Autism Spectrum Disorders (ASD) Driving Study

Autism Spectrum Disorder Clinical Trial

Official title:

A Study of the Driving Performance of Individuals With Autism Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263756
• Other study ID #: 2010-P-000173
• Status: Completed
• Phase: N/A
• First received: November 29, 2010
• Last updated: December 6, 2011
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: December 2011
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 50 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simulated driving performance of adolescents and adults with ASDs.	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).	one-time observation (3 hour assessment)	No
Secondary	Questionnaire measures of driving history and behavior of adolescents and adults with ASDs.	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.	one-time assessment (2-6 hour screening visit)	No