Autism spectrum disorder

This study tests two approaches—lifestyle medicine consultations and cognitive behavioral therapy (CBT)—to reduce cardiovascular risk in autistic individuals aged 9 to 26 who have a high body mass index. Participants are randomly assigned to receive lifestyle coaching, CBT sessio…

This study will test whether living in a self-contained, AI-managed community (called a Microcity) can improve mental health and reduce addiction in adults with conditions like autism, ADHD, substance use disorders, and behavioral addictions. Up to 1 million participants will liv…

This study tests a brain implant called deep brain stimulation (DBS) to help six adults with severe aggression that hasn't improved with medication or other therapies. Participants have either autism or schizophrenia and live in locked psychiatric units. The implant targets a bra…

This study compares a semi-intensive therapy program (8 hours per week at a center plus online parent training) to the standard intensive program (15 hours per week) for young children with autism. The goal is to see if the remote approach works just as well for improving develop…

This study tests whether everolimus, a drug already approved for other conditions, can safely improve social abilities in people with PTEN Hamartoma Tumor Syndrome (PHTS). About 60 adults and children with PHTS and social difficulties will take either everolimus or a placebo for …

This study tests a short case management program for people who have been involuntarily admitted to a psychiatric hospital. The program, designed with input from people who have experienced coercion, provides up to five sessions with a nurse or social worker starting during the h…

This phase 2 trial tests a low-dose immune drug called interleukin-2 (ILT-101) in 22 children aged 6 to 8 with moderate to severe autism whose mothers had an autoimmune condition during pregnancy. The goal is to see if the drug can increase helpful immune cells (Tregs) and improv…

The ROOT study is testing a personalized nutrition program for pregnant women. Participants receive standard prenatal care plus customized diet and lifestyle plans based on their genes and nutrient levels. The goal is to see if this approach can lower the chances of preterm birth…

This study looks at whether a program called EMPOWER, led by trained peer supporters, can help homeless veterans with substance use or mental health issues stay engaged in care and avoid repeated hospital stays or emergency visits. About 278 veterans in permanent supportive housi…

This early-phase trial will test a new treatment called VGN-Ex05e, made from human embryonic stem cells, for children and teens with autism who have severe, treatment-resistant self-injury or aggression. The treatment is injected directly into a brain area linked to behavior. Onl…

This pilot study tests whether fecal microbiota transplantation (FMT) capsules can improve gut symptoms like constipation and diarrhea in children with autism, and possibly help their behavior. Twenty children aged 6-12 will be randomly assigned to receive either FMT capsules or …

This early-stage trial will test the safety of a single intravenous dose of stem cells derived from human bone marrow in 42 people aged 6 and older with autism spectrum disorder. Participants will receive one of three different doses. The study will monitor for side effects and a…

This study tests whether an AI-powered electric toothbrush and visual teaching materials can improve oral hygiene in children with autism. Fifty kids aged 5-13 will either use a manual toothbrush with picture guides or the smart toothbrush with an app. Researchers will check plaq…

This study tests whether a simple saliva swab can find genetic causes of neurodevelopmental or intellectual disorders when standard blood tests have not. Researchers will use advanced DNA sequencing on cheek cells from 50 participants. The goal is to improve diagnosis and help gu…

This study explores whether eye-tracking technology can help screen for autism in children aged 4 to 10. Researchers will compare how children with and without autism look at faces and other social cues. The goal is to develop a simpler diagnostic tool that doesn't require strong…

This study aims to validate a French translation of the SOSI-M test, which measures sensory integration in children. Researchers will film 60 children (30 healthy, 30 with mild to moderate neurodevelopmental disorders) taking the test and compare scores. The goal is to see if the…

This study will test a machine-assisted system that uses five simple behavioral tasks—like responding to their name or pointing—to screen toddlers for autism. Researchers will enroll 1,000 children aged 1.5 to 2.5 years, including those with autism, developmental delays, language…

This study tests a language intervention called Milieu Teaching-AV for infants aged 6-12 months who have an older sibling with autism, putting them at higher risk for autism or language delays. The intervention encourages babies to look at caregivers' faces and mouths during play…

This Phase 3 study tests whether a combination of two drugs, KarXT and KarX-EC, can safely reduce irritability in children and adolescents aged 5 to 17 with autism spectrum disorder. About 176 participants will receive either the drug combo or a placebo for 8 weeks. The main goal…

This study tests whether a new medication, KarXT + KarX-EC, can reduce irritability in children and teens (ages 5 to 17) with autism. About 176 participants will receive either the drug or a placebo. The main goal is to see if the drug improves irritability scores after 8 weeks.

This study will test whether a wearable device called Apollo Neuro is practical and acceptable for autistic children aged 6 to 14 who hurt themselves. The device delivers low-intensity vibrations through the skin. For about a month, 18 children will wear it at least 3 hours a day…

This study tests whether virtual reality (VR) exercises can improve attention, memory, and thinking skills in children with autism aged 4 to 6. Thirty children will be split into two groups: one using VR training and the other using traditional paper-and-pencil activities. The go…

This study tests whether ganaxolone, a drug already approved for certain seizures, can reduce irritability in autistic children aged 5 to 17. About 66 participants will receive either the drug or a placebo for 12 weeks. The main goal is to see if it improves emotional regulation …

This study will test a behavioral program to improve sleep and daily rhythms in autistic teenagers aged 13-17 who have sleep problems. The goal is to see if the program is practical and helps teens sleep better, which may also improve their mood and thinking. The study involves 1…

This early-stage study tests whether a non-invasive ultrasound device aimed at a deep brain region can safely improve social skills in people with autism. Twenty participants aged 13 to 25 will receive the treatment and be monitored with brain scans and behavior tests. The goal i…

This early-phase trial tests whether the steroid prednisone can improve core autism symptoms in 32 adult males with an immune-mediated subtype of autism. Participants take prednisone or a placebo daily for 16 weeks, with regular check-ins and questionnaires. The goal is to see if…

This study tests whether photobiomodulation (a type of light therapy) can improve core autism symptoms like social interaction, communication, and behavior in 30 children aged 2 to 6. Participants will receive standard therapies plus light therapy. Researchers will measure change…

This study tests whether a type of cognitive training called Action-Based Cognitive Remediation (ABCR) can improve thinking skills in people with various psychiatric conditions like depression, schizophrenia, anxiety, PTSD, and autism. Participants will complete computer exercise…

This study compares two well-known early autism interventions, ESDM and PRT, to see which one helps young children with autism improve their communication skills more. Researchers will enroll 140 children aged 2 to 5 and randomly assign them to one of the two therapies for 24 wee…

This study tests a program called MENU that gives caregivers of young children (ages 2-5) practical tools while they wait for an autism evaluation. The program is tailored to each family's needs and includes strategies to improve caregiver mental health, child communication, and …

This study will test a new occupational therapy program in schools for children aged 6 to 14 with Autism Spectrum Disorder or Intellectual Disability. The program focuses on improving sensory processing and daily living skills through weekly 50-minute sessions over 10 to 12 weeks…

This study tests a short, guided self-help program designed to help parents of autistic children aged 6-17 feel less stressed and more compassionate toward themselves. About 6-8 parents will use a workbook and audio tracks, plus get weekly support calls over 13 weeks. The goal is…

This study tests a behavioral program called TranS-C to help autistic adults with sleep and circadian problems. The program teaches regular sleep routines, daytime habits, and helpful sleep beliefs. Researchers will enroll 24 autistic adults to see if the treatment improves overa…

This study looks at whether a therapy called Acceptance and Commitment Therapy (ACT) can help fathers of children with special needs feel more flexible in their thinking and improve their mental health. About 50 fathers will take part, with half getting ACT and the other half rec…

This study tests an investigational drug called Omega-DEK plus L-carnitine in 34 children aged 3 to 6 with childhood apraxia of speech (CAS). The study lasts 20 weeks and first gives everyone the treatment, then randomly assigns some to a placebo to see if the treatment helps mai…

This early study tests whether inhaling a gas called xenon for 10 minutes a day over 10 days can improve social functioning in children with autism. 72 children aged 4-18 will receive either xenon or a placebo. Researchers will check social skills right after treatment and again …

This study tests whether toe spread-out exercises, with or without walking on different surfaces, can improve foot arch support and jumping ability in children with autism who have flatfoot. Thirty-four children aged 7 to 12 will do the exercises three times a week for eight week…

