Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-10 @ 8:07 PM
Study NCT ID:
NCT04959461
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2021-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Impaired Driving Among Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-05', 'unreleaseDate': '2025-12-08'}, {'releaseDate': '2025-12-08', 'unreleaseDate': '2025-12-11'}, {'releaseDate': '2025-12-12'}], 'estimatedResultsFirstSubmitDate': '2025-12-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Teen participants will be randomized to a single-session, self-guided web-intervention called webCHAT or usual care after completing an online baseline survey. Participants will complete follow-up surveys 3 and 6-months after baseline.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-07-08', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol and/or Cannabis use (scale from Monitoring the Future survey)', 'timeFrame': 'Baseline through month 6', 'description': 'Number of days of alcohol, marijuana, and/or co-use (concurrent and simultaneous) in the past 30 days'}], 'secondaryOutcomes': [{'measure': 'Driving under the influence behaviors (scale from Monitoring the Future survey)', 'timeFrame': 'Baseline through month 6', 'description': 'Number of times they drove a car, motorcycle or other vehicle after using marijuana, alcohol, and/or both in the past 30 days'}, {'measure': 'Passenger driving behavior behaviors (scale from Monitoring the Future survey)', 'timeFrame': 'Baseline through month 6', 'description': 'Number of times they were a passenger in a car or other vehicle with a driver who had beenin the past 30 days drinking alcohol and/or using marijuana'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['impaired driving'], 'conditions': ['Substance-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '36964608', 'type': 'DERIVED', 'citation': "Osilla KC, D'Amico EJ, Smart R, Rodriguez A, Nameth K, Hummer J. Study design to evaluate a web-intervention to prevent alcohol and cannabis-impaired driving and use among adolescents in driver education. Addict Sci Clin Pract. 2023 Mar 24;18(1):17. doi: 10.1186/s13722-023-00373-2."}]}, 'descriptionModule': {'briefSummary': 'The primary goal of this project is to evaluate the efficacy of webCHAT, a single-session web-intervention, on reducing impaired driving among adolescents receiving behind-the-wheel training at driver education programs.', 'detailedDescription': "Alcohol and marijuana (AM) are the most commonly used substances among adolescents in the U.S. The consequences of AM use are significantly higher relative to use of either substance alone. This study builds on effective interventions that have demonstrated reductions in alcohol and/or marijuana use and reduced consequences one year later, and proposes to adapt one of those interventions, CHAT, to the web (web-CHAT). The investigators will evaluate the efficacy of web-CHAT among 15.5-17-year-old adolescents (n=150) recruited when teen participants are attending behind-the-wheel training. The study has the potential to promote public welfare by improving adolescent health outcomes and reducing risky driving behaviors that can have substantial monetary and social costs, as well as by providing unique insight into what mediates reduced risky driving attitudes behaviors among those in the intervention. The study is innovative because it is for both youth who are at risk for substance use as well as those who are not, and it is delivered during a teachable moment when adolescents receive driver's education. Finally, this study can provide unique insights about the efficacy of web-CHAT to reduce marijuana initiation, use, and risky driving attitudes in the context of a changing marijuana policy climate. A 3-year study is proposed to test the feasibility of research procedures in a driver education setting and pilot the efficacy of web-CHAT. The investigators will test whether web-CHAT reduces alcohol and/or marijuana initiation or use compared to teens in UC, at three and six-month follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 15.5-17 year olds enrolled in driver education school\n* Access to a computer or smartphone\n* Within one month of taking their driver's licensing exam\n\nExclusion Criteria:\n\n* Under 15.5 or over 17 years old\n* Not enrolled in one of the participating schools\n* Non-English speaking"}, 'identificationModule': {'nctId': 'NCT04959461', 'acronym': 'webCHAT', 'briefTitle': 'Preventing Impaired Driving Among Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Pilot Trial to Prevent Intoxicated and Impaired Driving Among Adolescents', 'orgStudyIdInfo': {'id': '61874'}, 'secondaryIdInfos': [{'id': 'R34AA027689', 'link': 'https://reporter.nih.gov/quickSearch/R34AA027689', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'webCHAT', 'description': 'Single session 20-40minute self-guided web program that discusses promotes healthy decision making around driving and discusses the risks of alcohol and cannabis-influenced driving.', 'interventionNames': ['Behavioral: webCHAT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Existing driving school education', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'webCHAT', 'type': 'BEHAVIORAL', 'description': 'A self-guided, single session web intervention that utilizes a motivational interviewing style to prevent impaired driving', 'armGroupLabels': ['webCHAT']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': '6 hours of driver education', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ben Baron', 'role': 'CONTACT', 'email': 'benb@BaronEd.com'}], 'facility': 'DriveSafe Driving School', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '48126', 'city': 'Dearborn', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Wilson, BS', 'role': 'CONTACT', 'email': 'RWilson@acg.aaa.com'}], 'facility': 'DriveSafe Driving School', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}], 'centralContacts': [{'name': 'Karen Osilla, PhD', 'role': 'CONTACT', 'email': 'kosilla@stanford.edu', 'phone': '(650) 723-4000'}, {'name': 'Katherine E Nameth, BS', 'role': 'CONTACT', 'email': 'knameth@stanford.edu', 'phone': '6505429699'}], 'overallOfficials': [{'name': 'Karen Osilla, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'After our main intervention effects paper is published; within one year of the final year of funding.', 'ipdSharing': 'YES', 'description': 'Following the NIH Data Sharing Policy and Implementation Guidelines, we plan to make the dataset available for sharing at the time that the main project findings are accepted for publication. That is, the raw data file and codebook, which will initially be used for internal study team purposes, will be available for public use after our main intervention effects paper is published; within one year of the final year of funding.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Karen Osilla', 'investigatorAffiliation': 'Stanford University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-12-05', 'type': 'RELEASE'}, {'date': '2025-12-08', 'type': 'UNRELEASE'}, {'date': '2025-12-08', 'type': 'RELEASE'}, {'date': '2025-12-11', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'Karen Osilla, Associate Professor, Stanford University'}}}}