Identifying Student Opinion Leaders to Lead E-cigarette Interventions

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.

Study Overview

• Status: Terminated
• Conditions: Adolescent Behavior; E-Cig Use
• Intervention / Treatment: Behavioral: Peer-Led Peer-Elected Intervention; Behavioral: Adult-Led Intervention; Behavioral: Peer-Led Non-Elected Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 686
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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.
OTHER: 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability: follow-up survey	Acceptability of the intervention will be assessed via the follow-up survey administrated to students following the program.; Do you feel the lessons were appropriate for the subject?; Were you confident in the person conducting the lesson? Questions will be measured in a 5 point Likert scale.	5 months
Feasibility: recruitment and retention rates	Feasibility of the intervention will be assessed via the recruitment and retention rates.; Recruitment = number of students who agree to participate / number of students in school; Retention = number of students who completed the program / number of students who began the program	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intention-to-use and knowledge about e-cigarettes (based on National Youth Tobacco Survey)	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.	5 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: University of Pittsburgh Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2019
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (ACTUAL): September 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 3, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: STUDY19040095

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No