This study tests whether buspirone, a medication used for anxiety, is safe and effective for autistic youth aged 7 to 17 who also have anxiety disorders. Researchers will measure changes in anxiety symptoms over 16 weeks. The goal is to see if this drug can ease anxiety in this s…

This study tests a program that combines a daily digital game for children aged 5-8 with autism and weekly online coaching for their parents. The goal is to improve executive functions like self-control, memory, and flexibility. Researchers will measure changes using computer tas…

This study tests whether playing a virtual reality game called Electrical Maze can improve sustained attention in neurodivergent children aged 9 to 18, including those with autism, ADHD, or learning differences. Over 6 weeks, 40 participants will play the VR game twice a week for…

This study tests a new visual safety plan designed for autistic teenagers who have had suicidal thoughts or self-harm. About 90 teens aged 13-18 will be randomly assigned to either get the visual plan plus usual care, or just usual care. The goal is to see if the plan is easy to …

This study tests a mobile app called 'Heart Voice: Starry Journey' designed to help parents and caregivers of children with autism feel more flexible and less anxious or depressed. About 52 caregivers will use the app for 6 weeks, doing interactive stories and exercises based on …

This study tests whether a non-invasive brain stimulation technique called rTMS can reduce symptoms of ADHD and autism in children and teens aged 6-19. Participants will receive either real or sham (fake) stimulation over three weeks. The goal is to see if it is safe and if it im…

This study tests a structured lifestyle program for mothers who are the primary caregivers of children with autism. The program includes eight sessions over four weeks, focusing on stress management, healthy routines, and balancing daily activities. Researchers want to see if thi…

This study tests a rhythmic auditory training program designed to help children with Autism Spectrum Disorder (ASD) improve their language skills. 24 children aged 3 to 6 with a formal ASD diagnosis and language delay will practice reproducing the syllable rhythms of speech. Rese…

This study will test whether a device called NeuroCytotron, which sends low-energy magnetic pulses to specific brain areas, can safely improve social communication and reduce repetitive behaviors in children with autism. 256 children aged 3 to 12 will be randomly assigned to rece…

This study tests two ways to deliver a group training program for caregivers of children with autism in low-resource areas. The program aims to reduce caregiver stress and improve the child's communication and behavior. About 320 caregivers of children aged 2 to 8 will take part.…

This study tests whether a full-spectrum cannabis plant extract called NTI164 can help reduce core autism symptoms (like social challenges and repetitive behaviors) in children and young adults aged 6 to 25. About 98 participants will receive either NTI164 or a placebo for 16 wee…

This pilot study will test whether a program called Facing Your Fears can help reduce anxiety in 24 children aged 12-18 who have both autism spectrum disorder and intellectual disability. The program uses cognitive behavioral therapy techniques like gradual exposure to feared sit…

This study tests whether the PEERS® program, a social skills training from the US, can help Italian teens aged 10-14 with autism make and keep friends. Thirty-six teens will either take the program or continue their usual care. Researchers will measure changes in social knowledge…

This early-stage study tests a group program called HEART for autistic adolescents aged 13 to 18. The program focuses on improving how teens understand and regulate their emotions. Researchers will check if the training is practical and helpful, using parent questionnaires to mea…

This study tests a version of the RUBI parent training program that has been adapted for Spanish-speaking families of autistic children aged 2 to 9. About 120 parents will join eight online group sessions to learn practical strategies for managing challenging behaviors. Researche…

This early-phase trial tests whether giving adults with autism a 6-week course of vancomycin followed by a fecal transplant from a close relative can improve social and language problems. Ten participants will be tracked for changes in autism symptoms, quality of life, and gut he…

This study tests a behavioral program called KF-STRIDE that helps autistic adults recognize their strengths and talk about them appropriately in job interviews. Thirty participants will practice in mock interviews and be rated by experts. The goal is to see if the program is prac…

This study tests a new program called CapExchange, where people with stable mental health conditions exchange practical skills with others in their community. The goal is to see if this approach is practical and helpful for improving well-being and social connection. About 10 to …

This study tests a mobile health program called FANS-EI that aims to support caregivers of young autistic children in staying engaged with early interventions. Researchers will measure caregiver comfort, participation, and sense of support. The study involves 28 caregiver-child p…

This study aims to adapt and validate a French version of the Recovery Assessment Scale (RAS), a questionnaire that measures how people feel about their own recovery from mental health conditions. Researchers will ask 260 adult psychiatric patients in France to fill out the RAS a…

This study compares how well teens with autism spectrum disorder (ASD) drive compared to neurotypical teens. Researchers will use a driving simulator and a real road test to measure errors, visual attention, and anxiety. The goal is to understand differences in driving performanc…

This study will test whether using results from a sensory integration assessment can improve counseling for children aged 3-12 with neurodevelopmental problems like sensory sensitivity or coordination difficulties. Researchers will measure changes in sensory processing and daily …

This study looks at how the tiny organisms in the gut (the microbiome) are connected to brain development and daily skills in children with autism. Researchers will collect stool samples and measure movement, thinking, and behavior in 600 children aged 3 to 12. The goal is to bet…

Researchers at the University of Haifa are studying the ankles and Achilles tendons of 80 adults with autism to see if structural differences relate to sensory responsiveness and toe walking. Participants will undergo ultrasound and strength tests. This observational study aims t…

This observational study looks at 200 children aged 4-12 with autism to see if trunk control (balance and stability) explains why some have lower exercise capacity. Participants do a trunk control test and a 6-minute walk during a single clinic visit. No treatment is given—the go…

This study looks at whether a guided self-help workbook can help autistic adults feel better. Ten participants will use the workbook with a trained supporter over 4-6 sessions. They will fill out wellbeing questionnaires and share their thoughts in interviews. The goal is to see …

This study aims to collect blood samples from 450 people, including individuals with autism spectrum disorder (ASD), their relatives, and healthy controls. Researchers will isolate cells from the blood to study genetic factors and biological processes linked to autism. The goal i…

This pilot study will test whether autism can be diagnosed in toddlers (16-36 months) using a telehealth protocol, instead of an in-person visit. Researchers will enroll 100 children from Georgia's early intervention program who are at moderate or high risk for autism. The goal i…

This study aims to create a therapy program using Acceptance and Commitment Therapy (ACT) for fathers of children with special needs in Hong Kong. Researchers will interview 20 fathers and social workers to understand their challenges and what kind of support would help. The goal…

This study looks at using simple, low-cost communication tools like picture boards and gestures for children with autism who have trouble speaking. It involves 500 children and their caregivers in rural Virginia and western Kenya. The goal is to find better ways to match each chi…

This study looks at how emotional regulation varies across the menstrual cycle in autistic women. Researchers will compare them to women with borderline personality disorder, premenstrual dysphoric disorder, and those without any diagnosed condition. The goal is to better underst…

This study tests whether adding a career counseling program called Purposeful Pathways to standard job training helps veterans with mental health and substance use disorders find and keep quality jobs. About 254 veterans from three VA sites will take part. The goal is to improve …

This study is looking for early clues—like brain activity, genetics, and environment—that might predict autism, ADHD, and related mental health issues in children and young adults. Researchers will follow 800 participants from infancy through young adulthood across 10 internation…

This study gives 40 adults—half with autism, half without—a single dose of MDMA (the active ingredient in ecstasy) or a placebo to see how it changes oxytocin levels in the blood. Oxytocin is often called the 'love hormone' and helps with social bonding. The goal is not to treat …

This study tests a new computer-based training program designed to help autistic children ages 8-11 improve their thinking and problem-solving skills. The goal is to see if this training can reduce repetitive behaviors and improve daily functioning. 95 children will be randomly a…

This study will use a digital platform with game-like tasks to measure thinking and reading skills in 300 children aged 3-11 who are suspected of having a neurodevelopmental disorder. The goal is to create detailed cognitive profiles before a formal diagnosis, helping to identify…

This pilot study will develop and test a toolkit that helps therapists tailor mental health treatment for autistic individuals. Researchers will first hold focus groups to understand barriers, then create a resource for therapists. The toolkit will be tested with 18 autistic teen…

This study tests a new training program called CIPP-A for pediatric providers who care for autistic youth at risk of suicide. About 70 providers will be randomly assigned to learn either the new program or a standard safety planning approach. Researchers will measure how often pr…

