Autism Spectrum Disorders (ASD) Characterization Study

October 21, 2013 updated by: Joseph Biederman, MD, Massachusetts General Hospital

A Characterization Study of Individuals With Autism Spectrum Disorders

The overarching aim of the study is to characterize children and adults with ASDs, and compare them with age-matched controls in relation to their functioning in family, academic, employment, and social spheres. Subjects will be comprehensively assessed in multiple non-overlapping domains of functioning, using psychiatric, cognitive, and psychosocial instruments.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and adults with ASDs.

Controls: healthy volunteers who have never been diagnosed with an Autism Spectrum Disorder.

Description

Inclusion Criteria:

  • Age: 6-60 years old
  • For subjects who have ASD: Meet DSM-IV PDD criteria based on clinical assessment including PDD module of structured interview
  • For subjects who have ASD: One parent/guardian available for interviews about each subject. If a parent or guardian is not available, a reliable adult reporter identified by the subject available for an interview
  • Full-scale IQ of above 80

Exclusion Criteria:

  • Major sensorimotor handicaps (e.g. deafness, blindness)
  • Any severely unstable psychiatric conditions including the following: psychosis, suicidality, bipolar disorder, substance use disorders (alcohol or drugs) that would require in-patient hospitalization.
  • Inadequate command of the English language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ASD
Children and adults with Autism Spectrum Disorders.
Non-ASD
Healthy volunteers who have never been diagnosed with an Autism Spectrum Disorder in their lifetime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall level of functioning of children and adults with autism spectrum disorders (ASD) compared to individuals without ASD.
Time Frame: single time point
single time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (Estimate)

December 3, 2008

Study Record Updates

Last Update Posted (Estimate)

October 22, 2013

Last Update Submitted That Met QC Criteria

October 21, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-P-001951

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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