Autism Spectrum Disorders

7

Review clinical trials related to Autism Spectrum Disorders. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

A Comparative Study of Driving Performance Among Adolescents With Autism Spectrum Disorder and Neurotypical Adolescents

The primary objective of this study is to compare the number of driving errors made by novice adolescents (0-5 hours of driving instruction) with ASD to those made by neurotypical adolescents during a standardized driving simulator assessment. The secondary objectives of the study are to: * Compare the visual strategies used by adolescents with ASD to those of neurotypical adolescents during a driving assessment on a simulator. * Compare the types of errors and driving performance (i.e., speed, reaction time, following distance, and braking distance) of adolescents with ASD to those of neurotypical adolescents during the driving simulator assessment. * Compare the driving performance of these two groups during a real-world road assessment using the TRIP scale. * Examine the consistency between driving performance measured in the simulator and that observed in real-world conditions for both groups. * Compare the anxiety levels of these two groups during driving tests on the simulator and on the road.

Participants needed: 22
Trial details
Age: 15-17Biological sex: AllType: InterventionalSponsor: Hopital La MusseUpdated: Jun 17, 2026Locations: 1
Eligibility criteria

Adolescents aged 15 to 17, [+11]

Adolescents with ADHD (attention-deficit/hyperactivity disorder) and/or ODD (opp... [+5]

Status: Recruiting

Single Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active/Stable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th

study with arbaclofen (4 weeks of titration and then 6 weeks of active/stable treatment). The effects of arbaclofen on target EEG and ERG metrics will be associated with the clinical response in measures of social and general function, adaptive behaviour, social anxiety, sensory behaviours, global functioning, and quality of life in Children and Adolescents with Autism Spectrum Disorders

Participants needed: 103
Trial details
Phase: Phase 3Age: 0-64Biological sex: AllType: InterventionalSponsor: Hospital General Universitario Gregorio MarañonUpdated: Jun 17, 2026Locations: 5
Eligibility criteria

Signed Written Informed Consent a.Participants or their legal representative mus... [+10]

Participants with any condition that might interfere with the conduct of the stu... [+13]

Status: Not yet recruiting

Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder

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: * How does prednisone affect the core features and associated target symptoms of ASD in adults with an immune-mediated subtype of ASD? * Is prednisone safe for autistic adults without causing too many side effects? * Does this study warrant larger trials studying anti-inflammatory drugs in this subject population? Researchers will compare the drug prednisone to a placebo (a look-alike substance that contains no drug) to see how prednisone affects autistic adult males. Participants will: * Visit the clinic 2 times for a screening and baseline visit. * Take prednisone or a placebo every day for 16 weeks. * 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. * Provide blood and urine samples for testing up to 4 times. * Complete 8 remote calls every 1-2 weeks for checkups and dose changes. * Keep a diary of the dose and times they take the study drug every day and any symptoms or side effects they experience.

Participants needed: 32
Trial details
Phase: Early Phase 1Age: 18-50Biological sex: MaleType: InterventionalSponsor: Christopher John McDougle, M.D.Updated: May 12, 2026Locations: 1
Eligibility criteria

18 to 50 years of age (inclusive) and assigned male at birth. [+12]

DSM-5-TR diagnosed ASD, level 1, or presence of another DSM-IV-TR diagnosed perv... [+16]

Status: Recruiting

Pilot Study on Collaborative, Comprehensive, Multidimensional and Quality of Life Tools for Priority Definition, Shared Decision Making, Outcome Evaluation and Quality of Care Improvement in ASD Individuals and Programs in the Real World.

ASD is a very complex and lifelong disorder. Patients' functioning is influenced by multiple factors, including treatments, inclusion and life contexts. Nonetheless, outcome measures are still point-specific and highly fragmented, rarely considering global or multidimensional functioning, development or long-term modifications, especially in the real world. The present study considers ongoing real-life treatments in three different NHS settings, in line with the Italian Guidelines. Two age classes will be considered, 0-5 and 6-11, adding new outcome tools pre-post intervention to those already used, to evaluate quality of life, global functioning, multidimensional needs and strengths and shared decision making. Correlations between the different outcome tools will be explored, and possible clusters will be investigated. Acceptability of the outcome tools for the operators, patients and families, as well as usefulness and sustainability in daily practice, will also be evaluated.

