300,000+ clinical trials. Find the right one.

281 active trials for Autism Spectrum Disorder

Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder

The main objective of the current proposal is to conduct a pilot RCT (i.e., treatment group and social skills control group) to examine how participation in Surviving and Thriving in the Real World (STRW) Intervention affects proximal outcomes with a larger sample size (n = 72). As social skills, executive functioning, and parenting factors have been linked to the acquisition of Daily Living Skills (DLS), the current study will also explore how these are linked to participation in STRW. Lastly, goal attainment scaling (GAS) will be utilized, along with gold standard parent report and adolescent self-report measures, to assess DLS.

Start: May 2018

Piloting an Enhanced Protocol of Occupational Therapy in an Equine Environment for Youth With Autism

The purpose of this study is to learn about occupational therapy for youth with autism in a traditional clinic environment, and in an equine environment. 20 youth with autism will participate in 10 weeks of occupational therapy in a clinic environment, followed by 10 weeks of occupational therapy in an equine environment. Caregivers will complete online surveys about their child's behavior. Occupational therapists and other stakeholders will provide feedback about the interventions. The therapy sessions that involve horses will be videotaped, and a researcher will look at the behaviors of the horses involved in the intervention. We will use the results of this study to improve the quality of both interventions.

Start: January 2020

Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders

The investigators will recruit 30 children and adolescents (15 per group x 2 groups) aged 6 to 17 years with ASD and significant repetitive behaviors that cause problems to them and to others around them. Subjects will be randomized to either amitriptyline (AMI), dosed flexibly according to response and tolerability with a maximum dose of 100mg per day or 1.5mg/kg/day, in divided doses to minimize side effects, or placebo in look-alike capsules, for 12 weeks. Rating scales, and eye-tracking will be used to measure outcomes.

Start: June 2021

Evaluating the Impact of Telehealth-Based ASD Assessments and Supports on Child and Caregiver Outcomes

The overall goal of this study is to evaluate telehealth and internet-based approaches to meet accessibility challenges for families with concerns about ASD in their infants. In this study, we will gather exploratory data related to the potential of two telehealth tools: 1) The Telehealth Evaluation of Development for Infants (TEDI); and 2) "Help is in Your Hands" (HIIYH), a set of video materials and information on interactive strategies parents can use to support their child's communication development. We will recruit families participating in an ongoing study using the TEDI (R21 HD100372, PI: Talbott) to evaluate infants' behavioral development. As families exit the parent TEDI study and enter the current study, we will ask parents to complete online questionnaires, and randomize them to either receive immediate access to additional online materials (HIIYH) for parents or no additional materials. After 12 weeks, parents will complete online questionnaires and all families will then be given access to the online materials. When children reach 30 months, we will collect additional questionnaires, complete a live telehealth behavioral session with toddlers and their caregivers, and conduct an exit interview with parents to gather feedback about their experience.

Start: June 2021

Trial of Autism Parent Navigator Program

To address the dual needs of parents for support in navigating Autistic Spectrum Disorder (ASD) services and maintaining positive family functioning, the investigators propose to test Autism Parent Navigators (APN), an innovative in-home, peer support model for parents with a young child recently diagnosed with ASD.

Start: March 2021

Treatment of Sleep Disturbance in Children With ASD

This RCT study aims to compare effectiveness physical exercise and melatonin supplement on treating sleep disturbance in children with ASD. A four-arm randomized controlled trial with equal allocation ratio to the three intervention groups (i.e., jogging; melatonin supplement, combine jogging and melatonin supplement) and one placebo-control group will be conducted . Actigraph device and sleep log will be used for sleep assessment. 6-sulfoxymelatonin from 24-h and first morning urinary samples. The investigators will monitor the changes of four sleep parameters (sleep onset latency, sleep efficiency, wake after sleep onset and total sleep duration) and the 24-h and first morning melatonin level throughout the whole study.

Start: September 2021

Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder

The main purpose of this study is to evaluate safety and tolerability, Pharmacokinetics and Pharmacodynamics, as well as exploratory efficacy of STP1, in a subgroup of patients with Autism Spectrum Disorder (ASD).

