; (Diagnosis of ID and\u002For autism in the EMR may be used to reach out to potential families).\n* Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma or diagnosis indicated in the EMR: ICD-10: J45.40-J45.909; (Diagnosis of ID and\u002For autism in the EMR may be used to reach out to potential families).\n* Parent\u002Flegal guardian has a smartphone and is willing to download an application associated with the CapMedic device, is assigned to the intervention group.\n* Parent\u002Flegal guardian is willing to answer questions about their child.\n* Parent\u002Flegal guardian and adolescent must have the ability to understand study procedures and to comply with them for the entire length of the study\n* English or Spanish-speaking participants\n* Not currently involved in other studies using digital inhalers\n* Males and females of reproductive capability will be enrolled: contraception is not necessary or required.\n* Participants must use any of the following MDIs (as indicated by the 510(k) as maintenance inhaled corticosteroids (ICS): Advair HFA, Flovent HFA, Symbicort HFA, Alvesco HFA, Dulera HFA, and Asmanex HFA.\n\nExclusion Criteria:\n\n* Health status or any clinical conditions: limited life expectancy and complex respiratory pathologies (e.g., tracheostomy, restrictive lung disease, bronchopulmonary dysplasia, cystic fibrosis) to prevent confounding in asthma treatment outcomes.\n* Inability or unwillingness of individual or legal guardian\u002Frepresentative to give written informed consent.",{"count":497,"type":21},34,[110],"Correct use of daily medications containing inhaled corticosteroids is key for asthma control, yet children with intellectual and developmental disabilities (IDD) face additional barriers to proper inhaler use. Smart inhalers, a novel technology that provides guidance and immediate feedback on inhaler use techniques, have been shown to enhance correct medication administration in the typically developing pediatric population, but their effectiveness has not been evaluated on the pediatric IDD population for remote home use. This study aims to investigate whether daily application of smart inhalers (1) is feasible, acceptable and usable in the IDD population for remote asthma management, (2) improves the rate of medication use and correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population for remote home use.",[501,502,503,28],"Asthma in Children","Intellectual Disabilities (F70-F79)","Developmental Disability",[505,506,507,508,509,510],"smart inhaler","asthma","remote home management","medication adherence","intellectual disability","developmental disability","2026-07-30",{"date":432,"type":52},{"date":348,"type":21},{"date":515,"type":21},"2027-08-09",{"name":438,"class":59},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":16,"minAge":70,"maxAge":71,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":525,"briefSummary":526,"conditions":527,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":98},"100507243","the-plasticity-of-social-brain-network-in-adults-with-autism-spectrum-disorder-100507243","NCT05884853","The Plasticity of Social Brain Network in Adults With Autism Spectrum Disorder","Inclusion Criteria:\n\n* age between 18 and 50\n* diagnosed with ASD from licensed mental health or medical professional based on DSM5\n* have social problems\n* motivated to participate in the treatment\n* fluent in chinese\n* caregiver also fluent in chinese and motivated to participate\n* had a full-scale IQ \\> 70 on WAIS-IV\n* scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD.\n\nExclusion Criteria:\n\n* history of major mental illness, such as bipolar affective disorder, schizophrenia, psychosis, or neurological diseases\n* visual impairment and\u002For hearing impairment\n* any metal, electronic part that cannot be removed from the body, or being pregnant, which may not be able to use fMRI scan.",{"count":524,"type":21},120,[110],"\"Social brain\" refers to brain regions dedicated to processing social information and enabling us to recognize and evaluate others' mental states. The social brain hypothesis suggests that our brains evolve to navigate complex social systems. The social brain is hypothesized to consist of a distributed network including the posterior superior temporal sulcus (pSTS), the dorsal and ventral medial prefrontal cortices (dmPFC and vmPFC), ACC and posterior cingulate cortex (PCC), the amygdala, the orbital frontal cortex (OFC), and the fusiform gyrus (FG), TPJ, inferior occipital gyrus (IOG), and the insula. Each region serves distinct role while works together to support social processing, including perceiving, interpreting, and generating responses to the intentions, dispositions, and behaviors of