Autism Spectrum Disorders (ASD) Characterization Study

Autism Spectrum Disorders Clinical Trial

Official title:

A Characterization Study of Individuals With Autism Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801554
• Other study ID #: 2007-P-001951
• Status: Completed
• Phase: N/A
• First received: December 2, 2008
• Last updated: October 21, 2013
• Start date: October 2008
• Est. completion date: April 2010

Study information

• Verified date: October 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall level of functioning of children and adults with autism spectrum disorders (ASD) compared to individuals without ASD.		single time point	No