NCT00801554CompletedNot Applicable
A Characterization Study of Individuals With Autism Spectrum Disorders
Massachusetts General Hospital1 site in 1 country26 target enrollmentStarted: October 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Overall level of functioning of children and adults with autism spectrum disorders (ASD) compared to individuals without ASD.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 6 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Overall level of functioning of children and adults with autism spectrum disorders (ASD) compared to individuals without ASD.
Time Frame: single time point
Secondary Outcomes
No secondary outcomes reported
Investigators
Joseph Biederman, MD
Chief, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD; Professor of Psychiatry, Harvard Medical School
Massachusetts General Hospital
Study Sites (1)
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