Autism Spectrum Disorder Clinical Trials

The primary objective of this study is to evaluate the cognitive and behavioral effects of liquid leucovorin calcium on young children with autism spectrum disorder (ASD) and determine whether it improves social communication as well as the core and associated symptoms of ASD. The investigators will enroll 80 children across two sites, between the ages of 2.5 and 5 years, with confirmed ASD and known social and communication delays. Participation will last approximately 26 weeks, from screening visit to end of treatment. Read Less

The purpose of this research study is to investigate the effects of transcranial direct current stimulation (tDCS) on some of the challenges faced by children with Autism Spectrum Disorder (ASD). Read Less

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin on bone health in children with autism spectrum disorder, ages 6-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (30 IU, 2 times daily) for 12 months in the double-blind phase, followed by a 6-month open label phase during which all study subjects will receive intranasal oxytocin (30 IU, 2 times daily). Study visits include screening to determine eligibility, followed by study visits at baseline, week 2, and months 6, 12, 18 and phone calls every two weeks for the first two months and monthly thereafter for the duration of the study. Study assessments include history and physical examinations, anthropometric measurements, electrocardiogram (EKG), adverse event monitoring, laboratory tests for chemistries, hormones and biomarkers for bone metabolism, questionnaires regarding diet and exercise, and imaging to assess body composition, bone density and structure. Read Less

The goal of this clinical trial is to learn about the journey of families after their child's diagnosis of autism and to help parents understand autism and get the right treatments for their child. This study is for parents of children just diagnosed with autism who are: Age greater than 1 and up to 5 years old; Hispanic/Latino OR Black/African-American OR have Medi-Cal as primary health insurance; AND Live in one of the following counties in California (Alameda, Contra Costa, Marin, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa Clara, Santa Cruz, Solano, or Sonoma). The main questions it aims to answer are: Whether parent coaching through Project AFECT leads to decreased parental stress and increased parental confidence; Whether family navigation through Project AFECT leads to increased number of referrals to early intervention and educational services and reduced wait times to autism treatments; Whether children whose parents receive Project AFECT intervention show increased language skills compared to children whose parents did not receive intervention. Participants will be asked to: Complete surveys at enrollment and 3 and 6 months later. Work with Project AFECT Coach. Researchers will compare control and intervention groups to see if Project AFECT leads to improved parent and child outcomes. Read Less

This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD. Read Less

This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in youth with Non-Verbal Learning Disorder, High-Functioning Autism Spectrum Disorder, and related conditions. Eligible participants will be males and females ages 8-18. This study consists of up to 6 visits to Massachusetts General Hospital. Read Less

Background: Creatine transporter deficiency (CTD) is a genetic disorder that mainly affects the brain in males. CTD causes intellectual disability that can be mild to severe. People with CTD may have seizures and behavioral issues. They may have slow growth and tire easily. CTD may sometimes be confused with autism or other disorders. Better diagnostics are needed. The study team in an NIH study noted that the faces of children with CTD can look similar. For this natural history study, an expert will examine photos of children with CTD. Any shared traits found might help to diagnose CTD. Objective: To look for shared facial features of children with CTD. Eligibility: Males aged 2 to 40 years old with CTD who were in study 17-CH-0020. Design: Some participants in study 17-CH-0020 had pictures taken of their faces. The NIH study team wants to share these photos with a colleague in Canada. This person is an expert at evaluating how genetic disorders affect people s bodies. Participant data collected during the study may also be sent to this expert. This data may include diagnostic images and results from lab tests. Some children did not have their pictures taken during study 17-CH-0020. Parents are asked to take pictures of these children and send them to the study team. These photos can be sent to a secure portal. The photos can also be taken in-person during a clinic visit. The photos may be printed in clinical study journals. But this is not required. Parents will be asked to sign a separate consent before the photos are published. Read Less

The goal of this clinical trial is to learn about the feasibility and acceptability of a behavioral intervention in designed to provide sexual education and improve the behavioral skills of autistic adults for intimate relationships. The main questions it aims to answer are: Acquire feasibility and acceptability data for delivery of the CRUSH curriculum in a group didactic setting plus 1-1 coaching. Acquire feasibility and acceptability data regarding the assessment battery for future clinical trials. Participants will complete: A screening call. Provide documentation of a diagnosis of autism spectrum disorder. 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). 15-20 training sessions to participate in the CRUSH curriculum. After each session, provide feedback about the session. Read Less

The goal of this randomized clinical trial is to test whether the 6 sessions HEARTS Healthy Relationships classes increases the satisfaction that autistic adults feel about their friendships and dating relationships compared to a 6 weeks online discussion group. The 6 HEARTS sessions cover: healthy and unhealthy relationships, launching new relationships, neurohealth, meeting and reconnecting, boundaries, and healthy endings. Participants who take part in this research study will be in this research study for three months. During this time, participants will be asked to complete two 30-minute and six 10-minute online surveys, and participate in two 20-minute interviews over Zoom. Read Less

The purpose of this study is to examine the effectiveness of virtual reality (VR) delivered exposure therapy for youth with phobias or social anxiety, with and without autism spectrum disorder. The study team is also interested in collecting information to better understand phobias and social anxiety. Read Less

The purpose of this research use only (RUO) study is to detect genomic structural variants (SVs) in human DNA by Optical Genome Mapping (OGM) using the Bionano Genomics Saphyr system. SVs are a type of genetic alternation that includes deletions, duplications, and both balanced and unbalanced rearrangements (ex: inversions or translocations), as well as specific repeat expansions and contractions. The results of OGM analysis will be compared to prior clinical genetic test results to determine how OGM compares to current standard of care (SOC) clinical test methods such as chromosomal microarray analysis (CMA), karyotyping, Southern blot analysis, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), and/or next generation sequencing (NGS), etc. Read Less

The goal of this clinical trial is to learn about occupational therapy integrating horses for autistic youth. The main questions it aims to answer are: Does occupational therapy integrating horses improve self-regulation in autistic youth Does occupational therapy integrating horses affect salivary cortisol and alpha-amylase Participants will receive 10 weeks of occupational therapy, and will be asked to provide saliva samples each week. Researchers will compare occupational therapy integrating horses to occupational therapy in a clinic to see if integrating horses affects self-regulation. Read Less