Start: December 2020

Care Improving Cognition for ADolescents on the Autism Spectrum

This is a validation study to evaluate the acceptability, feasibility and impact of CICADAS (Care Improving Cognition for ADolescents on the Autism Spectrum), a clinician-assisted, mobile application that aims to prime the brain to engage in flexible, adaptive long-term learning about social-emotional events through closed-loop technology.

Start: June 2021

Intermittent Theta-Burst Stimulation to Target Irritability in Adults With ASD

This study aims to demonstrate the feasibility, tolerability, safety and preliminary efficacy of 6 weeks of fMRI-guided iTBS delivered to personalized regions of the prefrontal cortex (PFC) in adults with ASD in reducing irritability in adults with ASD.

Start: May 2022

Robotic Intervention Framework for Children With Autism Spectrum Disorder to Enhance Social Engagement and Participation

This study will develop and test a Robotic Intervention Framework for Children with ASD in the real context. The first part of this study will focus on the identification and initial testing of core elements of effective robotic intervention programs to form a practice framework. Pat II will use a randomized control trial to test the efficacy of the robotic intervention programs that incorporated all elements of the framework. Part III will use a qualitative approach to examine the qualitative outcomes of the program with reference to the elements of the practice framework. With a framework that is built upon evidence and tested sufficiently, practice guidelines and intervention protocol will be delineated to ensure success of robotic intervention programs.

Start: May 2021

Achieving Steady Work Among Adults With Autism Through Specialized Employment Program

Individuals with autism spectrum disorder (ASD) have significantly higher levels of unemployment and underemployment compared to their typically developing peers and all other groups with neurodevelopmental disorders, even though major companies that have employed and trained young people with ASD acclaim their significant innovations in their companies. The investigators hope to examine the effects of specialized employment support programs, over current traditional vocational rehabilitation approaches, for adults with ASD on their ability to maintain steady employment and overall benefit to the organizations at which they will be employed. The investigators predict that Stanford University's Neurodiversity at Work (NaW) Program will improve employment outcomes and positively impact the overall quality of life of individuals with ASD in this program. The investigators hope that the findings of the study will lead to the advancement of programs aimed to support individuals with ASD.

Start: September 2019

A Multi-dimensional Prospective Study to Discover Gene-microenvironment Interactions in Neurodevelopmental Disorders

This project is the first involving the two most common neurodevelopmental disorders, ASD and ADHD, as well as TDC to establish a multi-dimensional database (clinic, behavior, neurocognitive function, brain imaging, metabolomics, and microbiome) using the same methodology. Based on this integrated multi-dimensional databank, we anticipate exploring metabolic flows of the gut-brain axis during brain development and identifying the common and unique biomarkers of ASD and ADHD and high-risk materials related to their functions and the underlying mechanism. Moreover, distinguishing the characteristics of the gut microbiota, gastrointestinal disorders, and microbial flora dysbiosis also helps us, in turn, to accelerate the process of identifying biological treatments that can interfere or slow down the severity of cognitive impairments in neurodevelopmental disorders. Eventually, we anticipate finding the clinical and neurocognitive measures related to the direct or indirect influence of gut-brain signaling. Our findings are anticipated to improve the knowledge about neurodevelopmental disorders, enhance developing early detection, diagnosis, and treatment for ASD and ADHD, and contribute to precision medicine.

Start: January 2021

Precise Objective Automated Assessment System of Autism Spectrum Disorder From an Existing Big Cohort

The project's significance includes a big cohort of Autism spectrum disorder (ASD), originality/novelty (new approaches and technologies including next-generation sequencing, multi-echo functional MRI, metabolomics, microbiomics, and machine learning), and the integration of multi-dimentional measures. With the accomplishment of this project, we will establish the most comprehensive ASD bio-bank in Asia, develop ASD NGS panel, identify several ASD biomarkers, publish at least 15 SCI papers in total, and in the end, have patents registration and technology transfer of our precise objective, automated assessment system for ASD. Our findings will further advance our understanding of ASD, ultimately contribute to the early detection, diagnosis, and treatment of ASD, and be the first step of precise medicine for ASD.

Start: August 2018

Vitamin/Mineral Supplement for Children With Autism

This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism.

