NCT00801554

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

1.5 years

First QC Date

December 2, 2008

Last Update Submit

October 21, 2013

Conditions

Keywords

Autism Spectrum DisorderASDAutismAsperger's SyndromePDD-NOSPervasive Developmental Disorders- Not Otherwise SpecifiedAdultsChildren

Outcome Measures

Primary Outcomes (1)

  • Overall level of functioning of children and adults with autism spectrum disorders (ASD) compared to individuals without ASD.

    single time point

Study Arms (2)

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 Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adults with ASDs. Controls: healthy volunteers who have never been diagnosed with an Autism Spectrum Disorder.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderAsperger Syndrome

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Joseph Biederman, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD; Professor of Psychiatry, Harvard Medical School

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

October 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations