Autism Spectrum Disorders (ASD) Characterization Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00801554
First received: December 2, 2008
Last updated: October 21, 2013
Last verified: October 2013
  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:


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, Chief, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD; Professor of Psychiatry, Harvard Medical School, 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: October 21, 2013
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 April 15, 2014