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Autism Spectrum Disorders (ASD)

Autism Spectrum Disorders (ASD), also known as Pervasive Developmental Disorders (PDDs), cause severe and pervasive impairment in thinking, feeling, language, and the ability to relate to others. These disorders are usually first diagnosed in early childhood and range from a severe form, called autistic disorder, through pervasive development disorder not otherwise specified (PDD-NOS), to a much milder form, Asperger syndrome. They also include two rare disorders, Rett syndrome and childhood disintegrative disorder. Learn more about Autism Spectrum Disorders (Pervasive Developmental Disorders).

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For opportunities to participate in NIMH research on the NIH campus, visit the clinical research website. Travel and lodging assistance available.

Featured Studies

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

Translating Evidence-based Interventions for ASD: Multi-Level Implementation Strategy

Study Type: Interventional
Start Date: October 20, 2017
Locations: Sacramento, California; San Diego, California; Westwood, California
Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

The purpose of this study is to test the effectiveness of the "Translating Evidence-based Interventions (EBI) for ASD: Multi-Level Implementation Strategy" (TEAMS) model on provider-level implementation outcomes when used to enhance provider training in two evidence-based interventions for children with autism spectrum disorder (ASD). The TEAMS- Leadership Institute (TLI) module includes training to program/school district leaders in implementation of EBI, and the TEAMS Individualized Provider Strategy for Training (TIPS) module applies Motivational Interviewing strategies to facilitate individual provider behavior change. TEAMS will be tested in combination with two clinical interventions in two community service setting contexts (1) AIM HI intervention in mental health programs and (2) CPRT intervention in schools. It is expected that the addition of TLI and / or TIPS will improve use of EBI by community providers.

Autism Oxytocin Brain Project

Study Type: Interventional
Start Date: May 10, 2017
Location: Atlanta, Georgia
Eligibility: Males, Ages 18–45, Accepts Healthy Volunteers

The main goal of the study is to look at the effects of intranasal oxytocin on the brain in Autism Spectrum Disorder (ASD). Oxytocin is a hormone that exists naturally in the body and the brain. It affects a wide range of social behaviors and emotions. Investigators also seek to study how the effects of oxytocin treatment can be affected by genetic, immune and environmental factors.

Engaging Siblings of Adults With Autism in Future Planning

Study Type: Interventional
Start Date: February 1, 2017
Location: Boston, Massachusetts
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

The proposed project is an intervention development grant in which the investigators will develop a program to facilitate the engagement of adult siblings to work with their families to plan for the future of their brother or sister with autism spectrum disorder (ASD). Siblings FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD) will target common barriers to sibling involvement in family future planning, including improving family communication around difficult topics, increasing siblings' knowledge of and confidence in accessing ASD service systems, and anticipating and proactively problem-solving barriers to future planning. Siblings FORWARD will be implemented in a community setting. There are three aims of the project, and only the third aim will utilize a clinical trial. Aim 1: To develop the Siblings FORWARD program. The investigators will develop the Siblings FORWARD program in collaboration with community organizations, with input from siblings, adults with ASD, and community providers. Aim 2: To assess feasibility of the Siblings FORWARD program. The investigators will assess recruitment capability, appropriateness of outcome measures, acceptability of the program, and viability of the procedures and further refine the Siblings FORWARD Program through an open trial with 5 siblings. Aim 3: To assess the outcomes of participation in the Siblings FORWARD program. The investigators will conduct a pilot randomized controlled trial (RCT) with 36 siblings. The investigators will collect pre-, post-, and 3-month follow up data measuring intervention targets (problem-solving skills, communication skills, self-efficacy, perceived barriers to future planning, knowledge of services & delivery systems, knowledge of family plans), sibling behavioral outcomes (development & implementation of a sibling future plan of action, increased family communication around future planning), and proximal outcomes for the adult with ASD (unmet needs, quality of life, and family relationships). Siblings will be randomly assigned to the Siblings FORWARD (N=18) or an information only control condition (N=18). The investigators hypothesize that siblings who participate in the Siblings FORWARD program will have a more developed plan of action, gains in skills and knowledge, and improved proximal outcomes for the adult with ASD, compared to siblings in the control condition.

