Clinical Trials for Autism Spectrum Disorder

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Autism Spectrum Disorder from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 19
• Active, not recruiting: 8
• Completed: 15
• Other: 8

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT00271622 — The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.

NCT01778504 — Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders

Background:

- Many psychiatric, behavioral, and developmental disorders are genetic. This means that they tend to run in families. Some begin in childhood, while others do not appear until adulthood. Researchers want to look at people of all ages who have these disorders that started in childhood. They will also look at relatives of people with these disorders. This information will allow doc…

NCT03866668 — A Study of Esomeprazole in Children With Autism

Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive/stereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 chil…

NCT04026386 — A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders…

NCT05035511 — A Machine Learning Approach for Predicting tDCS Treatment Outcomes of Adolescents With Autism Spectrum Disorders

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behaviors. Particularly detrimental are the presence of restricted and repetitive stereotyped behaviors and uncontrollable temper outbursts over trivial changes in the environment, which often cause emotional stress for the children, their families, sc…

NCT04631042 — Developing Brain, Impulsivity and Compulsivity

Background:

Impulsivity 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.

Objective:

To learn about genetic & brain feature…

NCT04899544 — Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism

The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are recei…

NCT05803343 — Evaluating Additive Effects of Including Canines in Regulating Together

The primary objective is to evaluate the potential additive effect of animal-assisted intervention (AAI) on a manualized behavioral treatment targeting emotion dysregulation (ED) in children with autism spectrum disorder (ASD).

Aim 1: Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating Together-Standard.

Aim 2: Eval…

NCT05681923 — Platform for the Prospective Mother-child Study of the Determinants of Neurodevelopmental Disorders

Neurodevelopmental disorders such as attention deficit disorder with or without hyperactivity, autism spectrum disorder, language and social communication disorder, motor coordination disorder, learning disorder (dyslexia, dyscalculia, dysorthography), intellectual development disorder are frequent and long-lasting developmental difficulties that can be observed in children in various domains. …

NCT06229210 — Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

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.

NCT06362733 — Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of paren…

NCT06690398 — Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and …

NCT06706674 — Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and …

NCT06203938 — Autism Research Project With Non-Invasive Near-Infrared Light Stimulation

The investigators have previously shown that the administration of low-level infrared light is a safe and non-invasive procedure which improves cognition and emotion, as well as enhances brain metabolic activity. Based on previous studies, the investigators hypothesize that this methodology, called low-level light therapy or photobiomodulation, could be used to improve behavioral symptoms in in…

NCT07021274 — DBT Skill Training for Autistic Adults With Difficulties in Emotion Regulation.

One in 44 has autism, 70% of them have additional mental health challenges. Currently, this patient population does not have access to effective treatment within specialist healthcare services and has struggled to benefit from standard treatments. The goal of this project is to increase access to treatment tailored to their challenges. We will investigate whether a treatment program with an ada…

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively

NCT07476937 — Differences in Rest, Emotion, and Arousal Modulation in Youth

The goal of this study is to examine the relationship between sensory responsivity, bedtime arousal levels, sleep disturbances, and daytime emotion dysregulation for autistic children (ages 6-10). In a subset of children with elevated sensory responsivity, a sensory-based bedtime manipulation targeting bedtime arousal levels will be tested.

NCT06690255 — Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder

The goal of this clinical trial is to understand if an online course in Spanish can help Spanish-speaking parents use Pivotal Response Treatment (PRT) to support language and social skills in young children with Autism Spectrum Disorder (ASD). This study aims to reach families who may have trouble accessing autism services due to language, location, or cost barriers. The main questions it hopes…

NCT07642661 — A Placebo-controlled Trial of Folinic Acid in Children With ASD

Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by difficulties in social communication and the presence of restricted or repetitive behaviors. Although behavioral and educational interventions can be helpful, there is currently no established medication for the core symptoms of ASD. Medications approved for associated irritability may be effective in some childre…

Active, Not Recruiting

NCT01160783 — Genetic Contributions to Autism Spectrum Disorders

This study is working towards gaining a better understanding of the genetic and environmental factors involved in autism spectrum disorders (ASD), which includes autism, pervasive developmental disorder (PDD), and Asperger’s syndrome. The investigators hope that information gained from this study will lead to new ways of diagnosing and treating ASDs.

NCT01260961 — Developing Treatment, Treatment Validation and Treatment Scope in the Setting of an Autism Clinical Trial

Dr. Sherie Novotny of the Department of Psychiatry at UMDNJ-RWJMS and collaborators are starting a treatment trial to determine whether Docosa Hexanoic Acid(DHA), the major omega-3 fatty acid found in the brain and a component of fish oil, has any effects on the symptoms of autism.

We propose to carry out a trial to test the effect of DHA compared to a placebo (a pill with no drug in it) on se…

NCT06431126 — Nature and Animal-assisted Activities

Neuropsychiatric impairments in young adults are common and can involve social withdrawal, and difficulties in receiving support from healthcare and municipal social care services. Collaboration is needed, but knowledge gaps exist concerning effective interventions. Participation in meaningful activities, as a complement to other treatment strategies can be a step towards studies/work. The aim …

NCT05114538 — Improving the Part C Early Intervention Service Delivery System for Children With ASD

Despite strong consensus that early, specialized intervention for children with autism spectrum disorder (ASD) can have a dramatic impact on outcomes, the public health system’s capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to increase timely and equitable access to ASD-specialized early intervention during the…

NCT06438536 — STEPS: A Virtual Reality-based Intervention for Adults With Autism.

The goal of this clinical trial is to learn if a new Virtual Reality-based intervention will be effective in treating social cognitive challenges in adults with autism.

The main questions it aims to answer are:

1. Is Virtual Reality-based social cognitive training effective in reducing social cognitive deficits and improving psychosocial functioning, quality of life, and clinical symptoms in …

NCT06596226 — Evaluating Pathways Mutual Gaze Protocol on Social Skills in Young Children Suspected of Autism

Purpose of the Study: The goal of this clinical trial is to find out if a technique called the “mutual gaze procedure,” used in Pathways Early Intervention (Pathways), is the key to helping improve social communication, language, and everyday skills in young children (16-30 months old) who are at high risk for autism, particularly those from diverse cultural and language backgrounds.

What Will…

NCT06537128 — Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety

Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to ca…

NCT07670000 — Mental And Speech Developmental Delay Autism Spectrum-Type Behavioral Disorder

FAMILY SYSTEM CITADEL 2060.METHODOLOGY “VOICE OF SLEEP MAMABEE 2026-2085 Systemic work with brain neurons through training modules at the border of sleep in clinical, psychological and strategic logic. Training modules of fairy tale in brain simulation, restoration of the nervous system core in real time. Strategic model of the generational horizon: 2nd, 3rd, and 4th generations.

AUTONOMOUSLY….

Not Yet Recruiting

NCT07687381 — AI-Based Reflective Parenting Simulation for Parents of Autistic Children

This randomized controlled trial evaluates an AI-based parental simulation designed to support reflective parenting, emotional regulation, and parent-child communication among parents of autistic children aged 3 to 12 years. A total of 140 parents will be recruited through an external online survey platform and randomly assigned to an intervention group or a control group. The intervention grou…

NCT07500363 — Improving Caregiver Engagement in Early Interventions

The goal of this study is to test the effectiveness of the FANS-EI program in supporting caregiver engagement in caregiver-mediated early interventions for young children with autism. This study also examines caregiver-perceived social support and self-efficacy and FANS-EI implementation outcomes (feasibility, acceptability, appropriateness).

NCT07673172 — A Two-Part Intervention to Target Cardiovascular Health

Obesity is one of the most common health conditions among autistic young people and its prevalence rises at faster rates for autistic-relative to non-autistic-individuals. This places them at heightened risk for cardiovascular disease (CVD) and mortality before they enter adulthood. Studies have identified three key contributing factors to CVD outcomes in autistic individuals: unhealthy lifesty…

NCT07661823 — QAIAx (AIhealth4U) - AI Public Health Central: Microcity-A (re Quantum AI Agency Aka AI City Hall Project, UPSTO App Nos. 64/074,526, 64/063,557, 63/903,181, 63/729,428

BRIEF SUMMARY

A. “What is the purpose of this study?”

This study will test whether the “AI City Hall Project” (QAIAx), a quantum artificial intelligence (AI) public health agency, can provide free or low-cost behavioral and mental health services inside self-contained, dome-enclosed communities called “Microcities”. Researchers want to see if AI-managed public administration, AI humanoid robo…

NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

NCT07522190 — Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism

The goal of this study is to compare two well-established early autism interventions, Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT), to better understand which approach is most effective for improving communication skills in young children with autism and which children may benefit most from each treatment. Additionally, after completing either the ESDM or PRT, some parti…

Enrolling by Invitation

NCT07667023 — Virtual Reality Headset as an Alternative Tool for Reducing Dental Anxiety

The aim of this study is to investigate whether the use of virtual reality (VR) headsets can have a positive effect on dental fear during dental procedures and stress induced by the dental environment. Particular attention is paid to children with mild intellectual disabilities and those living with neurodevelopmental disorders (autism spectrum disorder), for whom these factors may hinder the s…

