# Autism Spectrum Disorder (ASD)

Autism spectrum disorder (ASD) is a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave. Although autism can be diagnosed at any age, it is described as a “developmental disorder” because symptoms generally appear in the first two years of life. ASD is known as a “spectrum” disorder because there is wide variation in the type and severity of symptoms people experience. Learn more about autism spectrum disorder.

## Featured Studies

Featured studies include only those **currently recruiting participants**. Studies with the most recent start date appear first.

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### Modulating Temporoparietal Junction Mentalizing-Related Activity in Autism Spectrum Disorder (ASD) Using Transcranial Magnetic Stimulation (TMS) **

**Study Type:** Interventional**Start Date:** April 3, 2024**Eligibility:** 18 Years to 35 Years, Accepts Healthy Volunteers**Location(s):** Olin Neuropsychiatry Research Center (ONRC), Hartford, Connecticut, United States    

The goal of this observational study is to test the modulation effect of different transcranial magnetic stimulation (TMS) on the neural network supporting our ability to create mental representations of others (also known as mentalizing) in young adults with autism. The main question it aims to answers is can stimulation of the right temporoparietal junction can change brain activity related to mentalizing during social interaction in the stimulation area and other brain areas connected to it. Researchers will compare results to a group of individuals without autism to see if the patterns of neural activity change are similar between the groups.

Participants will undergo assessment of their clinical traits and social skills and baseline MRI scan. They will attend three additional visits that include TMS session and functional MRI scans before and right after TMS.

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### Examining the Effectiveness of the Early Start Denver Model in Community Programs Serving Young Autism **

**Study Type:** Interventional**Start Date:** March 1, 2024**Eligibility:** 12 Months and Older, Does Not Accept Healthy Volunteers**Location(s):** University of California, Davis MIND Institute, Sacramento, California, United States    

This study tests the effectiveness of the Early Start Denver Model (ESDM) in community agencies that serve young autistic children. The feasibility, usability and acceptability of the model will be explored. Understanding effectiveness of new evidence-based models will increase the quality of autism care available to more diverse children and families in more geographic locations.

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### An Online Evaluation of Work Chat **

**Study Type:** Interventional**Start Date:** July 7, 2023**Eligibility:** 18 Years and Older, Accepts Healthy Volunteers**Location(s):** University of Michigan, Ann Arbor, Michigan, United States    

This study is aiming to see if it is feasible for the intervention Work Chat to be delivered in a completely online setting to adults with autism spectrum disorder.

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### Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers **

**Study Type:** Interventional**Start Date:** July 3, 2023**Eligibility:** 18 Months to 36 Months, Does Not Accept Healthy Volunteers**Location(s):** Vanderbilt University Medical Center, Nashville, Tennessee, United States    

The primary goal of this study is to examine rhythm sensitivity as a predictor of response to naturalistic developmental behavioral intervention (NDBIs) in autistic toddlers. Toddlers receive either Reciprocal Imitation Training (RIT), an evidence-based NDBI that supports children's imitation and social communication skills, or a music-enhanced version of RIT. Throughout their participation in the intervention, toddlers will complete study procedures of viewing naturalistic videos of infant-directed singing and other social scenes while eye gaze data is collected.

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### Effectiveness Trial of Mobile ESI for Toddlers With Autism Identified by Early Screening in Primary Care **

**Study Type:** Interventional**Start Date:** March 15, 2023**Eligibility:** 15 Months to 20 Months, Accepts Healthy Volunteers**Location(s):** Florida State University Autism Institute, Tallahassee, Florida, United States    

The goal of this collaborative R01 is to demonstrate the therapeutic value and community-wide implementability of an early intervention (EI) platform for toddlers with autism spectrum disorder (ASD) that is completely virtual, from recruitment through intervention. This platform-Early Social Interaction Mobile Coaching (ESI-MC) deploys individual telehealth sessions with coaching and feedback to help families embed intervention in everyday activities. Specifically, the investigators will conduct an effectiveness trial of ESI-MC to address the important question of whether starting evidence-based intervention earlier leads to better outcomes than starting later. The investigators will address this question by using a modified stepped wedge design and blended implementation research to analyze data obtained with ESI-MC start at 18, 24, or 30 months. The investigators will diagnostically ascertain 240 children from a pool of 360 18-month-olds with early signs of autism, 30 in each of 8 US regions (Central and SW Florida; Atlanta, GA; suburbs of Philadelphia, PA; New York City, NY; Cincinnati, OH; Chicago, IL; Seattle, WA; and Los Angeles, CA). Research participants will be recruited using a new virtual platform-My Baby Navigator-linking a new surveillance and screening tool, an app to upload video-recorded home observations and telehealth intervention sessions, and a package of educational resources. The 240 children will be randomly assigned to one of three ESI-MC timing groups. ESI-MC will be delivered by community-based early intervention providers (EIPs) currently working within the the early intervention system in the recruitment regions. The investigators will measure child active engagement and social communication change every 6 months as the primary outcome variables. Outcome measures of developmental level, autism symptoms, and adaptive behavior will be examined to measure differential treatment effects. Maximizing the use of mobile technology, ESI-MC offers the prospect of a community-viable, scalable and sustainable treatment to improve EI services for toddlers with ASD, particularly among minority and low-resource communities.

