Identifying Student Opinion Leaders to Lead E-cigarette Interventions

NCT ID: NCT04083469

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

686 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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E-Cig Use Adolescent Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Peer-Led Peer-Elected Intervention

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Adult-Led Intervention

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Peer-Led Non-Elected Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh Medical Center

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Kar-Hai Chu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kar-Hai Chu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33407805 (View on PubMed)

Other Identifiers

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STUDY19040095

Identifier Type: -

Identifier Source: org_study_id

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