Skip to main content

Transforming the understanding
and treatment of mental illnesses.

Autism Spectrum Disorder (ASD)

Autism spectrum disorder (ASD) is a developmental disorder that affects communication, behavior, and the ability to function in school, work, or other areas of life. Although ASD can be diagnosed at any age, 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.

nimh_RRStudies_S

Featured Studies

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

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

Study Type: Interventional
Start Date: September 1, 2021
Location: Sacramento, California
Eligibility: Ages 6 Months–99, Does Not Accept Healthy Volunteers

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.

Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder

Study Type: Interventional
Start Date: June 15, 2021
Location: Bethesda, Maryland
Eligibility: Ages 14–25, Accepts Healthy Volunteers

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 6 visits over 6-8 weeks. Healthy volunteers will have 3 visits over 3-4 weeks....

Enhancing Social Competence in Adults With Autism

Study Type: Interventional
Start Date: October 21, 2020
Location: Nashville, Tennessee
Eligibility: Ages 18–35, Does Not Accept Healthy Volunteers

SENSE Theatre®, combines several well-documented, effective behavioral strategies, such as the inclusion of trained peer models, theatre play techniques involving predictable (i.e., scripted) and flexible (improvised) role-play, and repeated performance of newly learned skills resulting in greater automaticity of behavior. The intervention has the potential to enhance social cognition and behavior in adults with autism spectrum disorder.

Social Value Training in Toddlers With Elevated Autism Symptoms

Study Type: Interventional
Start Date: December 13, 2019
Location: New Haven, Connecticut
Eligibility: Ages 15 Months and Older, Does Not Accept Healthy Volunteers

In the proposed pilot study, ASD+ toddlers will undergo Social Value Training (SVT) using a gaze-contingent eye-tracking paradigm in toddlers with elevated symptoms of ASD (ASD+) (n=48). SVT will be administered over a two-day period and the training effects will be assessed by changes in visual attention to high-value (HV) faces as compared to low-value (LV) faces between baseline, post-baseline, and a follow-up assessment using two tasks: a laboratory selective attention (LSA) task and real-world selective attention (RWSA) task. The investigators will also evaluate acceptability and feasibility of the value training and contribution of sex, nonverbal developmental level, and severity of autism symptoms to response to the training.

Iterative Redesign of a Behavioral Skills Training Program for Use in Educational Settings

Study Type: Observational
Start Date: September 1, 2019
Location: Seattle, Washington
Eligibility: Ages N/A and Older, Accepts Healthy Volunteers

This study proposes to redesign the RUBI Parent Training program, a low-intensity intervention for youth with autism spectrum disorder and disruptive behavior, for use by school personnel in the classroom. Using a mixed-methods approach, 40 school staff members from 20 elementary schools will be recruited to inform current classroom behavior management practices and RUBI redesign needs.

Investigation of Brain Plasticity in Autism Spectrum Disorders

Study Type: Observational
Start Date: June 10, 2019
Location: Boston, Massachusetts
Eligibility: Ages 6–18, Accepts Healthy Volunteers

Individuals with autism spectrum disorders (ASD) commonly experience variances in tactile behaviors, such as hypersensitivity to light touch stimuli, altered texture discrimination, and hyporesponsivity to pain. Researchers aim to investigate the somatosensory sensitivity and sensorimotor integration utilizing novel, objective behavioral assays and TMS. The main purpose is to study brain plasticity (the changes that occur in the brain through experience) in individuals with autism spectrum disorders.

Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism

Study Type: Interventional
Start Date: March 4, 2019
Location: Nashville, Tennessee
Eligibility: Ages 15 Months–3, Does Not Accept Healthy Volunteers

In this study, the investigators are trying to find new ways to screen for autism spectrum disorder (ASD) in young children. The investigators want to see if people like pediatricians can screen children for ASD while a psychologist watches on a monitor. The investigators are testing two screening tools. The investigators want to see if they are good at identifying children with ASD and children without ASD. The investigators hope this research will make it easier for families to get answers when there are concerns for ASD.

VR Intervention to Improve Police Safety

Study Type: Interventional
Start Date: November 28, 2017
Location: Philadelphia, Pennsylvania
Eligibility: Ages 12–60, Does Not Accept Healthy Volunteers

The primary objective of this study is to demonstrate the efficacy of Floreo's police safety module (PSM) in adolescents and adults with autism spectrum disorder (ASD) by assessing improvement in police interaction skills as compared to a video modeling intervention.