Completed Trials

NCT02628808 — Susceptibility Genes in Autism Spectrum Disorders

The main objective of the study is to define, for Autism Spectrum Disorder, the extent of genetic variation in synaptic pathways that may be targeted for therapeutic development. For this purpose the investigators will take advantage of large, well-characterized cohorts of patients with Autism Spectrum Disorder for genetic screenings. Targeted sequencing of selected synaptic genes, previously a…

NCT01031407 — Cognitive Neuroscience of Autism Spectrum Disorders

Background:

• Autism spectrum disorders (ASDs) are a group of developmental disorders that affect communication, social interaction, and behavior. Relatively little is known about the relationship between genetics and behavior among these individuals and their close relatives. Researchers are interested in using interviews and rating scales to better understand these issues, as well as collect…

NCT03778827 — A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism

The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (ASD).

NCT03835117 — Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder

The objective of this study is to evaluate the metabolic effects of a comprehensive wide-spectrum supplement for children with ASD to determine whether it physiologically targets mitochondrial pathways known to be abnormal in children with ASD.The intervention is a commonly used wide-spectrum nutritional supplement, which is theoretically designed to normalize mitochondrial function. The invest…

NCT04089579 — hCT-MSC in Children With Autism Spectrum Disorder

The purpose of this Phase II study is to determine the efficacy of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) for improving social communication abilities in children with autism spectrum disorder (ASD).

NCT04660552 — Transcranial Photobiomodulation for Reducing Autism Symptoms in Children

The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 6, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 8 weeks. Results will be measured through parental interviews, standardized CARS2 (…

NCT05344378 — Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism

This project, Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement with Mental Health Services for Youth with Autism (ATTAIN NAV) is focused on adapting and implementing family navigation in primary care settings to help accelerate and facilitate engagement in mental health and community services for children with autism and their families.

NCT06359080 — Transcranial Photobiomodulation for Reducing Autism Symptoms in Children - Open Label Study (TPBMASDOL)

The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 7, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 10 weeks. Results will be measured through parental interviews, standardized CARS2 …

NCT06207149 — Adapting an Advocacy Services Intervention for Latinx Families of Transition-aged Youth With Autism Spectrum Disorder

When youth with autism spectrum disorder (ASD) transition from school to adult services, they fall off a “service cliff.” To increase access to services, the investigators developed the ASSIST program, which teaches parents how to advocate for adult services on behalf of youth with ASD. In a pilot randomized controlled trial (RCT: R34 MH104428), treatment group (versus control) participants dem…

NCT07678333 — Effectiveness of a Virtual Reality Social Skills Intervention in Autism

The goal of this clinical trial is to evaluate whether the MyRAKAN Autism module, which integrates video modelling and spherical video-based virtual reality (SVVR), can improve social communication skills in autistic young adults.

The main questions it aims to answer are:

Does the MyRAKAN Autism module improve social responsiveness and social communication skills in autistic young adults? Doe…

NCT05862467 — A Pilot Participatory Program Evaluation of a Virtual Trauma Support Program for Autistic Adults

The goal of this single-group clinical trial is to learn about the initial efficacy and feasibility of telehealth-delivered Written Exposure Therapy (WET) for autistic adults with traumatic stress symptoms. The main questions the investigators aim to answer are:

• Do symptoms of posttraumatic stress disorder (PTSD) and co-occurring mental health concerns decrease after receiving WET?
• Do biob…

NCT06592404 — The (Cost)Effectiveness of a Social Robot for Persons With Problems in Daily Structure and Planning in Disability Care

The goal of this multiple baseline single case study is to study the (cost)effectiveness of a social robot in reducing professional caregiver support and promoting independence for individuals in long-term disability care experiencing problems with daily structure and planning. The main research questions it aims to answer are:

• What is the effect of the social robot on the frequency of momen…

NCT06110884 — Music Therapy for Language and Social Skills in Autistic Children

This research is a single-blind randomized controlled trial, where the investigators plan to recruit 40 children with autism, randomly divided into two groups. The music therapy intervention group will receive an hour of group music therapy in addition to traditional language therapy. The control group will receive only traditional language therapy. The trial will last for 8 weeks, and particip…

NCT06375226 — Autism and Attachment. An Explorative Study of Attachment Styles in Autistic Adults.

The present study examines the relationship between attachment and autism spectrum disorder (ASD) in adults.

NCT06591130 — Culturally Adapted Intervention to Prevent Self-harm in Young People With Autism

The goal of this feasibility randomized controlled trial is to assess the feasibility and acceptability of Youth Culturally Adapted Manually Assisted brief psychological intervention (YCMAP) in young people with autism in Pakistan. In a rater-blind, 2-arm, multi-site, feasibility randomized controlled trial (RCT), participants will be randomized either to 1) YCMAP added to the Treatment as Usua…