Autism Disorder

15

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

Condition / disease
Location
Status: Not yet recruiting

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 robots, holoportation of human-figures via 'holo-suites' (e.g., AI-119 Kikkeri Holo-Suit; AI-119 Vulcan QM-Ware) and advanced AI mental-health tools can lower housing and care costs, improve mental health outcomes (e.g., particular ecosystems using AI tools among persons with one or more addiction disorders), and be financially sustainable for people on fixed incomes or public assistance. B. "What conditions does the study focus on?" The study focuses on adults with: * Autism spectrum disorders (Asperger's, autism, ADHD, ASD) * Substance use disorders (alcohol, opioids, marijuana, cocaine, MDMA/ecstasy, tobacco/nicotine) * Psychiatric conditions (personality disorders, narcissism, gender dysphoria, eating disorders) * Behavioral addictions (gambling, sex addiction) and related issues (sex offence history). C. "What does the study involve?" Eligible volunteers live in an omni AI-managed Microcity for up to 24 months. The community is housed in a geodesic dome that contains all daily necessities: housing, food, utilities, healthcare, and public services. Daily life is managed by an AI system (ISAC) and AI humanoid robots, with only occasional human oversight. Participants receive free mental-health treatment that may include AI-driven counselling, virtual-reality therapy (holo-suits), and non-invasive digital "attitude inoculation" protocols designed to reduce stress and addiction cravings. All participants also take AI-technology courses as a condition of enrolment. The study does not use any FDA-regulated drug, device, or biologic. \*\*Who can participate?\*\* You may be able to join if you: * Are an adult (18 years or older) * Have a diagnosis of one of the listed mental-health or addiction disorders * Are referred by a licensed health professional (e.g., RN, NP, PhD, MD), a non-profit organisation (e.g., 501(c)(3), university, church), or a public agency (e.g., case manager, social worker, parole/probation officer, judge) * Are willing to live in a closed, AI-managed community for up to one year and complete AI educational courses. Participants who are veterans, receive public assistance (e.g., VA disability, SSDI/SSI, Medicaid, Medicare), or are experiencing homelessness may be prioritised. \*\*Where is the study taking place?\*\* The study will be conducted at Microcity sites in the United States and internationally. The first administrative site is in Richmond, Virginia, USA. Additional sites are planned in partner nations, including tribal lands, military installations, and special economic zones. \*\*Who is sponsoring the study?\*\* The study is sponsored by \*\*Veterans Recovery Network Inc.\*\*, a non-profit organization, in collaboration with \*\*AI-119 Vulcan Project Research \& Educational Technology Co. (PRETCO)\*\* and an AI legal agency. The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §129a) and is part of a Cooperative Research and Development Agreement (CRADA) with U.S. Special Operations Command (USSOCOM). This summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.

Participants needed: 1,000,000
Trial details
Age: 17-99Biological sex: AllType: InterventionalSponsor: Veterans Recovery Network Inc.Updated: Jun 22, 2026Locations: 1
Eligibility criteria

Individuals aged 17 to 99 years old. [+3]

Status: Not yet recruiting

Achilles Tendon and Ankle Characterization in Adults With Autism

This study aims to identify ankle structural and functional profiles associated with sensory responsiveness and toe walking in adults with ASD. Expected outcomes include detecting group differences between adults with ASD and matched controls and identifying associations among sensory responsiveness, toe-walking status, and objective ankle measures.

Participants needed: 80
Trial details
Age: 18-40Biological sex: AllType: ObservationalSponsor: University of HaifaUpdated: Jun 11, 2026
Eligibility criteria

a diagnosis of ASD, or with another diagnosis that includes features of ASD (suc... [+4]

other neurological diseases (e.g., CP, multiple sclerosis), [+4]