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.

Study of Neuroimaging Biomarkers of Social Cognition Deficits in Adolescents (Age 13-17) With Autism Spectrum Disorder and Effects of Gabapentin

Study Type: Interventional
Start Date: September 14, 2017
Location: Worcester, Massachusetts
Eligibility: Ages 13–17, Does Not Accept Healthy Volunteers

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder that is increasing in prevalence, and is characterized by deficits in social communication and interaction across multiple contexts, and restricted, repetitive patterns of behavior, interests, or activities. The majority of individuals with ASD have poor outcomes in the area of social functioning; however, there are no medical treatments available that target the core social communication deficits. The goal of the proposed research is to understand the neurobiological role of an imbalance in excitatory (glutamate) and inhibitory (gamma-aminobutyric acid, GABA) neurotransmission in the social cognition deficits in ASD, and to develop proton magnetic resonance spectroscopy as a measurement of target engagement to measure the ability of a medication, gabapentin, to increase cortical GABA levels. Spectrally-edited proton magnetic resonance spectroscopy (1H-MRS) provides an ideal method for measuring cortical GABA levels. All proposed studies will be in 70 adolescents (male and female) with ASD (age 13 to 17 years). Specific Aim 1: To measure correlations of 1H-MRS GABA levels in the anterior cingulate cortex (ACC) and occipital cortex (OC) with clinical measures of social cognition at baseline. Specific Aim 2: To measure the effect of an initial one time dose of gabapentin on 1H-MRS GABA levels in the ACC and OC. The hypotheses are 1) that higher social cognition ability will be positively correlated with GABA in the ACC but not in the OC (a control, non-social cognition-related region) of individuals with ASD, and 2) that gabapentin will increase GABA levels in the ACC and OC of youth with ASD.

Feasibility of Implementing a Mental Health Care Program and Home-based Training for Mothers of Children With Autism Spectrum Disorder in an Urban Population in Bangladesh

Study Type: Interventional
Start Date: April 1, 2017
Location: Dhaka, Bangladesh
Eligibility: Females, Ages 18–50, Does Not Accept Healthy Volunteers

Background (brief):

The global burden of depression accounts for 2.5% of global DALYs, and in South Asia the estimate is 13.3 % of DALYs per 100,000 populations. Mothers of children with Autism Spectrum Disorder (ASD) have reported higher level of depression than mothers of children with other developmental disorder and the prevalence of ASD is high in Asian countries. In Bangladesh 16% of adults suffer from depression and a recent study conducted in Bangladesh has documented a high prevalence of depression among mothers of children with ASD (45%). Mothers are the life time care givers of children with ASD, and a high burden of depression is likely negatively impact on the ability of the mothers to provide care to children at home. Mental health is not addressed in Bangladesh and there is scarcity of qualified providers.

Objectives:

The investigators propose to pilot the feasibility of a package intervention including implementation of mental health care and home based training program for the mothers of children with ASD integrated in the regular activities of the special schools that offer ASD care in Dhaka city in Bangladesh.

Methods:

The study will be conducted in 2 selected special schools over 15 months. In the first stage, the investigators will set up the study in two schools and identify various stakeholders for qualitative assessment of the barriers of implementing the intervention at the institutional level, individual level, family level, provider level, policy maker level and at the level of the state. Research staff will identify mothers 18 years of age or older who has a child with ASD between 3 and 17 years of age enrolled in the school. Following consent, data collector will obtain data and assess current major depressive episode (MDE) of the eligible mothers following a standard diagnostic tool (SCID-I). All mothers diagnosed as having MDE will be invited to participate in the intervention (intervention mothers) and the investigators will assess the performances in children with ASD by applying ASD Diagnostic Check-list (ADCL).

In the second stage, investigators will implement interventions over 4-6 months, including (a) implementing mental health care services at the selected schools targeting the intervention mothers, and (b) organizing training sessions of the intervention mothers for supporting child care at home for enhancing child performances. Every month a psychiatrist will visit each school for providing necessary advice and treatment to the intervention mothers or suggest referral to hospital care, if necessary.

One special educator will be deployed at each school who will organize structured training sessions for educating the intervention mothers by using BCC materials developed and validated by icddr,b in the local setting. The special educators will conduct multiple group sessions including 5-8 mothers in each group for covering the 6 modules over 2 weeks time, and follow up intervention mothers at home every month for conducting refresher's training, documenting the need of additional training supports, and linking mother with an ASD expert for helping mothers taking a decision.