others.",[28],{"date":480,"type":52},{"date":530,"type":52},"2021-01-01",{"date":532,"type":21},"2027-12-31",{"name":186,"class":59},{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":16,"minAge":540,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":22,"phases":543,"briefSummary":544,"conditions":545,"keywords":546,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":552,"locationsCount":98},"100506514","establish-the-couple-intervention-program-for-adults-with-autism-spectrum-disorder-100506514","NCT05875376","Establish the Couple Intervention Program for Adults With Autism Spectrum Disorder","Inclusion Criteria:\n\n* one person of each couple has either Autism Spectrum Disorder diagnosis or the autism spectrum quotient scoring above or equal to 26\n* able to communicate in Chinese\n* Wechsler Intelligence scoring above 70\n\nExclusion Criteria:\n\n* Psychiatric disorder (i.e. schizophrenia, substance abuse)\n* unable to communication (i.e. visual or auditory impairment)","20 Years","60 Years",{"count":169,"type":21},[110],"The development of adult intimate relationships and the transition into couplehood are part of most people's life cycles, but these transitions become very challenging for individuals diagnosed with autism spectrum disorder (ASD) in as much as social interactions, emotional communication, and reciprocity, which are essential for interpersonal relationships, are made more difficult due to the condition itself. In the Adult ASD Clinic of National Taiwan University Hospital, we observe that the wives of the ASD husband suffer from long-term frustration, loneliness and helplessness, and are frequently experience anxiety and depression, that in turns changes the family's function and impacts on children's mental health. To date, there are limited intervention models focusing on couple therapy for ASD adults (or neurodiverse couple). Given the strong needs of clinical service, this study aims to identify the common problems of the ASD couples and develop a program to improve their partner relationships.",[28],[547],"autism spectrum disorder, couple therapy",{"date":480,"type":52},{"date":550,"type":52},"2022-01-01",{"date":532,"type":21},{"name":186,"class":59},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":16,"minAge":419,"maxAge":540,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":566,"leadSponsor":568,"locationsCount":98},"100505166","social-skills-training-group-effectiveness-in-adolescents-with-autism-spectrum-disorder-100505166","NCT05857813","Social Skills Training Group Effectiveness in Adolescents With Autism Spectrum Disorder","Establishment of Social Skills Training Group in Adolescents With Autism Spectrum Disorder and Effectiveness Analysis","Inclusion Criteria:\n\n* aged 11-20 years, currently enrolled in school between the sixth grade of elementary school and the third year of high school\n* with a clinical diagnosis of ASD from a licensed mental health or medical professional based on DSM-5\n* experiencing social difficulties as reported by parents in a structured intake interview\n* scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD\n* demonstrating verbal fluency in Chinese\n* with a full-scale IQ \\> 70 on WAIS-IV\n* with motivation to participate in the intervention;\n* with a caregiver who was fluent in Chinese and willing to participate as a social coach in the study.\n\nExclusion Criteria:\n\n* a history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases that might hinder participation in the treatment\n* visual impairment and\u002For hearing impairment that would preclude participation in group-based social activities.",{"count":524,"type":21},[110],"Autism spectrum disorders (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and social interaction across multiple contexts, and the presence of restricted, repetitive behavior and interests, affecting 1 in 68 children. Although atypical social deficits onset in early childhood, their social relationships with peers may remain a challenge or even worsen for individuals with ASD throughout the school years and beyond, as social contexts increase in complexity and pose higher social expectations.",[28],{"date":480,"type":52},{"date":550,"type":52},{"date":567,"type":21},"2027-07-12",{"name":186,"class":59},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":16,"minAge":577,"maxAge":306,"enrollmentInfo":578,"targetDuration":4,"studyType":22,"phases":580,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":603,"locationsCount":124},"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":579,"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.",[583,29,28,584,585,586,587,588,589,590,591,592,593,594,595,596,426],"Neurodevelopmental Disorders","Fragile X Syndrome","Tuberous Sclerosis","22Q11 Deletion Syndrome","22Q11 Deletion","ADHD","Tic Disorders","Tourette Syndrome","Tourette Syndrome in Children","Tourette Syndrome in Adolescence","ADHD - Combined Type","ADHD Predominantly Inattentive Type","ADHD, Predominantly Hyperactive - Impulsive","Anxiety","2026-07-24",{"date":599,"type":52},"2026-07-27",{"date":601,"type":52},"2024-09-16",{"date":266,"type":21},{"name":604,"class":59},"Holland Bloorview Kids Rehabilitation Hospital",{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":16,"minAge":166,"maxAge":419,"enrollmentInfo":612,"targetDuration":4,"studyType":22,"phases":614,"briefSummary":615,"conditions":616,"keywords":618,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":629,"leadSponsor":631,"locationsCount":98},"100648899","clinical-trial-of-exploradores-de-sabores-to-improve-food-selectivity-in-asd-kids-100648899","NCT07727018","Clinical Trial of \"Exploradores de Sabores\" to Improve Food Selectivity in ASD Kids","A Clinical Trial of the \"Exploradores de Sabores\" Intervention to Improve Food Variety and Nutritional Status in Children With Autism Spectrum Disorder","Inclusion Criteria:\n\n* Children diagnosed with Autism Spectrum Disorder (ASD) requiring support levels 1, 2, or 3, without cognitive impairment.\n* Primary caregivers with sufficient availability to participate in and implement the intervention.\n* Children with or without mild functional gastrointestinal symptoms.\n* Children experiencing difficulties with the introduction or acceptance of new foods.\n* Children with clinically significant food selectivity, as determined by AUT-EAT\n* Children with malnutrition.\n\nExclusion Criteria:\n\n* Current use of medications known to substantially affect appetite or feeding behavior (e.g., cyproheptadine, clonidine, or other appetite-modifying medications).\n* Syndromic Autism Spectrum Disorder (ASD).\n* Clinically significant gastrointestinal disorders requiring active medical treatment.\n* Medical conditions that significantly affect nutritional status, growth, or feeding behavior (e.g., phenylketonuria, cystic fibrosis, inflammatory bowel disease, endocrine disorders, or eating disorders).\n* Cases in which the parent or legal guardian attending the training sessions is not the individual responsible for implementing the intervention activities with the child at home.",{"count":613,"type":21},72,[110],"The goal of this randomized, single-blind clinical trial is to evaluate the effectiveness of the Exploradores de Sabores parent-mediated nutrition intervention in reducing food selectivity and improving dietary variety, mealtime behaviors, nutritional status, and gastrointestinal symptoms among children aged 4 to 11 years with Autism Spectrum Disorder (ASD). The intervention consists of a standardized 15-week parent training program that combines nutrition education, behavioral feeding strategies, sensory-based approaches, and structured food exposure activities implemented by caregivers at home.\n\nThe main questions it aims to answer are:\n\n* Does the Exploradores de Sabores intervention improve food selectivity and dietary variety in children with Autism Spectrum Disorder compared with Education as Usual (EAU)?\n* Does the intervention improve mealtime behaviors, nutritional status, and gastrointestinal symptoms compared with Education as Usual (EAU)?\n\nResearchers will compare participants assigned to the Exploradores de Sabores intervention with those receiving Education as Usual (EAU) to determine whether the intervention results in greater improvements in food selectivity, dietary variety, mealtime behaviors, nutritional status, and gastrointestinal symptoms.\n\nParticipants will:\n\n* Complete study assessments at baseline and immediately after completion of the 15-week intervention.\n* Be randomly assigned to either the Exploradores de Sabores intervention or the Education as Usual (EAU) control group.\n* If assigned to the intervention group, caregivers will participate in a standardized 15-week parent training program and implement structured home-based feeding activities using the intervention manual and educational materials.\n* If assigned to the Education as Usual (EAU) control group, caregivers will receive 15-week parent training in general recomendations that include healthy meal planning, hydration, and general guidance for promoting balanced eating habits. Children will undergo assessments of food selectivity, dietary variety, mealtime behaviors, nutritional status, and gastrointestinal symptoms at each study visit.",[28,617],"Food Selectivity",[617,619,620,621,622,623,624,28,374,625],"Food Neophobia","Dietary Variety","Mealtime Behavior","Parent-Mediated Intervention","Nutrition Intervention","Nutritional Status","Gastrointestinal Symptoms","2026-07-23",{"date":599,"type":52},{"date":264,"type":21},{"date":630,"type":21},"2027-07",{"name":632,"class":59},"Universidad Autonoma de Baja California",{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":639,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":16,"minAge":70,"maxAge":4,"enrollmentInfo":641,"targetDuration":4,"studyType":22,"phases":643,"briefSummary":644,"conditions":645,"keywords":647,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":98},"100648446","feasibility-of-a-culturally-adapted-nurse-led-cope-intervention-for-caregivers-of-children-with-autism-spectrum-disorder-100648446","NCT07722949","Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder","Feasibility of Culturally Adapted, Nurse-Led COPE Intervention on Psychological Wellbeing of Primary Caregivers of Child With Autism Spectrum Disorder (CASD)","COPE-ASD","Inclusion Criteria:\n\n* Male or female primary caregivers aged 18 years or older.