We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autism Spectrum Disorders (ASD) Driving 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.
ClinicalTrials.gov Identifier: NCT01263756
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : December 8, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Autism Spectrum Disorder

Study Design

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Study of the Driving Performance of Individuals With Autism Spectrum Disorders
Study Start Date : March 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
ASD group
Adolescents and adults with Autism Spectrum Disorders (ASDs).


Outcome Measures

Primary Outcome Measures :
  1. Simulated driving performance of adolescents and adults with ASDs. [ Time Frame: one-time observation (3 hour assessment) ]
    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 :
  1. Questionnaire measures of driving history and behavior of adolescents and adults with ASDs. [ Time Frame: one-time assessment (2-6 hour screening visit) ]
    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.


Eligibility Criteria

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:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011

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

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