Participants needed: 400
Trial details
Age: 0-11Biological sex: AllType: ObservationalSponsor: Antonella CostantinoUpdated: Feb 20, 2026Locations: 3Duration: 12 Months
Eligibility criteria

ASD diagnosis according to the criteria shared by the regional NFA network [+2]

Subjects aged 12 years or older at the time of enrollment [+1]

Status: Recruiting

Water Competency Intervention in Autism

AquOTic is an evidence-based, occupational therapy-led intervention designed to enhance water competency and swim safety skills in children on the autism spectrum. The 10-week program consists of weekly 60-minute group sessions, each including six children paired in a 1:1 ratio with an interventionist. Sessions follow a structured routine involving six rotating stations, targeting various swim and safety skills, with the flexibility for individualized support by the interventionist. Overall, this study has 3 major aims. The first aim evaluates the effectiveness of the AquOTic intervention in improving water competency and swim skills, while comparing outcomes between two implementation models: professional student interventionists (occupational and physical therapy students) and trained community-based interventionists. A total of 108 autistic children will be enrolled and randomly assigned to one of three groups: (1) AquOTic with professional student interventionists, (2) AquOTic with community interventionists, or (3) a control group receiving no AquOTic intervention. The second aim explores the mediators and moderators of the intervention outcomes to assess fidelity and efficacy. The third aim identifies the cost and resources associated with AquOTic. A cost analysis will be conducted to evaluate the resources required for implementation and to inform the development of a scalable, cost-effective drowning prevention strategy for autistic populations.

Participants needed: 108
Trial details
Age: 5-9Biological sex: AllType: InterventionalSponsor: Ohio State UniversityUpdated: Dec 4, 2025Locations: 1
Eligibility criteria

Educational or medical diagnosis of autism [+2]

Children who demonstrate swim proficiency, as defined by the ability to tread wa... [+9]

Status: Recruiting

Intestinal Permeability in Children With Autism Spectrum Disorder

In recent years, increasing attention has been directed toward the role of the gut-brain axis in the pathogenesis of neurodevelopmental disorders, particularly Autism Spectrum Disorder (ASD). Among the multiple contributing factors, the integrity of the intestinal barrier appears to play a crucial role. Enhanced paracellular permeability ("leaky gut") may allow luminal antigens and microbial metabolites to translocate into the systemic circulation, triggering inflammatory responses that could impact neuropsychological functioning. Several studies suggest that, although intestinal permeability is not universally altered in all individuals with ASD, there exists a subset characterized by selective epithelial dysfunction, especially associated with repetitive and stereotyped behaviors. This project aims to investigate, through a controlled sibling-based design, whether intestinal permeability indices are significantly altered in children with ASD and whether such alterations are specifically correlated with behavioral domains assessed through the ADOS instrument.

Participants needed: 55
Trial details
Age: 2-14Biological sex: AllType: ObservationalSponsor: University of BariUpdated: Jun 27, 2025Locations: 1
Eligibility criteria

Children with a clinical diagnosis of ASD according to DSM-IV, confirmed by ADOS... [+3]

Known neurological disorders. [+5]

Status: Recruiting

Development and Application of a Diagnosis and Treatment System for Children's Brain Diseases Based on Knowledge Graphs and Large Models

Using the knowledge graph and big model technology of combining Chinese and Western medicine we construct a popularization and prevention system for childhood encephalopathy an assisted decision-making system for childhood encephalopathy and a follow-up tracking question and answer system for childhood encephalopathy patients.

Participants needed: 2,000
Trial details
Age: 2-18Biological sex: AllType: ObservationalSponsor: Yun Liu,PhDUpdated: Feb 27, 2025Locations: 1Duration: 2 Months
Eligibility criteria

1. meet diagnostic criteria for CP ID TD ADHD ASD; 2. gender is not limited;

1. CP ID TD ASD due to chorea hepatomegaly hearing abnormality and pharmacogenet... [+1]