\n* Primary caregiver of a child with a confirmed diagnosis of Autism Spectrum Disorder (ASD).\n* Able to communicate in Urdu.\n* Willing and able to provide written informed consent.\n* Available to attend all intervention sessions and follow-up assessments.\n\nExclusion Criteria:\n\n* Caregivers currently participating in another structured psychosocial, behavioral, or parenting intervention.\n* Caregivers with a diagnosed severe psychiatric illness or cognitive impairment that would interfere with participation.\n* Caregivers unable to communicate effectively in Urdu.\n* Caregivers who decline or are unable to provide informed consent.\n* Caregivers who are unavailable to complete the intervention or follow-up assessments.",{"count":642,"type":21},77,[110],"This study aims to evaluate the feasibility of a culturally adapted, nurse-led Creating Opportunities for Parent Empowerment (COPE) intervention to improve the psychological wellbeing of primary caregivers of children with Autism Spectrum Disorder (ASD) in Pakistan. The study will use an exploratory sequential mixed-methods design comprising a qualitative needs assessment followed by a pilot randomized controlled feasibility trial. Qualitative interviews will identify caregivers' training needs and inform the cultural adaptation of the COPE intervention. Eligible caregivers will then be randomly assigned to either an intervention group receiving the culturally adapted COPE program in addition to routine care or a control group receiving routine care alone. The intervention consists of four weekly nurse-led sessions focusing on psychoeducation, cognitive restructuring, coping strategies, positive parenting, emotional regulation, and family resilience. Psychological wellbeing will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21) at baseline and one month after the intervention. The study will also evaluate recruitment, retention, intervention adherence, acceptability, and implementation feasibility to inform the design of a future definitive randomized controlled trial.",[28,646,115,596],"Psychological Distress",[28,648,649,650,651],"Caregivers","Psychological Wellbeing","Feasibility Trial","Randomized controlled trial","2026-07-20",{"date":626,"type":52},{"date":655,"type":52},"2026-07-15",{"date":657,"type":21},"2027-05-25",{"name":659,"class":59},"Khyber Medical University Peshawar",{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":4,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":16,"minAge":446,"maxAge":167,"enrollmentInfo":667,"targetDuration":4,"studyType":22,"phases":669,"briefSummary":670,"conditions":671,"keywords":672,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":98},"100648161","preliminary-effects-of-the-co-op-approach-in-children-with-autism-spectrum-disorder-100648161","NCT07717853","Preliminary Effects of the CO-OP Approach in Children With Autism Spectrum Disorder","Preliminary Effects of the Cognitive Orientation to Daily Occupational Performance Approach on Occupational Performance in Children With Autism Spectrum Disorder: A Pilot Study","Inclusion Criteria:\n\n* Having a clinical diagnosis of autism spectrum disorder\n* Being of primary school age\n* Having communication and cooperation skills sufficient to participate in the - Cognitive Orientation to Daily Occupational Performance intervention\n* Having at least one daily occupational performance goal identified by the child and\u002For family\n* Being able to attend the assessment and intervention sessions regularly\n* Provision of written informed consent by a parent or legal guardian\n\nExclusion Criteria:\n\n* Having a severe neurological, orthopedic, or psychiatric condition that may substantially affect the assessment or intervention process\n* Having severe behavioral difficulties that prevent safe and consistent participation in the intervention sessions\n* Having participated in an intensive, structured cognitive strategy-based intervention program within the previous 6 months\n* Withdrawal of the child or parent\u002Flegal guardian from the study",{"count":668,"type":21},10,[110],"Autism spectrum disorder may affect children's participation in daily occupations through difficulties related to motor planning, problem-solving, attention, behavioral regulation, and sensory processing. The Cognitive Orientation to Daily Occupational Performance approach is a goal-oriented intervention that supports children in identifying and using cognitive strategies to improve the performance of personally meaningful activities.