This study looks at how the brains of children with Williams syndrome and autism differ, focusing on social and thinking skills. Researchers will compare 75 children aged 3-12 from three groups: those with Williams syndrome, those with autism, and typically developing kids. No tr…

This study aims to understand the biological causes of autism by growing tiny 3D brain models called organoids from cells of people with autism. Researchers will compare these organoids to those from siblings without autism to see how genetic differences affect brain cell develop…

This study will test a tool called the Health Improvement Profile (HIP) in a mental health inpatient unit. The HIP is a checklist that helps clinicians spot physical health problems like high blood pressure or poor diet in people being treated for mental illness. Researchers will…

This study will follow 120 Mandarin-speaking children with autism and typically developing children to understand how speech develops over time. Researchers will use parent reports and play sessions to track language skills. The goal is to create models that help predict speech p…

This study looks at how people with mild intellectual disability process emotions compared to those with autism and typically developing individuals. It also tests a special therapy program to help them regulate emotions. 40 people with intellectual disability will take part in t…

This study looks at whether a parent training program can help autistic toddlers (ages 12-36 months) learn to manage their emotions. Researchers will work with 40 families and early intervention providers to see if the program is practical and helpful. The goal is to improve supp…

This study will follow 15 people aged 5 to 50 with 7q11.23 microduplication syndrome, a rare genetic condition linked to autism and social difficulties. Researchers will track developmental milestones, social skills, and behavior using interviews and questionnaires. The goal is t…

This observational study will monitor brain activity (EEG) in 330 people during anesthesia or sedation to see how it relates to drug levels and patient factors. It includes children with and without autism, adults over 70, and adults having sedation for endoscopy. The goal is to …

This study looks at whether training primary care clinicians to diagnose autism in children aged 18 to 36 months can shorten the time from a positive screening to a final diagnosis. About 300 children will take part across multiple clinics. Researchers will compare diagnosis time…

This study looks at 48 teenagers with autism who were checked for psychotic symptoms 10 years ago. Researchers want to see how their mental health and daily functioning are now. They will compare those who had early signs of psychosis with those who did not, using interviews and …

This study aims to better understand psychiatric disorders, thinking problems, and treatment side effects in 2000 cancer patients and their close relatives. Researchers will compare those with and without mental health issues to find patterns and improve care. No new treatments a…

This study looks at how children with autism spectrum disorder (ASD) process visual information over very short time intervals. Researchers will use eye-tracking tasks to measure how quickly children with ASD can integrate separate images into one and how fast they can shift atte…

This study looks at whether adding decoding and encoding practice to the ALLSTAR literacy program helps children with complex communication needs learn to read better. Sixty children aged 5-12 who use augmentative and alternative communication (AAC) will be split into two groups:…

This study looks at how adolescents with autism handle stress, anxiety, and depression compared to teens without autism. Researchers will use questionnaires and interviews to understand coping strategies. The goal is to find better ways to support mental health in teens with auti…

This study tests an online program for 40 caregivers of children aged 7–12 with autism in South Korea. The program helps parents think through and prepare for telling their child about the diagnosis. Researchers will check if the program is helpful and easy to use, and if it impr…

This study will check how much psychiatric clients know about occupational therapy (OT) and whether their expectations are realistic. It will also evaluate how well OT interns explain health information and conduct interviews. Researchers will develop new tools to measure these s…

This study looks at whether chemicals and other substances in a mother's body during pregnancy can help predict if her child will develop autism. Researchers will use stored urine and cord blood samples from 600 first-time mothers. The goal is to build a model that could estimate…

This study will test a mobile app called ¡Iniciando! designed to help Latino young adults with autism and their families navigate the move to adulthood. The app includes virtual group sessions and coaching over 12 weeks. The goal is to see if the app is easy to use, acceptable, a…

This study tests two different approaches for bringing autistic people and Applied Behavior Analysis (ABA) providers together to discuss research priorities. One approach uses a restorative justice framework to ensure autistic voices are heard and respected. The goal is to find b…

This study looks at 27 children with autism to see if how they process sensory information is related to tightness in their ankle muscles, which can cause toe-walking. Researchers will measure ankle flexibility and have parents fill out a detailed questionnaire about their child'…