Identifying Student Opinion Leaders to Lead E-cigarette Interventions

NCT04083469 | Terminated DMC

• 1 other identifier: STUDY19040095
• Study Type: interventional
• Target: 686
• Locations: 1 country
• Sites: 1

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.

Conditions

E-Cig Use; Adolescent Behavior

Outcome Measures

Primary Outcomes (2)

• Acceptability: follow-up survey

  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.

  5 months

• Feasibility: recruitment and retention rates

  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

  5 months

Secondary Outcomes (1)

• Intention-to-use and knowledge about e-cigarettes (based on National Youth Tobacco Survey)

  5 months

Study Arms (3)

Peer-Led Peer-Elected Intervention

EXPERIMENTAL

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

Adult-Led Intervention

OTHER

The e-cigarette intervention program will be administered to students by an adult educator.

Behavioral: Adult-Led Intervention

Peer-Led Non-Elected Intervention

OTHER

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

Interventions

Peer-Led Peer-Elected Intervention 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.

Peer-Led Peer-Elected Intervention

Adult-Led Intervention 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.

Adult-Led Intervention

Peer-Led Non-Elected Intervention 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.

Peer-Led Non-Elected Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 33407805 DERIVED

MeSH Terms

Conditions

Vaping; Adolescent Behavior

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Kar-Hai Chu, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: September 10, 2019
• Study Start: October 15, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

US (1)