A Salivary miRNA Diagnostic Test for Autism

Study Type: Observational
Start Date: November 30, 2015
Location: Syracuse, New York
Eligibility: Ages 2–6, Accepts Healthy Volunteers

The goal of this study is to identify miRNAs that are at increased or decreased levels in the saliva of children with autism spectrum disorder (ASD) or developmental delay and would be useful biomarkers for the screening of toddlers and young children for ASD. These biomarkers may allow earlier diagnosis of autism, allowing earlier service, and also help us to understand some of the changes in the brains of autistic children.

Children's Autism Metabolome Project

Study Type: Observational
Start Date: August 31, 2015
Locations: Scottsdale, Arizona; Little Rock, Arkansas; Sacramento, California; Lexington, Massachusetts; Cincinnati, Ohio; Columbus, Ohio; Philadelphia, Pennsylvania; Nashville, Tennessee
Eligibility: Ages 18 Months and Older, Accepts Healthy Volunteers

Development and Clinical Evaluation of the Stemina Metabolic Biomarker-Based Test to Diagnose Autism Spectrum Disorder in Early Childhood.

An SRT Model for Early Access to ASD Intervention

Study Type: Interventional
Start Date: July 31, 2015
Location: Seattle, Washington
Eligibility: Ages 16 Months and Older, Accepts Healthy Volunteers

This project will implement and evaluate an innovative healthcare service delivery model designed to promote earlier access to specialized intervention for toddlers with ASD. The Screen-Refer-Treat (SRT) model provides a coordinated and cost-effective approach to early identification and intervention by involving both medical and EI providers, and represents a practical and sustainable strategy for bridging the gap between ASD concerns and ASD intervention.

TMS for the Investigation of Brain Plasticity in Autism Spectrum Disorders

Study Type: Observational
Start Date: May 31, 2015
Location: Boston, Massachusetts
Eligibility: Ages 6–65, Accepts Healthy Volunteers

The main purpose is to study brain plasticity (the changes that occur in the brain through experience) in individuals with autism spectrum disorder (ASD). Research suggests that during development, the brains of individuals with ASD may change in response to their experiences differently than the brains of typically developing individuals. Investigators want to understand why and how this difference may contribute to the symptoms of ASD.

Project EARLY: Engagement, Assessment, Referral, & Linkage for Young Children

Study Type: Interventional
Start Date: February 28, 2015
Locations: New Haven, Connecticut; Boston, Massachusetts; Chelsea, Massachusetts; Philadelphia, Pennsylvania
Eligibility: Ages 15 Months and Older, Does Not Accept Healthy Volunteers

Emerging evidence demonstrates that Autism Spectrum Disorder (ASD) can be reliably diagnosed by age two, and that early identification and intervention can improve outcomes. Low-income and minority children with ASD, however, are diagnosed later and experience greater delays in service provision than their white and more financially advantaged peers. Feasible, culturally appropriate interventions with broad scale-up potential are necessary to reduce this disparity. This project builds upon pilot studies of an adapted version of Patient Navigation, as means to reduce disparities in ASD diagnosis and service provision. Patient Navigation is a lay-delivered case management approach that focuses on overcoming logistical hurdles to care during a defined episode.

This project has 2 components, both of which take place in urban, integrated care networks that provide healthcare to low-income children. This registration is for the clinical trial component of the study. The project is a multisite, randomized comparative effectiveness trial of a systemic, lay-delivered adaptation of Patient Navigation, referred to as Family Navigation (FN), which begins with a failed autism screen and ends 100 days after an ASD diagnosis is made. The basic structure of both intervention arms is a collaborative care system. The conventional care management arm (CCM) is consistent with the type of care provided within a traditional - but high quality - medical home. The FN arm provides more intensive, individually tailored, care coordination and theory-based family support.

Changing Developmental Trajectories Through Early Treatment

Study Type: Interventional
Start Date: May 31, 2013
Location: Atlanta, Georgia
Eligibility: Ages 9 Months and Older, Does Not Accept Healthy Volunteers

The major purpose of this study is to directly compare two parent intervention conditions for children diagnosed with autism spectrum disorders at 18 months of age to document the effectiveness.

Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders

Study Type: Observational
Start Date: January 26, 2013
Location: Bethesda, Maryland
Eligibility: Ages N/A–99, Does Not Accept Healthy Volunteers

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.

Examination of Differential Valuation of Leisure Items and Attention as Reinforcers in Children With Autism

Study Type: Interventional
Start Date: June 22, 2012
Location: Atlanta, Georgia
Eligibility: Ages 2–6, Does Not Accept Healthy Volunteers

The purpose of this study is to compare how children with autism, typically developing children, and children with other developmental delays value social attention and toys. The first part of the study seeks to determine whether breakpoints when responding on progressive ratio (PR) schedules can be used to determine the value of leisure items and attention. By comparing the breakpoints obtained for leisure items and attention, the researchers will determine the differential valuation of leisure items and attention. It is anticipated that the manner in which individuals with an autism spectrum disorder (ASD) diagnosis and those who do not will differ with respect to the degree to which they value these two types of stimuli. The second part of the study seeks to determine whether an intervention in which social attention is paired with primary reinforcers impacts responding during the PR assessment, in children with ASD.

Cognitive Neuroscience of Autism Spectrum Disorders

Study Type: Observational
Start Date: November 19, 2009
Location: Bethesda, Maryland
Eligibility: Ages 5–89, Accepts Healthy Volunteers

Background:

- Autism spectrum disorders (ASDs) are a group of developmental disorders that affect communication, social interaction, and behavior. Relatively little is known about the relationship between genetics and behavior among these individuals and their close relatives. Researchers are interested in using interviews and rating scales to better understand these issues, as well as collecting brain scan data and genetic samples for testing and comparison.

- By comparing test results and genetic samples from healthy volunteers, people with ASD, and parents (or caregivers or legal guardians) of the first two groups, researchers hope to better understand the neuroscience of ASD.

Objectives:

- To learn more about the brain in healthy people and in people with autism spectrum disorders.

- To study genes that might be involved in autism spectrum disorders by collecting DNA samples from participants.

Eligibility:

The following groups of participants will be eligible for the study:

- Individuals between 5 and 89 years of age who have autism spectrum disorders.

- Healthy volunteers between 5 and 89 years of age.

- Cognitively impaired children between 5 and 17 years of age.

- Parents/caregivers/legal guardians of individuals in the above three groups.

Design:

- Participants will visit the National Institutes of Health Clinical Center for research tests, which will be administered over multiple visits. Researchers will determine the specific tests to be administered based on the medical history of the study participant.

- Researchers will study the brain through interviews, tests of thinking and memory (neuropsychological tests), brain imaging with magnetic resonance imaging (MRI), and magnetoencephalography (MEG).

- The study will also collect blood or saliva to obtain a DNA sample.

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

Study Type: Observational
Start Date: December 29, 2005
Location: Bethesda, Maryland
Eligibility: Ages N/A–20, Accepts Healthy Volunteers

This study will screen children and adolescents (and their parents) to determine the child's eligibility for participation in NIMH research studies on autism spectrum disorders, such as autism and Rett's Disorder.

Screening evaluations include some or all of the following procedures:

Parent interview

Parent and child evaluations including:

- Diagnostic interview

- Developmental or cognitive testing

- Ratings of psychiatric and medical symptoms

- Neuropsychological testing

- Personal, social an family history

Child physical examination and possible blood draw

Children who are determined eligible for a current NIMH research protocol are invited to participate.