- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01263756
Autism Spectrum Disorders (ASD) Driving Study
December 6, 2011 updated by: Joseph Biederman, MD, Massachusetts General Hospital
A Study of the Driving Performance of Individuals With Autism Spectrum Disorders
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Cambridge, Massachusetts, United States, 02138
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adolescents and adults, ages 16-50, with Autism Spectrum Disorders.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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ASD group
Adolescents and adults with Autism Spectrum Disorders (ASDs).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Simulated driving performance of adolescents and adults with ASDs.
Time Frame: one-time observation (3 hour assessment)
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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).
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one-time observation (3 hour assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Questionnaire measures of driving history and behavior of adolescents and adults with ASDs.
Time Frame: one-time assessment (2-6 hour screening visit)
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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.
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one-time assessment (2-6 hour screening visit)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
November 29, 2010
First Submitted That Met QC Criteria
December 20, 2010
First Posted (Estimate)
December 21, 2010
Study Record Updates
Last Update Posted (Estimate)
December 8, 2011
Last Update Submitted That Met QC Criteria
December 6, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-P-000173
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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