Clinical trial NCT04083469: Identifying Student Opinion Leaders to Lead E-cigarette Interventions
Official title: Identifying Student Opinion Leaders to Lead E-cigarette Interventions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: E-Cig Use
Adolescent Behavior
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center
First posted: 2019-09-10
Enrollment: 686
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Acceptability: follow-up survey
timeFrame: 5 months
measure: Feasibility: recruitment and retention rates
timeFrame: 5 months
Secondary outcomes:
measure: Intention-to-use and knowledge about e-cigarettes (based on National Youth Tobacco Survey)
timeFrame: 5 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kar-Hai Chu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.