In stage 3, investigators will conduct post intervention qualitative survey with various stakeholders who would be involved with implementing the intervention and participated in the baseline qualitative survey. End line assessment will be conducted of current major depressive episode (MDE) among all mothers and assess the performance of the children of intervention mothers in order to assess the impact of the training at home.

Outcome measures/variables:

The primary outcome of the study is to assess the feasibility of institutionalizing the combined intervention of mental health care supports and the home based training program of the mothers who would be diagnosed as having major current major depressive episode. The primary outcome will be assessed by obtaining the perspectives of various stakeholders. The following parameters will be assessed for measuring feasibility of the proposed intervention.

Acceptability, Adaptability, Demands, Practicality, Implementation, Integration

The secondary outcomes will include estimating the impact of the combined interventions on the prevalence rate of maternal depression (MDE), individual performances of children, and cost of intervention. Adaptation of the proposed strategy, if feasible will help the mothers of children with ASD become skilled workforces for filling in the gap of the special educators in resource poor settings, and extension of these services to more children with ASD.

A Salivary miRNA Diagnostic Test for Autism

Study Type: Observational
Start Date: November 1, 2015
Location: Syracuse, New York
Eligibility: Ages 24 Months and Older, Accepts Healthy Volunteers

The goal of this study is to validate a panel of miRNAs that distinguish children with autism spectrum disorder (ASD) from their non-ASD peers with a positive MCHAT-R. 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.

Detection of ASD at the 1st Birthday as Standard of Care: The Get SET Early Model

Study Type: Observational
Start Date: August 31, 2014
Locations: Phoenix, Arizona; La Jolla, California
Eligibility: Ages 12 Months and Older, Accepts Healthy Volunteers

According to a recent report from the Centers for Disease Control, most children with ASD do not receive a diagnosis and begin receiving treatment until well after their 4th birthday, which is unfortunate given that many connections between brain cells have already been established by that age. This program will test a model called Get S.E.T. Early (S=Screen, E=Evaluate, T=Treat) in both San Diego and Phoenix, designed to detect, evaluate, and treat ASD within the first 2 years of life. In this proposal 7,500 toddlers from the general population will be screened in San Diego and Phoenix (total 15,000) using the CSBS IT Checklist (Wetherby & Prizant, 2002) at well baby check-ups using a "triple screen" approach wherein toddlers are screened at three ages starting at 12 months. Investigators predict that providing screening tools with clear cut-off scores and guidelines for automatic referral for both evaluation and treatment will result in dramatically lowering mean age of detection in Phoenix from 4-5 years down to 1-2 years. Investigators also predict that using repeat screening at 12, 18, & 24 months in combination with automatic referral options via technology (i-Pads) will result in an increase in the number of ASD toddlers detected by 24 months relative to a single time point screen using traditional paper screens.

Sensory and Connectivity Abnormalities in Autism Spectrum Disorders

Study Type: Observational
Start Date: June 30, 2013
Location: Charlestown, Massachusetts
Eligibility: Ages 14–32, Accepts Healthy Volunteers

Study the neural substrates of autism spectrum disorders using neuroimaging methods such as MEG/EEG/MRI.

Participant Database for Autism Research Studies

Study Type: Observational
Start Date: June 30, 2013
Location: Charlestown, Massachusetts
Eligibility: Ages 14–32, Accepts Healthy Volunteers

The purpose of this study is to create a subject database to recruit for current and future studies in research on autism and other neurodevelopmental disabilities.

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: December 27, 2012
Location: Bethesda, Maryland
Eligibility: Ages N/A–99, Accepts 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.

Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome)

Study Type: Interventional
Start Date: February 29, 2012
Location: New York, New York
Eligibility: Ages 5–12, Does Not Accept Healthy Volunteers

The purpose of this study is to pilot the use of Insulin-Like Growth Factor-1 (IGF-1) treatment in 22q13 Deletion Syndrome (Phelan-McDermid Syndrome) caused by SHANK3 gene deficiency in order to evaluate safety, tolerability, and efficacy. IGF-1 is an injection under the skin that contains human IGF-1. IGF-1 is approved by the FDA under the brand name Increlex for the treatment of children with short stature due to primary IGF-1 deficiency. It is being used off-label in the current study and is not FDA approved, nor has it yet been studied in humans for the treatment of SHANK3 deficiency.

Cognitive Neuroscience of Autism Spectrum Disorders

Study Type: Observational
Start Date: February 21, 2010
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.