Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT04467034
Status:
WITHDRAWN
Last Update Posted:
2022-08-23
First Post:
2020-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of The Stanford Tobacco Prevention Toolkit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Schools were unable to participate due the COVID-19 pandemic, which shifted educational priorities and therefore impeded school-based recruiting efforts. No participants were enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-07-07', 'lastUpdatePostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in resistance to use of tobacco products scaled score as measured by investigator-originated survey', 'timeFrame': 'Change from baseline to follow-up at approximately 40 weeks post-baseline', 'description': "This survey measures change in resistance to use of tobacco products with questions related to the participant's intention to use tobacco."}], 'secondaryOutcomes': [{'measure': 'Change in skills for refusal of tobacco products scaled score as measured by investigator-originated survey', 'timeFrame': 'Change from baseline to follow-up at approximately 40 weeks post-baseline', 'description': "This survey measures change in skills to refuse tobacco use with questions related to the participant's susceptibility to tobacco use, self-efficacy and self-confidence."}, {'measure': 'Change in knowledge of tobacco products scaled score as measured by investigator-originated survey', 'timeFrame': 'Change from baseline to follow-up at approximately 40 weeks post-baseline', 'description': "This survey measures knowledge of tobacco products with questions related to the participant's knowledge of ingredients, of nicotine levels, of potential health outcomes."}, {'measure': "This survey measures use of tobacco products with questions related to the participant's ever tobacco use, past 30-day tobacco use, and past 7-day tobacco use.", 'timeFrame': 'Change from baseline to follow-up at approximately 40 weeks post-baseline', 'description': 'Investigator-originated survey survey measures (questions) assess ever tobacco use, past 30-day tobacco use, past 7-day tobacco use This outcome measure assesses tobacco products use.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['children', 'young adults', 'tobacco', 'education', 'health', 'smoking', 'prevention'], 'conditions': ['Behavior, Health', 'Behavior, Smoking']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://med.stanford.edu/tobaccopreventiontoolkit.html', 'label': 'Stanford Tobacco Prevention Toolkit'}]}, 'descriptionModule': {'briefSummary': "The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by educators and health professionals in providing tobacco-specific prevention education to middle and high school students. The aims of this study are to determine: (1) whether the Curriculum is effective in changing middle and high school students' resistance to using tobacco as well as knowledge of, attitudes towards, and intentions to use different tobacco products; and (2) whether the Curriculum is effective in changing middle and high school students' actual use of tobacco in the short-term."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Middle school and high school students\n\nExclusion Criteria:\n\n* Non English-speakers'}, 'identificationModule': {'nctId': 'NCT04467034', 'briefTitle': 'Evaluation of The Stanford Tobacco Prevention Toolkit', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Randomized Controlled Trial to Evaluate The Stanford Tobacco Prevention Toolkit', 'orgStudyIdInfo': {'id': '54817'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Receives Stanford tobacco education curriculum', 'description': 'Stanford Tobacco Prevention Toolkit is administered.', 'interventionNames': ['Behavioral: Stanford Tobacco Prevention Toolkit curriculum']}, {'type': 'NO_INTERVENTION', 'label': 'Does not receive Stanford tobacco education curriculum', 'description': 'Receives another curriculum or no tobacco education.'}], 'interventions': [{'name': 'Stanford Tobacco Prevention Toolkit curriculum', 'type': 'BEHAVIORAL', 'description': 'Stanford Toolkit curriculum delivered as a 5-session course in a school classroom setting.', 'armGroupLabels': ['Receives Stanford tobacco education curriculum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Bonnie L Halpern-Felsher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford School of Medicine, Department of Pediatrics'}, {'name': 'Michael Baiocchi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford School of Medicine, Department of Epidemiology and Population Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tobacco Related Disease Research Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Bonnie Halpern-Felsher', 'investigatorAffiliation': 'Stanford University'}}}}