Autism Spectrum Disorders (ASD) Characterization Study

This study has been completed.

Sponsor:

Information provided by:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00801554

First received: December 2, 2008

Last updated: April 12, 2011

Last verified: April 2011

History of Changes

Purpose

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.

Condition
Autism Spectrum Disorders

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Cross-Sectional
Official Title:	A Characterization Study of Individuals With Autism Spectrum Disorders

Resource links provided by NLM:

Genetics Home Reference related topics: Asperger syndrome

MedlinePlus related topics: Autism

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Overall level of functioning of children and adults with autism spectrum disorders (ASD) compared to individuals without ASD. [ Time Frame: single time point ] [ Designated as safety issue: No ]

Enrollment:	26
Study Start Date:	October 2008
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility

Ages Eligible for Study:	6 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801554

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Joseph Biederman, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00801554 History of Changes
Other Study ID Numbers:	2007-P-001951
Study First Received:	December 2, 2008
Last Updated:	April 12, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Autism Spectrum Disorder
ASD
Autism
Asperger's Syndrome

PDD-NOS
Pervasive Developmental Disorders- Not Otherwise Specified
Adults
Children

Additional relevant MeSH terms:

Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013

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