Autism Spectrum Disorder Clinical Trials

Multisite 14-week prospective double-blind placebo controlled parallel-group randomized clinical trial with 14-week open-label extension at the end of double-blind treatment phase for placebo subjects. Eligible subjects will be randomized within each site in 2:1 ratio to receive either TB006 or placebo treatment. Read Less

The goal of this observational study is to test a reciprocal relationship between statistical learning and the development of language and literacy in first-graders with autism and their non-autistic peers. The main questions it aims to answer are: 1. whether children's statistical learning abilities can predict their long-term improvement of language and literacy skills in school; 2. how children's brains automatically learn patterns from speech and prints; 3. whether children's learning in the lab reflects the language patterns they have learned over the years from their native language. First-grade students will participate in the study twice across three months. During Time 1, children will complete * a battery of language, reading, and cognitive assessments * a series of computer-based statistical learning games both inside and outside of functional MRI scanner. During Time 2, children will complete a battery of language and reading assessments to detect the growth in three months. Researchers will compare the autistic and the non-autistic groups to see if statistical learning plays a similar or different role in predicting children's language and literacy growth. Read Less

The goal of this study is to determine the impact of neuromodulation to the cerebellum on social and executive functions in neurotypical young adults and young adults with autism. Read Less

This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care. Read Less

The goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using N-acetylcysteine (NAC), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. The findings from this research will shed light on the mechanisms of action underlying the clinical benefits of NAC. Read Less

The goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using N-acetylcysteine (NAC), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. The findings from this research will shed light on the mechanisms of action underlying the clinical benefits of NAC and the effects of NAC on altering restricted and repetitive behavior symptom severity in children with autism spectrum disorder. This is a 12-week double-blind, randomized, placebo-controlled trial of NAC. Read Less

The investigators are looking to evaluate how effective a strength-based intervention may be in improving job interview skills in young adults. The investigators are examining the effects of this intervention in young adults who may have difficulty with job interviews, and who may want to improve these skills. Read Less

There is an urgent need for improved access to effective autism treatments. With advances in technology, distance learning models have particular promise for families who cannot access evidence-based parent training locally or may be on long wait-lists for behavioral treatments. Pivotal Response Treatment (PRT) is an established treatment for autism spectrum disorder (ASD); however, a telehealth PRT model has not yet been evaluated in a controlled trial. This study will examine the effects of training parents in PRT via secure video conferencing and investigate 1) whether parents can learn via telehealth to deliver PRT in the home setting (PRT-T) and 2) whether their children will show greater improvement in functional communication skills compared to children in a waitlist control group. Participants will include 40 children age 2 to 5 years with ASD and significant language delay. Eligible children will be randomly assigned to either PRT-T (N=20) or waiting list (N=20). Weekly 60-minute parent training sessions will be delivered for 12 weeks via secure video conferencing software by a PRT-trained study therapist. The effects of PRT-T on parent fidelity of PRT implementation, child communication deficits including frequency of functional verbal utterances, and parent-report of communication skills on standardized questionnaires will be evaluated. This research will provide a foundation for wider dissemination of technology-based solutions to improve access to ASD treatment. Read Less

For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions. Read Less

The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with ASD. Read Less

School-based behavioral approaches to managing challenging behaviors in children with ASD are limited by three key factors: 1) children with ASD often have difficulties communicating their emotions; 2) it is challenging to implement evidence-based, personalized strategies for individual children, and; 3) it is difficult for teachers to track which strategies are successful for individual children. The investigators' personalized mobile-health emotion regulation application (m-health app) will pair heart rate tracking with digital tools to help reduce challenging behavior by supporting stress detection, reminding teachers of specific behavioral strategies and helping teachers to track progress. Read Less

Autistic adults are at a greater risk for mental health problems compared to the general population, with 50% meeting criteria for a co-occurring psychiatric condition. Depression and anxiety are the most common of these conditions among autistic adults, contributing to long-term detrimental effects on health, day-to-day functioning, and quality of life. This study will conduct the first large-scale head-to-head comparison of the two most widely studied mental health interventions for autistic adults: cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT). Both interventions are well-established, empirically supported treatments for depression and anxiety in the general population, and both interventions have demonstrated efficacy among autistic adults. However, their comparative effectiveness and heterogeneity of treatment effects have not been established in autistic adults. Both interventions will be delivered by telehealth. Read Less