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Identifying Student Opinion Leaders to Lead E-cigarette Interventions

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ClinicalTrials.gov Identifier: NCT04083469
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
University of Pittsburgh Medical Center
Information provided by (Responsible Party):
Kar-Hai Chu, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
E-Cig Use Adolescent Behavior Behavioral: Peer-Led Peer-Elected Intervention Behavioral: Adult-Led Intervention Behavioral: Peer-Led Non-Elected Intervention Not Applicable

Detailed Description:

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.

Specific 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1517 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Investigators 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.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Identifying Student Opinion Leaders to Lead E-cigarette Interventions
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: Peer-Led Peer-Elected Intervention
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.
Behavioral: Peer-Led Peer-Elected Intervention
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.

Adult-Led Intervention
The e-cigarette intervention program will be administered to students by an adult educator.
Behavioral: Adult-Led Intervention
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.

Peer-Led Non-Elected Intervention
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.
Behavioral: Peer-Led Non-Elected Intervention
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.




Primary Outcome Measures :
  1. Acceptability: follow-up survey [ Time Frame: 5 months ]

    Acceptability of the intervention will be assessed via the follow-up survey administrated to students following the program.

    1. Do you feel the lessons were appropriate for the subject?
    2. Were you confident in the person conducting the lesson?

    Questions will be measured in a 5 point Likert scale.


  2. Feasibility: recruitment and retention rates [ Time Frame: 5 months ]

    Feasibility of the intervention will be assessed via the recruitment and retention rates.

    1. Recruitment = number of students who agree to participate / number of students in school
    2. Retention = number of students who completed the program / number of students who began the program


Secondary Outcome Measures :
  1. Intention-to-use and knowledge about e-cigarettes (based on National Youth Tobacco Survey) [ Time Frame: 5 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 6th grade student at Linton, Founder's Hall, Woodland Hills, Steel Valley, Greensburgh Salem, Freedom, Marion, or Rostraver schools

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083469


Contacts
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Contact: Kar-Hai Chu, PhD 412-692-2578 chuk@pitt.edu

Locations
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United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
University of Pittsburgh Medical Center
Investigators
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Principal Investigator: Kar-Hai Chu, PhD University of Pittsburgh

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Responsible Party: Kar-Hai Chu, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04083469     History of Changes
Other Study ID Numbers: STUDY19040095
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No