\n\nThis pilot study aims to examine the preliminary effects of a 10-session Cognitive Orientation to Daily Occupational Performance intervention on occupational performance, satisfaction with performance, observed performance quality, and individualized goal attainment in primary school-aged children with autism spectrum disorder. Possible changes in autism-related behavioral characteristics and sensory processing patterns will also be examined.",[28],[28,673,177],"Cognitive Orientation to Daily Occupational Performance","2026-07-16",{"date":676,"type":52},"2026-07-21",{"date":678,"type":52},"2026-07-10",{"date":680,"type":21},"2026-09-30",{"name":682,"class":59},"Atlas University",{"id":684,"slug":685,"hasResults":12,"nctId":686,"briefTitle":687,"officialTitle":688,"acronym":689,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":16,"minAge":691,"maxAge":692,"enrollmentInfo":693,"targetDuration":4,"studyType":22,"phases":694,"briefSummary":695,"conditions":696,"keywords":700,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":708,"startDateStruct":709,"completionDateStruct":711,"leadSponsor":713,"locationsCount":98},"100648033","home-play-based-intervention-for-parents-and-infants-100648033","NCT07716072","Home Play-based Intervention for Parents and Infants","Sociometric Play-based Remediation of Individual Neurodevelopmental Trajectories (SPRINT)","SPRINT","Inclusion Criteria:\n\nAll participants must satisfy the following criteria:\n\n* Parent(s) must have access to the internet via a computer, laptop or phone.\n* Parent (s) with adequate English comprehension skills to participate in the study tasks and provide consent\n\nParticipants will be included if they meet either of the following criteria:\n\n\\- Parent(s) with infants who are identified as having increased familial risk of ASD, ADHD, GDD, related neurodevelopmental disorders or premature birth outcomes. Prematurity is defined as being born before 37 weeks.\n\nExclusion Criteria:\n\nParticipants will be excluded if they meet the following criteria:\n\n* Parent(s) and infants with brain injury, severe motor or sensory impairments (e.g., visual or hearing) that would render them unable to participate in the tasks\n* Parent(s) diagnosed to have impaired intellectual functioning or mental capacity.\n* Infants with an identified genetic, metabolic, syndromic, or progressive neurological disorder (e.g., epilepsy, Down or Rett Syndrome, Tuberous Sclerosis, Neurofibromatosis, Fragile X Syndrome), including vascular risk factors\n* Parent (s) with current or pre-existing diagnosed psychological conditions.","9 Months","15 Months",{"count":524,"type":21},[110],"The goal of this clinical trial is to learn whether a 12-week home-based intervention (Sociometric Play-based Remediation of Individual Neurodevelopmental Trajectories (SPRINT)) helps support parenting and the development of infants aged 7 - 15 months (at the time they join the study) who were born preterm and\u002For have a higher family risk of developmental conditions, such as autism spectrum disorder (ASD), attention-deficit\u002Fhyperactivity disorder (ADHD), and\u002For global developmental delay (GDD). The main questions it aims to answer are:\n\n* Does taking part in the SPRINT intervention help parents develop parenting skills?\n* Does taking part in the SPRINT intervention improve infant's thinking skills and\u002For socio-emotional development?\n\nResearchers will compare families who receive the SPRINT intervention with families in a waitlist control group to see whether the intervention leads to greater improvements in parents and their children.\n\nParticipants will:\n\n* Complete questionnaires and in-person assessments, before and after the 12-week period.\n* Be assigned to either the SPRINT intervention or a waitlist control group and complete the assigned activities for 12 weeks.\n* Use the SPRINT app, which provides information, guidance and activities for either the SPRINT intervention or waitlist control group.",[697,28,698,699],"Attention-Deficit\u002FHyperactivity Disorder (ADHD)","Premature Birth","Global Developmental Delay",[701,702,703,704,705,706,707],"Intervention","At-Risk Cohort","Play-based","Home","Social Emotional","Executive Function","Emotional Regulation",{"date":676,"type":52},{"date":710,"type":21},"2026-07",{"date":712,"type":21},"2030-03",{"name":714,"class":59},"Nanyang Technological University"]