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### The Effectiveness of an Autistic-delivered Peer-support Intervention for Autistic Adults: Community Autism Peer Specialist (CAPS) Program **

**Study Type:** Interventional**Start Date:** February 9, 2023**Eligibility:** 18 Years to 30 Years, Accepts Healthy Volunteers**Location(s):** Drexel University, Philadelphia, Pennsylvania, United States    

The number of autistic adults reached 5.4 million in the United States in 2017 and is projected to continue to rise, but evidence-based practices to optimize their health and well-being are limited and poor outcomes are common. This study will leverage existing infrastructure to finalize the development of a novel support service provided by peers with lived experience, incorporating input from autistic peer specialists, autism researchers, peer support researchers, and experts in peer support training. Investigators will then conduct a pilot randomized controlled trial to examine the effectiveness of the service while also examining the feasibility, acceptability, and implementation procedures in preparation for future large-scale testing and dissemination.

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### Screening for Autism in 9-Month-Olds by Measuring Social Visual Engagement **

**Study Type:** Observational**Start Date:** February 2, 2023**Eligibility:** 8 Months to 10 Months, Accepts Healthy Volunteers**Location(s):** Emory Univeristy, Atlanta, Georgia, United States; Children's Healthcare of Altanta, Atlanta, Georgia, United States    

The goal of this project is to measure the clinical utility of an objective and quantitative eye-tracking assay collected on a standalone, mobile investigational device to accurately screen 9-month-old infants for autism spectrum disorder and other actionable delays.

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### HEARTS R34 Feasibility Study, Autistic Participants **

**Study Type:** Interventional**Start Date:** February 1, 2023**Eligibility:** 18 Years and Older, Does Not Accept Healthy Volunteers**Location(s):** Boston University CRC, Boston, Massachusetts, United States    

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.

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### Can a Novel Telemedicine Tool Reduce Disparities Related to the Identification of Preschool Children With Autism? **

**Study Type:** Interventional**Start Date:** June 1, 2022**Eligibility:** 36 Months to 72 Months, Accepts Healthy Volunteers**Location(s):** Vanderbilt University Medical Center, Nashville, Tennessee, United States    

Families seeking evaluation for autism spectrum disorder (ASD) often face barriers such as low availability of specialists, lengthy waitlists, and long distances to tertiary care diagnostic centers. This is especially true for children from traditionally underserved groups and communities. Without innovative approaches for enhanced identification of ASD, families and clinicians will continue to struggle with accessing and providing care. Telemedicine offers tremendous potential for addressing this need, but there are few psychometrically sound, validated tools that can be administered remotely, via telehealth platforms. This team of investigators developed and conducted a preliminary evaluation of a novel parent-administered, clinician-guided tele-diagnostic tool, the TAP (TELE-ASD-PEDS), designed specifically for direct-to-home and community clinic use with toddlers. Remote administration of the TAP yielded a very high level of agreement with blinded comprehensive evaluation regarding ASD risk classification. Subsequently, the unanticipated broad dissemination of the TAP during COVID-19 demonstrated its value for traditionally underserved groups, spanning broad geographies. Although promising, this work was limited by its specific focus on toddlers with ASD concerns. A telemedicine tool designed for the unique context and population of preschool-aged children referred for diagnostic assessment could have tremendous value in terms of both accurate identification as well as family engagement with service. In the current work, the investigators will now evaluate the performance, usability, and utility of the TAP-Preschool, a new telemedicine tool for ASD risk assessment in preschoolers, through a clinical trial. The TAP-Preschool was developed through a computationally informed co-production in which the targeted population were recruited as active partners in designing the tool. The investigators will gather critical data not only regarding its structure and accuracy, but also its potential deployment across systems responsible for engaging children and families from underserved groups in meaningful service. This work has potential to transform the ASD evaluation process and dramatically improve care access for traditionally underserved groups.

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### The Autism Biomarkers Consortium for Clinical Trials: Confirmation Study **

**Study Type:** Observational [Patient Registry]**Start Date:** April 11, 2022**Eligibility:** 6 Years to 11 Years**Location(s):** Children's Hospital Los Angeles, Los Angeles, California, United States; Duke, Durham, North Carolina, United States; Boston Children's Hospital, Boston, Massachusetts, United States; Yale Child Study Center, New Haven, Connecticut, United States; Unviersity of Washington, Seattle, Washington, United States    

This is a multicenter longitudinal study that aims to validate a set of measures that were previously identified as promising candidate biomarkers and/or sensitive and reliable objective measures of social function in ASD for potential use in clinical trials. The confirmation study will repeat the data collection and analysis protocols from the original ABC-CT study. This confirmation study will recruit 200 ASD and 200 TD comparison participants who are 6-11 years old, matching the overall sample size but providing a larger normative reference sample and greater statistical power for group comparisons.