Start: May 2021

Stepped-Care Cognitive-Behavioral Treatment for Youth With ASD and Anxiety

This study implements a parent-led, flexible, individually-tailored cognitive-behavioral intervention for children with ASD and anxiety.

Start: February 2019

Modifying (Phase I) and Evaluating (Phase II) Virtual Reality Job Interview Training for Youth in Transition

The unemployment rate is quite high among adults with an autism spectrum disorder (ASD). Inadequate transition planning during high school and gaps between vocational needs and availability of evidence-based services help explain the struggles of transition-age youth at obtaining employment. There is a paucity of research on developing and evaluating services to support the transition to the work force after graduating from high school. The lack of available resources to support transition-age youth with an ASD speaks to the need to develop interventions that ameliorate obstacles to employment and help support the transition to the work force. Due to the social deficits characterizing ASD innovative interventions could target preparing job interview skills for students facing the transition to employment as the job interview is a critical gateway to securing a job offer. Thus, the overarching goal of this study is to modify an existing virtual reality job interview skills training program for use in high school students with ASD and to test the feasibility and effectiveness of conducting this intervention in a high school setting via a small controlled trial. Thus, study's first aim is to modify the existing 'Virtual Reality Job Interview Training' program to meet the specific needs of high school seniors with ASD. This will accomplish this by conducting in depth interviews with high school students with ASD and their vocational counselors to solicit feedback to modify the current training's learning goals, content, usability, and simulated interview scripts to meet the specific needs of transition age youth. An expert panel will determine the final modifications to the training program based on the results of the qualitative data analysis and their own views of the program. Second aim of the study is to conduct a pilot trial to evaluate the feasibility, acceptability, portability, fidelity and preliminary effectiveness of the modified intervention in a randomized controlled trial. This study will also explore potential mechanisms for effectiveness and collect pilot implementation data.

Start: October 2018

Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD

This study implements an anxiety-focused, parent-led, therapist-assisted cognitive behavioral teletherapy for parents of youth with ASD and anxiety.

Start: July 2019

A Deep Learning Algorithm Platform to Predict Autism Diagnosis and Subtypes

This is the first human study on ASD microbiome with robust methodologies: prospective and sibling designs, metagenomics profiles, establishing an ASD multi-dimensional databank (clinic, behavior, neurocognition, brain imaging, metabolomics, and microbiome) collected using the same methodology and genetic biology simultaneously, and developing a deep learning platform for ASD diagnosis and prevention. With the accomplishment of this project, we anticipate establishing a web application for clinical and academic use. Our findings will further advance the knowledge in the pathogenetic mechanisms of ASD to enhance early detection, diagnosis, and treatment, subsequently contributing to precision medicine.

Start: May 2020

Study of the Genetic Factors Involved in Autism and Related Disorders

The main objective of the study is to define, for Autism Spectrum Disorder, the extent of genetic variation in synaptic pathways that may be targeted for therapeutic development. For this purpose the investigators will take advantage of large, well-characterized cohorts of patients with Autism Spectrum Disorder for genetic screenings. Targeted sequencing of selected synaptic genes, previously associated with Autism Spectrum Disorder, will be carried out in these cohorts with deep coverage of coding regions and a strong focus on previously untested regulatory regions. Genomic data from Copy Number Variant, whole genome sequencing and exome sequencing, available for some of these patients, will be integrated in the overall analysis. The investigators will strongly emphasize the establishment of comprehensive genotype/phenotype correlations.

Start: March 2021

Improving Transition Outcomes for Youth With ASD in a Medicaid Accountable Care Organization

Despite an increasing number of children with Autism Spectrum Disorder (ASD), fragmentation across child and adult service systems results in poor education, employment and health outcomes for transition-aged youth (TAY). The investigators will develop a transition intervention embedded in a series of systems-level strategies currently being deployed in a large Medicaid Accountable Care Organization (ACO). The investigators will conduct a randomized pilot study of 40 families of TAY with ASD. All families will receive care by providers trained in the Got Transition toolkit (the systems level component of the intervention) and have access to web-based transition resources. Families in the 'intervention refinement' arm will also receive a family-based problem solving education (PSE) intervention.

Start: August 2021