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Autism Spectrum Disorders (ASD) Driving Study

This study has been completed.
Sponsor:
Collaborator:
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01263756
First received: November 29, 2010
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

The proposed pilot study will begin to assess whether driving impairments are included in the functional deficits associated with Autism Spectrum Disorders (ASDs). This will be completed by obtaining data on velocity, collision risk, and visual attention of subjects with ASDs who drive in a simulator. The study includes 2-3 visits for the screening period (approximately 6 hours of assessments) and one driving simulation visit (approximately 2.5 hours). The investigators expect to enroll 20 adolescents and adults (ages 16-50, inclusive) who have been identified as having an ASD from a prior diagnosis or participation in community conferences for individuals with ASDs.


Condition
Autism Spectrum Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Study of the Driving Performance of Individuals With Autism Spectrum Disorders

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Simulated driving performance of adolescents and adults with ASDs. [ Time Frame: one-time observation (3 hour assessment) ] [ Designated as safety issue: No ]
    Data will be obtained on velocity, collision risk, and visual attention of subjects with ASDs who drive in the driving simulator at the Massachusetts Institute of Technology (MIT).


Secondary Outcome Measures:
  • Questionnaire measures of driving history and behavior of adolescents and adults with ASDs. [ Time Frame: one-time assessment (2-6 hour screening visit) ] [ Designated as safety issue: No ]
    Subjects with ASD will complete two questionnaires, the Driver Behavior Questionnaire and the Driving History Questionnaire, to provide data on the frequency of violations, errors, accidents, and other aspects of driving history and behavior.


Enrollment: 10
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
ASD group
Adolescents and adults with Autism Spectrum Disorders (ASDs).

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adolescents and adults, ages 16-50, with Autism Spectrum Disorders.

Criteria

Inclusion Criteria:

  • Male and female patients, aged 16-50 years
  • Identification as having ASD from a prior diagnosis or participation in community conferences for individuals with ASD

Exclusion Criteria:

  • Major sensorimotor handicaps (e.g. deafness, blindness)
  • Inadequate command of the English language
  • Individuals who have never held a valid driver's license
  • Mental retardation (IQ < 80)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263756

Locations
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Massachusetts Institute of Technology
Investigators
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Joseph Biederman, MD, Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01263756     History of Changes
Other Study ID Numbers: 2010-P-000173
Study First Received: November 29, 2010
Last Updated: December 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Driving
Autism Spectrum Disorders
ASD
Attention Deficits
 Adults
Adolescents
Pervasive Developmental Disorders

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013