Status: Not yet recruiting

GENES AND AUTISM - Induced Pluripotent Stem Cells

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social interaction and verbal and non-verbal communication (DSM-5, 2013), affecting approximately 2% of the general population. In 5 to 40% of cases, genetic factors are identified as the cause of these disorders, with prevalence depending on the technique used (exomes and/or SNP arrays) and the associated intellectual deficit. In the majority of cases, the etiology remains unknown. Studies of microdeletions/microduplications (copy number variants) or Whole Exome Sequencing and Whole Genome Sequencing (Single Nucleotide Variants) show the involvement of numerous genes in the predisposition to autism. ASD remains a genetically heterogeneous disorder, as more than 250 genes have been associated with ASD to date. The main objective of the project is to continue identifying genetic factors, and also to understand the biological mechanisms involved in the emergence of autistic symptoms. Identifying biological pathways is an essential step in developing new therapeutic strategies. In addition, one of the major challenges of this study is to better understand the phenotype/genotype relationships in ASD. This requires in-depth knowledge of the phenotypic characteristics of participants with ASD and their families, as well as neurotypical populations. This study combines the scientific expertise of researchers specializing in molecular biology, phenotypic exploration (clinical, cognitive, MRI, EEG, biochemistry, immunology), and the use of pre-therapeutic cellular models (iPSCs, neural precursors, organoids). The objective of this work is the identification of numerous genes associated with ASD and involved in synaptic formation and regulation: NLGN3-4, SHANK1 and SHANK3, CNTN-6, and CNTNAP4. This work was combined with in-depth phenotypic explorations of ASD participants and their relatives. It has made it possible to clarify the neuroanatomical characteristics of participants with ASD and their genetic substrate, as well as the underlying cognitive processes. All of this work opens up new prospects for identifying new therapeutic targets using preclinical cell models (IPSCs Induced pluripotent stem cells, neural progenitors, organoids) developed in particular by I-Stem and Human Technopole.

Participants needed: 450
Trial details
Age: 2+Biological sex: AllType: InterventionalSponsor: Institut National de la Santé Et de la Recherche Médicale, FranceUpdated: Jun 5, 2026Locations: 1
Eligibility criteria

1) Be Included in the "Genes and Autism" protocol (C07-33 or C16-89). [+21]

For all participants [+13]

Status: Recruiting

Piloting the Competence in Romance and Understanding Sexual Health Curriculum

The goal of this clinical trial is to learn whether the CRUSH curriculum is possible (feasible), whether it fits the needs of the adults it is designed for (acceptable), and shows initial signs of being helpful (efficacious). CRUSH is a group-based behavioral intervention plus 1-1 coaching designed to provide sexual education and improve the skills of autistic adults for intimate relationships. The main goals of the project are to: * Evaluate the feasibility and acceptability of the CRUSH curriculum in the context of a clinical trial with a waitlist control condition. * Initial exploration of how the CRUSH curriculum works and whether it is helpful. Participants will complete: * A screening call. * Confirmation of clinical characteristics (autism features, language ability, cognitive ability). * 3 visits to assess knowledge and behaviors related to dating and sexual health at each point throughout the training curriculum (before beginning, midway, and after finishing). * 20 sessions of the CRUSH curriculum plus 1-1 coaching sessions. After each session, provide feedback about the session.

Participants needed: 40
Trial details
Age: 18-30Biological sex: AllType: InterventionalSponsor: Boston Children's HospitalUpdated: Apr 24, 2026Locations: 1
Eligibility criteria

18;0 to 30;11 years old; [+3]

Non-English-speaking participants (less than 50% of speech in English); [+6]

Status: Not yet recruiting

Research on the Molecular Mechanism of Cognitive Differences Between Williams Syndrome and Autism Spectrum Disorder

Williams Syndrome (WS) is a rare neurodevelopmental disorder, usually caused by microdeletions of approximately 26 genes in the long arm (7q11.23) region of chromosome 7. Children with this syndrome often exhibit distinctive facial features, mild to moderate intellectual disability, impaired spatial cognition, pronounced social extraversion, and relatively reserved language-expression characteristics. Although individuals with WS often demonstrate strong social interest and prosocial behaviors, significant deficiencies in abstract thinking, executive function, and visuospatial ability are frequently observed. At present, treatment for WS mainly focuses on behavioral intervention and educational rehabilitation, and clear molecular or pharmacological treatment methods remain limited. Due to the "opposite but related" social-cognitive profile observed in comparison with autism spectrum disorder, in-depth exploration of neural and molecular mechanisms underlying these differences has substantial scientific significance for understanding the biological basis of social-cognitive impairment.