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### Cerebellum and Autism: Regional Specialization for Social and Executive Functions **

**Study Type:** Interventional**Start Date:** January 1, 2022**Eligibility:** 18 Years to 35 Years, Accepts Healthy Volunteers**Location(s):** American University, Washington, District of Columbia, United States    

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.

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### Addressing Disparities in Autism Spectrum Disorder Diagnosis Using a Direct-to-home Telemedicine Tool **

**Study Type:** Interventional**Start Date:** December 3, 2021**Eligibility:** 18 Months to 42 Months, Does Not Accept Healthy Volunteers**Location(s):** UC Davis MIND Institute, Sacramento, California, United States    

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.

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### Improving the Part C Early Intervention Service Delivery System for Children With ASD **

**Study Type:** Interventional**Start Date:** September 27, 2021**Eligibility:** 16 Months to 30 Months, Does Not Accept Healthy Volunteers**Location(s):** Rush University Medical Center, Chicago, Illinois, United States; University of Massachusetts Boston, Boston, Massachusetts, United States; Michigan State University, East Lansing, Michigan, United States; Carol A Schubert, Seattle, Washington, United States    

Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to increase timely and equitable access to ASD-specialized early intervention during the critical first three years of life by capitalizing on the existing infrastructure of the Part C Early Intervention (EI) system, which is publicly funded and available in all U.S. States. This project will train EI providers to use an evidence-based, inexpensive, parent-mediated intervention that can improve child and family outcomes as well as mitigate the long-term substantial economic costs associated with ASD.

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### Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder **

**Study Type:** Interventional**Start Date:** June 15, 2021**Eligibility:** 14 Years to 25 Years, Accepts Healthy Volunteers**Location(s):** National Institutes of Health Clinical Center, Bethesda, Maryland, United States    

Background:

Autism spectrum disorder (ASD) is a complex neurodevelopmental syndrome. Researchers think brain development may be controlled by gamma-aminobutyric acid (GABA). They want to learn how abnormalities in the GABA system may contribute to ASD.

Objective:

To see if repetitive transcranial magnetic stimulation (rTMS) creates short-term changes in how different parts of the brain communicate.

Eligibility:

Right-handed people ages 14-17 with ASD, and healthy volunteers ages 18-25.

Design:

Participants will be screened with:

Medical history

Physical exam

Medicine review

Neurological exam

Psychological tests and rating scales

Forms and surveys.

Participants will have a hearing test and ear exam.

Participants will have magnetic resonance imaging (MRI) of the brain. They will lie on a table that moves in and out of the MRI scanner. They may look at a screen while in the scanner. A coil will be placed over their head.

Participants will have magnetic resonance spectroscopy. It takes pictures of chemicals in the brain using the MRI scanner.

Participants will have magnetoencephalography. They will sit in a chair. A helmet with magnetic field sensors will be placed on their head.

Participants will have TMS. A wire coil will be held on their scalp. A brief electrical current will pass through the coil.

Participants will have electromyography. Sticky pad electrodes will be placed on the skin during TMS. The electrical activity of their muscles will be measured.

Participants will have rTMS. It uses short bursts of magnetic pulses to affect brain activity.

ASD participants will have 7 visits over 2-3 months. Healthy volunteers will have 3 visits over 3-4 weeks....

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### Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders **

**Study Type:** Observational**Start Date:** December 27, 2012**Eligibility:** 99 Years and Younger, Accepts Healthy Volunteers**Location(s):** National Institutes of Health Clinical Center, Bethesda, Maryland, United States    

Background:

- Many psychiatric, behavioral, and developmental disorders are genetic. This means that they tend to run in families. Some begin in childhood, while others do not appear until adulthood. Researchers want to look at people of all ages who have these disorders that started in childhood. They will also look at relatives of people with these disorders. This information will allow doctors to learn more about childhood behavioral problems and how they are inherited. It may also help doctors treat those disorders.

Objectives:

- To study the onset and treatment of childhood behavioral, psychiatric, and developmental disorders.

Eligibility:

Individuals of any age who have a psychiatric, autism spectrum, or developmental disorder, or other behavioral problems. Family members of individuals with the above disorders. This group may include parents, grandparents, siblings, aunts/uncles, cousins, and children.

Design:

Participants will be screened with a medical history and physical exam. They will have a psychiatric history with tests of thinking, judgment, and behavior. Blood and urine samples will be collected. Brain imaging scans will be performed to look at brain function. They may have a spinal tap to collect cerebrospinal fluid. Relatives will have a medical history and physical exam. They will also have a psychiatric history with tests of thinking, judgment, and behavior. Blood and urine samples will be collected. Brain imaging scans will be performed to look at brain function. A relative s exams may reveal a behavioral or other disorder. If so, he or she may re-enroll on the study as a person with the disorder.

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### The Neurodevelopmental and Behavioral Phenotyping Screening Protocol **

**Study Type:** Observational**Start Date:** February 27, 2006**Eligibility:** 6 Weeks and Older, Accepts Healthy Volunteers**Location(s):** National Institutes of Health Clinical Center, Bethesda, Maryland, United States    

The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.