Autism Spectrum Disorders (ASD) Characterization Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00801554
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : October 22, 2013
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Brief Summary:
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 or disease
Autism Spectrum Disorders

Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Characterization Study of Individuals With Autism Spectrum Disorders
Study Start Date : October 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Children and adults with Autism Spectrum Disorders.
Healthy volunteers who have never been diagnosed with an Autism Spectrum Disorder in their lifetime.

Primary Outcome Measures :
  1. Overall level of functioning of children and adults with autism spectrum disorders (ASD) compared to individuals without ASD. [ Time Frame: single time point ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00801554

United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital

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 Identifier: NCT00801554     History of Changes
Other Study ID Numbers: 2007-P-001951
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: October 22, 2013
Last Verified: October 2013

Keywords provided by Joseph Biederman, MD, Massachusetts General Hospital:
Autism Spectrum Disorder
Asperger's Syndrome
Pervasive Developmental Disorders- Not Otherwise Specified

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders