Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT01263756
Status:
COMPLETED
Last Update Posted:
2011-12-08
First Post:
2010-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autism Spectrum Disorders (ASD) Driving Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-06', 'studyFirstSubmitDate': '2010-11-29', 'studyFirstSubmitQcDate': '2010-12-20', 'lastUpdatePostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simulated driving performance of adolescents and adults with ASDs.', 'timeFrame': 'one-time observation (3 hour assessment)', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Questionnaire measures of driving history and behavior of adolescents and adults with ASDs.', 'timeFrame': 'one-time assessment (2-6 hour screening visit)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Driving', 'Autism Spectrum Disorders', 'ASD', 'Attention Deficits', 'Adults', 'Adolescents', 'Pervasive Developmental Disorders'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents and adults, ages 16-50, with Autism Spectrum Disorders.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female patients, aged 16-50 years\n* Identification as having ASD from a prior diagnosis or participation in community conferences for individuals with ASD\n\nExclusion Criteria:\n\n* Major sensorimotor handicaps (e.g. deafness, blindness)\n* Inadequate command of the English language\n* Individuals who have never held a valid driver's license\n* Mental retardation (IQ \\< 80)"}, 'identificationModule': {'nctId': 'NCT01263756', 'briefTitle': 'Autism Spectrum Disorders (ASD) Driving Study', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Study of the Driving Performance of Individuals With Autism Spectrum Disorders', 'orgStudyIdInfo': {'id': '2010-P-000173'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASD group', 'description': 'Adolescents and adults with Autism Spectrum Disorders (ASDs).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Joseph Biederman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD', 'investigatorFullName': 'Joseph Biederman, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}