Autism Spectrum Disorders (ASD) Driving Study
This study has been completed.
Sponsor:
Massachusetts General Hospital
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
| Tracking Information | |||||
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| First Received Date ICMJE | November 29, 2010 | ||||
| Last Updated Date | December 6, 2011 | ||||
| Start Date ICMJE | March 2010 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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). |
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| Original Primary Outcome Measures ICMJE |
Simulated driving performance of adolescents and adults with ASDs. [ Time Frame: simulation visit (3 hours) ] [ 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). |
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| Change History | Complete list of historical versions of study NCT01263756 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE |
Questionnaire measures of driving history and behavior of adolescents and adults with ASDs. [ Time Frame: screening visit (2-6 hours) ] [ 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. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Autism Spectrum Disorders (ASD) Driving Study | ||||
| Official Title ICMJE | A Study of the Driving Performance of Individuals With Autism Spectrum Disorders | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adolescents and adults, ages 16-50, with Autism Spectrum Disorders. |
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| Condition ICMJE | Autism Spectrum Disorder | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | ASD group
Adolescents and adults with Autism Spectrum Disorders (ASDs). |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 10 | ||||
| Completion Date | March 2011 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01263756 | ||||
| Other Study ID Numbers ICMJE | 2010-P-000173 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Joseph Biederman, MD, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Massachusetts Institute of Technology | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | December 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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