Autism Spectrum Disorders (ASD) Characterization Study

This study is currently recruiting participants.

Verified by Massachusetts General Hospital, December 2008

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00801554

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

MedlinePlus related topics: Autism

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	120
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	October 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	Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Meghan Kotarski, MBA 617-503-1051 mkotarski@partners.org
Contact: Courtney Williams, BA 617-503-1089 cgwilliams@partners.org
Principal Investigator: Joseph Biederman, MD

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Joseph Biederman, MD

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( Joseph Biederman, MD )
Study ID Numbers:	2007-P-001951
Study First Received:	December 2, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00801554
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

Study placed in the following topic categories:

Child Development Disorders, Pervasive
Developmental Disabilities
Mental Disorders

Autistic Disorder
Mental Disorders Diagnosed in Childhood
Asperger Syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009