Participants needed: 75
Trial details
Age: 3-12Biological sex: AllType: ObservationalSponsor: Qilu Hospital of Shandong UniversityUpdated: Apr 3, 2026Locations: 1Duration: 1 Month
Eligibility criteria

Age 3-12 years old. [+8]

For the Williams Syndrome group: Known or suspected presence of other pathogenic... [+3]

Status: Not yet recruiting

CFT Guided Self-help Intervention: Parents of Autistic Children

This research will aim to test how practical, achievable and effective a brief, guided, self-help compassion focused intervention is for parents of autistic children aged 6-17 years old. The demands of parenting can be rewarding but also challenging, and it is known that parents of autistic children experience additional pressures. As a result of this, parents of autistic children may be more likely to experience increased stress, anxiety, low mood and lower quality of life, compared to those parenting children who are not autistic. There has been only a small amount of research so far regarding whether interventions that focus on building compassion, would be beneficial to parents of autistic children. The purpose of this study is to test whether a short, self-guided compassion-focused intervention is practical, achievable and effective for parents of autistic children. The intervention is based on Compassion Focused Therapy (CFT) and involves reading workbook material and listening to audio tracks. There will also be some questionnaires to complete and 30-minute weekly support calls with the lead researcher. This intervention was adapted previously, from an intervention for parents in general, to be more suitable and focused on the needs of parents of autistic children. This study will be the first time the adapted intervention has been used by parents. The intervention will be tested by 6-8 parents and will be about 13 weeks long. We will collect some demographic data at the start of the study, and there will be the opportunity to complete an evaluation questionnaire.

Participants needed: 8
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of NottinghamUpdated: Mar 27, 2026Locations: 1
Eligibility criteria

Participants must be a parent who lives with their autistic child. The parent mu...

Those who are currently receiving psychological or mental health input from prof...

Status: Recruiting

Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders

Recent research links gut microbiota alterations to Autism Spectrum Disorders (ASD), a neurobiological condition with multifactorial bases. In some ASD patients, altered gut flora and increased intestinal permeability are observed, influencing the central nervous system's development and function. Chronic gastrointestinal (GI) symptoms are commonly associated with ASD and correlate with its severity. This non-pharmacological interventional clinical study aims to investigate the role of gut microbiota on ASD and the effectiveness of postbiotic-based dietary supplements in children aged 3-8 years old. Gastrointestinal symptoms, behavioral profile and analysis of intestinal metagenomic and metabolomic profiles will be assessed before and after one-month treatment. The results of the study could enhance understanding of non-pharmacological therapeutic approaches in ASD and improve clinical management strategies and the behavioural functioning for children with ASD.

Participants needed: 90
Trial details
Phase: Phase 2, Phase 3Age: 3-8Biological sex: AllType: InterventionalSponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUpdated: Mar 4, 2026Locations: 2
Eligibility criteria

Diagnosis of ASD according to DSM-5 diagnostic criteria; [+6]

Exclusion Criteria [+5]

Status: Not yet recruiting

Follow-up of Adolescents With Autism and Psychotic Symptoms - Psychiatric Co-morbidity and Functional Impairment.

Purpose: To describe level of function, psychotic and psychiatric symptoms in a 10-year follow up of individuals with autism and psychotic symptoms. Method: A case-control study based on a cohort of 48 teenagers with autism established 2013. In the original study, 22 participant reported psychotic symptom in self-evaluation questionnaires design for early detection. We aim to recruit these individuals and controls from the same cohort without psychotic symptoms. Data will be collected from self-rating scales, clinical evaluation including semi-structured interviews and healthcare journals. The study is primarily descriptive, with group comparison by non-parametric method.

Participants needed: 48
Trial details
Age: 25-35Biological sex: AllType: ObservationalSponsor: Värmland County Council, SwedenUpdated: Feb 23, 2026
Eligibility criteria

Not listed

Status: Recruiting

Using Virtual Reality to Improve Emotion Understanding in Children With Autism

Autism Spectrum Disorders (ASD) are neurodevelopmental conditions characterized by difficulties in social interaction, communication, and in understanding one's own and others' mental and emotional states. In particular, skills related to the recognition, understanding, and regulation of emotions represent a significant area of vulnerability in children with high-functioning ASD, with important consequences for social and relational functioning. The present study aims to evaluate the effectiveness of an intervention protocol designed to enhance socio-emotional understanding, with a specific focus on the recognition of basic and complex emotions, the expansion of emotional vocabulary, the association between situations, thoughts, and emotions, and the differentiation between thoughts and emotions. Furthermore, the study seeks to investigate the role of immersive technology (Oculus) as a potential facilitator of emotional learning compared to a traditional intervention approach. The sample will consist of children with a diagnosis of high-functioning ASD, aged between 7 and 10 years, with sentence-level language abilities, the capacity to narrate non-present events, and an intellectual quotient above 80 (assessed using the Griffiths Scales or the WISC-IV). Participants will be divided into two groups: an experimental group (OCULUS), which will receive the intervention mediated by the use of Oculus technology, and a control group which will undergo the same protocol without technological support.

Participants needed: 30
Trial details
Age: 7-10Biological sex: AllType: InterventionalSponsor: Istituto per la Ricerca e l'Innovazione BiomedicaUpdated: Jan 26, 2026Locations: 1
Eligibility criteria

Language in sentences [+2]

presence of other medical disorders

Status: Not yet recruiting

How Virtual Reality Can Help Neurodivergent Children Improve Their Attention

The goal of this study is to determine whether playing a virtual reality (VR) game can help neurodivergent children pay attention for extended periods. The study includes children ages 9 to 18 who have autism, ADHD, learning differences, or movement coordination challenges. The program lasts for 6 weeks. During this period, children will play a VR game twice per week, with each session lasting 25 minutes.

Participants needed: 40
Trial details
Age: 9-18Biological sex: AllType: InterventionalSponsor: New York Institute of TechnologyUpdated: Jan 14, 2026Locations: 1
Eligibility criteria

Clinical diagnosis of ASD, ADHD, SLD, or DCD confirmed by a licensed clinician o... [+5]

History of photosensitive epilepsy or any uncontrolled seizure disorder. [+4]

Status: Recruiting

Impact and Determinants of Success of a Mobile Multidisciplinary Intervention System Specialized in Pain Management for Patients With Moderate to Severe Intellectual Development Disorder, Isolated or Associated With an ASD or Multiple Disability

Pain is described by patients with a Neurodevelopmental Disorder (NDD), including Autism Spectrum Disorder (ASD), Intellectual Development Disorder (IDD) or multiple disabilities, and the family as one of the main associated disorders; its management is also one of the main concerns of families and professionals. At present, there is no validated and tested pain management system in populations facing complex pain situations. In response to the lack of a pain management services, a multi-disciplinary mobile team was set up in September 2022 at the Brest University Hospital (Mobile Pain Handicap Team Intellectual Disability 0-25 years; MoDIDol). This team offers a specific protocol for the assessment and management of pain that takes into account the social and family environment, the living context and the clinical characteristics of patients (children, adolescents and young adults (0-25 years) with IDD, ASD or multiple disabilities). The team includes at least one paediatrician specialising in the assessment and treatment of pain and a nurse, and travels to patients' usual living environments.

Participants needed: 80
Trial details
Age: Up to 24Biological sex: AllType: InterventionalSponsor: University Hospital, BrestUpdated: Dec 24, 2025Locations: 1
Eligibility criteria

Aged from birth up to 24 years inclusive (i.e., under 25 years old) [+6]

More than three places of residence and/or care settings [+1]

Status: Not yet recruiting

NTI164 in Autism Spectrum Disorder

This is a double-blind, randomised, placebo-controlled study investigating the efficacy of a full-spectrum medicinal cannabis plant extract on core and associated ASD symptoms over placebo. Participants will be randomly allocated to either NTI164 or placebo at a 1:1 ratio and blood samples will be collected and surveys completed at baseline and Week 16. This study will expand efficacy and safety data of NTI164 and provide additional mechanism of action data of NTI164 in this patient cohort.

