Identifying Student Opinion Leaders to Lead E-cigarette Interventions

Not Applicable

Terminated

• Conditions: E-Cig Use; Adolescent Behavior
• Interventions: Behavioral: Peer-Led Non-Elected Intervention; Behavioral: Peer-Led Peer-Elected Intervention; Behavioral: Adult-Led Intervention

• Registration Number: NCT04083469
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-10
• Study Start: 2019-10-15
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-03
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 686

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer-Led Non-Elected Intervention	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.
Peer-Led Peer-Elected Intervention	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.
Adult-Led Intervention	Adult-Led Intervention	The e-cigarette intervention program will be administered to students by an adult educator.

Primary Outcome Measures

Name	Time	Method
Acceptability: follow-up survey	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.
Feasibility: recruitment and retention rates	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

Name	Time	Method
Intention-to-use and knowledge about e-cigarettes (based on National Youth Tobacco Survey)	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.

Trial Locations

Locations (1)

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States