Viewing Study NCT04083469


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Study NCT ID: NCT04083469
Status: TERMINATED
Last Update Posted: 2020-07-07
First Post: 2019-08-19
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Identifying Student Opinion Leaders to Lead E-cigarette Interventions
Sponsor: University of Pittsburgh
Organization:

Study Overview

Official Title: Identifying Student Opinion Leaders to Lead E-cigarette Interventions
Status: TERMINATED
Status Verified Date: 2020-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Covid-19 resulted in school closures.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: