Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT06146634
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-18
First Post:
2023-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Washington State Driving Intervention Research Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8000}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2023-11-17', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Crashes', 'timeFrame': 'Post-licensure up to 12 months', 'description': 'The number of participant-involved crashes.'}, {'measure': 'Number of Near-crashes', 'timeFrame': 'Post-licensure up to 12 months', 'description': 'The number of participant-involved near-crashes.'}, {'measure': 'Longitudinal g-force events', 'timeFrame': 'Post-licensure up to 12 months', 'description': 'Significant longitudinal g-force events greater than 0.5 g'}, {'measure': 'Lateral g-force events', 'timeFrame': 'Post-licensure up to 12 months', 'description': 'Significant lateral g-force events greater than 0.5 g'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Driving Behavior']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test the effect of hazard perception and attention maintenance training and testing on driving performance. Participants will be randomized into a treatment group receiving hazard perception or attention maintenance training or a control group receiving either vehicle maintenance training or the status quo ZED training. Randomization will occur by location. Researchers will compare the treatment and control groups to see if there are differences in driving behavior and crash rates.', 'detailedDescription': "The experiment's purpose is to assess the performance of the investigator's novel Driving Hazard Perception and Attention Maintenance training intervention on improving related driving skills, performance in driving exams, and long-term benefits as assessed by crash statistics and naturalistic driving behavior. A two-group pre-post experimental design will be used to evaluate the effectiveness of the new Driving Hazard Perception Training. Each training (hazard perception and attention maintenance) will be assessed in relation to the status quo (ZED training) and in relation to a placebo that has no training related to hazard perception or attention maintenance (vehicle maintenance training). Participants beginning a driver education program will be recruited. Each participating location will be randomized to one of the four research arms. Baseline hazard perception assessment will be performed first, and then participants will receive one of the four trainings. Lastly, all participants will take a hazard perception exam to assess the participants' performance. All participants will also use a smartphone application to collect driving data during the learner driver period and 12 months of independent driving. Driving behaviors and state-level crash data will be used to assess the impact of the interventions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Enrollment in a driver training course through the 911 driving school in Washington State.\n\nExclusion Criteria:\n\n* Participants must meet the above criteria.\n* Additionally, participants will be excluded if either the participant or the participant's parent opts-out."}, 'identificationModule': {'nctId': 'NCT06146634', 'briefTitle': 'Washington State Driving Intervention Research Study', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Washington State Driving Intervention Research Study', 'orgStudyIdInfo': {'id': 'IRB00025991'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hazard Perception Training', 'interventionNames': ['Behavioral: Hazard Perception Training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Maintenance Training', 'interventionNames': ['Behavioral: Vehicle Maintenance Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention Maintenance Training', 'interventionNames': ['Behavioral: Attention Maintenance Training']}, {'type': 'NO_INTERVENTION', 'label': 'ZED Training'}], 'interventions': [{'name': 'Hazard Perception Training', 'type': 'BEHAVIORAL', 'description': 'The hazard perception training is comprised of three modules. Each module is comprised of four scenarios. Each hazard perception scenario has two activities. The entire training is expected to take approximately an hour to complete.', 'armGroupLabels': ['Hazard Perception Training']}, {'name': 'Vehicle Maintenance Training', 'type': 'BEHAVIORAL', 'description': 'For participants randomized into the placebo group, they will receive a brief training on vehicle maintenance using a series of short videos. These videos describe regular checks that drivers should do, such as checking windshield wiper fluid levels, and how to change engine oil. Altogether the videos will last approximately 1 hour.', 'armGroupLabels': ['Vehicle Maintenance Training']}, {'name': 'Attention Maintenance Training', 'type': 'BEHAVIORAL', 'description': 'The attention maintenance training is comprised of three modules. Each module is comprised of four scenarios, with each scenario corresponding to one activity. The entire training is expected to take approximately an hour to complete.', 'armGroupLabels': ['Attention Maintenance Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98125', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'The Driver Training Group', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Johnathon Ehsani, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Academy of Sciences', 'class': 'UNKNOWN'}, {'name': 'The Driver Training Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}