Participants needed: 98
Trial details
Phase: Phase 3Age: 6-25Biological sex: AllType: InterventionalSponsor: Fenix Innovation GroupUpdated: Dec 2, 2025Locations: 1
Eligibility criteria

Participant is aged 6 years to 25 years (inclusive). [+7]

Current diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective... [+18]

Status: Not yet recruiting

The Intervention of Lactobacillus Plantarum Probiotics in Adult Autistic Spectrum Disorders

This is a qualitative and quantitative mixed-methods, open-label study, will involve 12 participants and their caregivers. Participants will also undergo blood exams and gait analysis, while caregivers will complete qualitative interviews and quantitative questionnaires on autistic symptoms, stress, anxiety, and quality of life. After the baseline assessments, participants will receive Lactobacillus plantarum for 8 weeks, followed by further evaluations at end point.

Participants needed: 12
Trial details
Age: 18-50Biological sex: AllType: InterventionalSponsor: Mackay Memorial HospitalUpdated: Aug 12, 2025Locations: 1
Eligibility criteria

Those who have been diagnosed with autistic spectrum disorder aged 18~50 years o... [+2]

Have taken antibiotics or are receiving antibiotic treatment within one month. [+7]

Status: Recruiting

Using Technologies to Promote HEalthy Lifestyles in Adolescents With Intellectual Disabilities

IDHEApp will implement various educational technology tools and work with the families, teachers and caregivers to increase physical activity (PA) and improve healthy eating. Due to the current COVID-19 pandemic restrictions, the use of innovative digital technology can contribute not just to distance learning but also to support families and students in remote. However, both healthy habits and technologies are insufficiently addressed in the population with IDD. These needs are in line with the following objectives of the Erasmus+ programme: a) Inclusion and diversity in all fields of education, training, youth and sport; b) Addressing digital transformation through development of digital readiness, resilience and capacity, and c) Encouraging the participation in sport and physical activity. Educators will find innovative possibilities and the right instruments that will enable them to fulfil their potential through innovative online education \& learning \& training skills module for lifestyle promotion and others available on the app. Furthermore, mentors and others health professionals (e.g., nursing etc.) will be equipped with knowledge and skills on how to use the app to teach practical skills for PA enhancement in an evidence-based way. Consequently, this project will contribute to \[specific objectives - SO\]: \- Raise awareness of the importance of healthy and active living among young Europeans with intellectual disabilities. Different workshops and bigger events (i.e., international conference), together with the involvement of numerous participants from the institutions of this consortium will be ensured. Further, a sensitized community will participate through the social networks and the website itself, in the proposed activities. \- Provide digital resources and tools to the partner entities of the exchange to improve lifestyle of young people with intellectual disabilities. Best Practices to provide high quality, inclusive digital health education with the best educational technology tools and methodology. A website, a mobile app and different electronic guidelines will be delivered. \- Analyze the current state of use and acceptance of technologies as support in the management of health in adolescent with intellectual disabilities.

Participants needed: 60
Trial details
Age: 4-30Biological sex: AllType: InterventionalSponsor: University of SevilleUpdated: Aug 7, 2025Locations: 1
Eligibility criteria

Diagnosis of intellectual disability [+2]

presence of severe sensory or motor impairments [+2]

Status: Recruiting

Rural Autistic Individuals - Supporting Expression

This research study investigates how hand gestures can support language comprehension and communication skills of hearing speaking, non-speaking, and/or minimally verbal individuals with Autism Spectrum Disorders (ASD), who are especially disadvantaged by the lack of accessible services in their rural communities. Individuals with other cognitive profiles, including Developmental Language Disorder (DLD), ADHD, Dyslexia, and others are welcome too. The study uses methods of eye tracking and recording of brain activity to understand how hand gestures adapted from signs from American Sign Language, such as \[cry\], can promote successful understanding of words like "cry". The overarching goal is to help families effectively utilize gestures to support communication with their children.

Participants needed: 50
Trial details
Age: 2+Biological sex: AllType: InterventionalSponsor: Montana State UniversityUpdated: Jul 10, 2025Locations: 1
Eligibility criteria

1.1 Confirmed (preferably) or suspected diagnosis of ASD (autism spectrum disord...

1. Poor hearing. 2. Inborn or acquired brain damage.