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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

December 2, 2008
April 12, 2011
October 2008
April 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00801554 on ClinicalTrials.gov Archive Site
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Autism Spectrum Disorders (ASD) Characterization Study
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

Children and adults with ASDs.

Controls: healthy volunteers who have never been diagnosed with an Autism Spectrum Disorder.
Autism Spectrum Disorders
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
6 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00801554
2007-P-001951
No
Joseph Biederman, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP