Autism Paid Clinical Trials in California

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, or intellectual disability. Read Less

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 receiving treatment as usual (TAU). Read Less

This is a multicenter study that aims to determine whether the EEG and ET experiments studied in the ABC-CT Phase 1 and ABC-CT Confirmation studies can be successfully used with 3-5-year-old children and to determine the viability of these measures as potential biomarkers in 3-5-year-old children with ASD. Blood (DNA) samples will be collected from participants with ASD and biological parents for future genomic analyses, and raw, processed, and analyzed data will be shared to create a community resource accessible for use by all qualified investigators. These objectives are designed to advance the long term objective of developing promising biomarkers via the FDA Biomarker Qualification Program. This feasibility study aims to enroll 25 ASD and 25 TD eligible participants who are 3-5 years old. Read Less

The purpose of the proposed three-site study is to test whether an educator-level implementation strategy, coaching, with or without a school-level implementation strategy, school-based teams, will maximize paraeducators' use (fidelity and sustainment) of an evidence-based social engagement intervention, Remaking Recess (RR). RR aims to improve peer related social skills for autistic students and their non-autistic peers who are socially isolated or peripheral and need support during recess. Read Less

The purpose of the research is to determine whether parent-mediated behavior therapy for challenging behavior commonly displayed by children with autism spectrum disorder (ASD) can be as effective when delivered via telehealth as when delivered in-person. Read Less

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

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

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

The investigators propose to evaluate the use of a telemedicine tool, the TELE-ASD-PEDS (TAP), that is designed to assess for autism spectrum disorder (ASD) symptoms in toddlers. The TAP was developed at VUMC by a team of clinical psychologists with expertise in the early identification of ASD. The TAP has been studied in controlled laboratory settings, with high levels of family and clinician satisfaction, as well as excellent agreement with blinded comprehensive ASD evaluation. The TAP has also been used to complete direct-to-home telemedicine assessments during the COVID-19 pandemic. However, the investigators have not yet compared direct-to-home assessments using the TAP with gold standard, in-person ASD assessments. It has also not yet been studied in a diverse sample of families or with providers outside of VUMC. This study will allow the investigators to address those gaps. Read Less

This study is a 4-year randomized, controlled trial comparing cognitive behavioral therapy (CBT) to usual clinical care for children (aged 6-14 years) with autism and emotional dysregulation (e.g., irritability, anxiety). We will randomly assign 50 mental health clinicians, each treating 2 youth (N = 100 youth total), to CBT program for emotional dysregulation and core autism symptoms with weekly live consultation with an expert or to usual clinical care augmented by self-instruction in CBT, in a 1:1 allocation. The CBT manual is well-supported in our efficacy research, has been replicated in other centers, is free/open-access (meya.ucla.edu), and has user-friendly digital and traditional print materials for mental health clinicians (e.g., psychologists, counselors) to use in preparing for and conducting therapy sessions. The primary outcome measure will be assessed weekly. Additional assessments will occur at Screening, Mid-treatment, Post- treatment and 3-month Follow-up. Read Less