Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-30 @ 1:17 AM
Study NCT ID:
NCT01173835
Status:
COMPLETED
Last Update Posted:
2012-07-04
First Post:
2010-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incentive-based Intervention for Smoking Cessation and Prevention in High Schools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072278', 'term': 'Forkhead Box Protein M1'}], 'ancestors': [{'id': 'D051858', 'term': 'Forkhead Transcription Factors'}, {'id': 'D051540', 'term': 'Winged-Helix Transcription Factors'}, {'id': 'D004268', 'term': 'DNA-Binding Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014157', 'term': 'Transcription Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1651}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-02', 'studyFirstSubmitDate': '2010-07-29', 'studyFirstSubmitQcDate': '2010-07-30', 'lastUpdatePostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of students who join the tobacco free program', 'timeFrame': 'at the end of each academic year'}], 'secondaryOutcomes': [{'measure': 'Change in tobacco use rates and attitudes following the intervention exposure', 'timeFrame': 'at the end of each academic year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adolescent tobacco use', 'Tobacco Free and Win', 'Incentive-based intervention', 'Contingency Management', 'Smoking Prevention', 'Smoking cessation'], 'conditions': ['Tobacco Prevention and Cessation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to design an incentive-based intervention to motivate a tobacco-free lifestyle among high school students and to pilot the intervention in the first academic year in two schools (CT and NY) and examine feasibility and acceptability. Preliminary efficacy of the intervention will be assessed by implementing it in two new schools (CT and NY) in the second academic year and determine an effect size estimate for a larger trial.\n\nThe study is intended to assess the number of students joining the program and pledging to be smoke-free and to examine changes in tobacco use rates and attitudes following intervention exposure. We hypothesize that the schools will have lower rates of tobacco use and improvement in attitudes, norms and behavioral control over tobacco use after participating in the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high school student at school that is invited to participate\n\nExclusion Criteria:\n\n* no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT01173835', 'acronym': 'Rise Above', 'briefTitle': 'Incentive-based Intervention for Smoking Cessation and Prevention in High Schools', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Incentive-based Intervention for Smoking Cessation and Prevention in High Schools', 'orgStudyIdInfo': {'id': '0902004736'}, 'secondaryIdInfos': [{'id': 'R01DA026450', 'link': 'https://reporter.nih.gov/quickSearch/R01DA026450', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Incentives for being tobacco free', 'type': 'BEHAVIORAL', 'otherNames': ['Incentive-based program', 'Tobacco Free and Win', 'Contingency Management'], 'description': 'Students who join the program will be entered into regularly scheduled drawings throughout the school year to earn incentives for being tobacco free.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'CMHC, Substance Abuse Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Suchitra Krishnan-Sarin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Suchitra Krishnan-Sarin', 'investigatorAffiliation': 'Yale University'}}}}