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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014