Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-22 @ 7:55 AM
Study NCT ID:
NCT04083469
Status:
TERMINATED
Last Update Posted:
2020-07-07
First Post:
2019-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Student Opinion Leaders to Lead E-cigarette Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D000294', 'term': 'Adolescent Behavior'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Investigators will conduct a social network survey for 6th graders. Students will be asked to identify their close peers based on several dynamics: friendship, opinion leadership, academic support, and personal support. Social network analyses will identify opinion leaders based on network centrality measures. Surveys will be administered before and after the intervention.\n\nInvestigators will adapt modules from CATCH My Breath, an evidence-based e-cigarette intervention supported by University of Texas and MD Anderson Cancer Center. The 8 schools will be randomized to receive the intervention led by either (1)an adult content-expert or (2)a peer-nominated opinion leader to students who nominated them or (3)a peer-nominated opinion leader to students who did not nominate them. Primary outcomes will be acceptability and feasibility measures, including (1)recruitment and (2)retention rates. Secondary outcomes will include intention-to-use e-cigarettes and knowledge about e-cigarettes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 686}}, 'statusModule': {'whyStopped': 'Covid-19 resulted in school closures.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-03', 'studyFirstSubmitDate': '2019-08-19', 'studyFirstSubmitQcDate': '2019-09-09', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability: follow-up survey', 'timeFrame': '5 months', 'description': 'Acceptability of the intervention will be assessed via the follow-up survey administrated to students following the program.\n\n1. Do you feel the lessons were appropriate for the subject?\n2. Were you confident in the person conducting the lesson?\n\nQuestions will be measured in a 5 point Likert scale.'}, {'measure': 'Feasibility: recruitment and retention rates', 'timeFrame': '5 months', 'description': 'Feasibility of the intervention will be assessed via the recruitment and retention rates.\n\n1. Recruitment = number of students who agree to participate / number of students in school\n2. Retention = number of students who completed the program / number of students who began the program'}], 'secondaryOutcomes': [{'measure': 'Intention-to-use and knowledge about e-cigarettes (based on National Youth Tobacco Survey)', 'timeFrame': '5 months', 'description': 'Intention-to-use and knowledge about e-cigarettes will be assessed via the e-cigarette survey that will be administered after the program. Measures are adapted from the National Youth Tobacco Survey.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['E-Cig Use', 'Adolescent Behavior']}, 'referencesModule': {'references': [{'pmid': '33407805', 'type': 'DERIVED', 'citation': 'Chu KH, Matheny S, Furek A, Sidani J, Radio S, Miller E, Valente T, Robertson L. Identifying student opinion leaders to lead e-cigarette interventions: protocol for a randomized controlled pragmatic trial. Trials. 2021 Jan 6;22(1):31. doi: 10.1186/s13063-020-04990-z.'}]}, 'descriptionModule': {'briefSummary': 'This research will explore the feasibility of leveraging social network analysis to identify 6th grade opinion leaders to lead a school-based e-cigarette intervention. The project will be conducted for 6th graders in 8 schools in the Pittsburgh area.', 'detailedDescription': 'Specific Aim 1: Participants will be recruited from 8 Pittsburgh-area schools. The investigators will conduct a social network survey for all 6th graders in each school. Students will be asked to identify their closest peers based on several relationship dynamics: friendship, opinion leadership, academic support, and personal support.\n\nSpecific Aim 2: The investigators will adapt modules from CATCH My Breath, an evidence-based, school-implemented e-cigarette intervention supported by University of Texas and MD Anderson Cancer Center. The 8 schools will be randomized to receive the intervention led by either (1) an adult content-expert or (2) a peer-nominated opinion leader to students who nominated them or (3) a peer-nominated opinion leader to students who did not nominate them. Surveys will be administered before and after the intervention. Primary outcomes will be acceptability and feasibility measures, including (1) recruitment and (2) retention rates. Secondary outcomes will include e-cigarette use, intention-to-use e-cigarettes, and knowledge about e-cigarettes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 6th grade student at Linton, Founder's Hall, Woodland Hills, Steel Valley, Greensburgh Salem, Freedom, Marion, or Rostraver schools\n\nExclusion Criteria:\n\n* Students who are unable to read the surveys will be excluded from data collection. However, all students will still participate in the e-cigarette program"}, 'identificationModule': {'nctId': 'NCT04083469', 'briefTitle': 'Identifying Student Opinion Leaders to Lead E-cigarette Interventions', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Identifying Student Opinion Leaders to Lead E-cigarette Interventions', 'orgStudyIdInfo': {'id': 'STUDY19040095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peer-Led Peer-Elected Intervention', 'description': 'The e-cigarette intervention program will be administered to students by an elected peer leader. The audience will consist of students that nominated the peer-leader.', 'interventionNames': ['Behavioral: Peer-Led Peer-Elected Intervention']}, {'type': 'OTHER', 'label': 'Adult-Led Intervention', 'description': 'The e-cigarette intervention program will be administered to students by an adult educator.', 'interventionNames': ['Behavioral: Adult-Led Intervention']}, {'type': 'OTHER', 'label': 'Peer-Led Non-Elected Intervention', 'description': 'The e-cigarette intervention program will be administered to students by an elected peer leader. The audience will consist of students that nominated a different peer-leader.', 'interventionNames': ['Behavioral: Peer-Led Non-Elected Intervention']}], 'interventions': [{'name': 'Peer-Led Peer-Elected Intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention will be given to students by a peer opinion leader that the students in the audience elected. The intervention is a version of CATCH My Breath curriculum that has been modified to facilitate peer leadership.', 'armGroupLabels': ['Peer-Led Peer-Elected Intervention']}, {'name': 'Adult-Led Intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention will be given to students by an adult. The intervention is a version of CATCH My Breath curriculum that has been modified to match the Peer-Led Intervention curriculum but is able to be administered by an adult.', 'armGroupLabels': ['Adult-Led Intervention']}, {'name': 'Peer-Led Non-Elected Intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention will be given to students by a peer opinion leader that was elected by other students. The intervention is a version of CATCH My Breath curriculum that has been modified to facilitate peer leadership.', 'armGroupLabels': ['Peer-Led Non-Elected Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Kar-Hai Chu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pittsburgh Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kar-Hai Chu', 'investigatorAffiliation': 'University of Pittsburgh'}}}}