Skip to main content
Clinical Trials/NCT04678245
NCT04678245
Active, not recruiting
Not Applicable

Testing Peer-led Network Intervention to Prevent Adolescent Vaping

University of Rochester1 site in 1 country3,840 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vaping
Sponsor
University of Rochester
Enrollment
3840
Locations
1
Primary Endpoint
Number of participants with any past 30 day nicotine vaping
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

Rates of adolescent vaping are increasing rapidly. Current high school student use of electronic vaping products (EVPs) rose from 1.5% in 2011 to 20.8% in 2018 - an increase from 220,000 to 3.05 million adolescent users. Effective, school-based interventions are urgently needed to protect adolescents from initiating or continuing use of electronic vaping products (EVPs). This study leverages a state-supported prevention initiative to test the effectiveness of a promising intervention that trains 8th-9th grade student peer leaders to deliver school-wide vaping prevention campaigns with ongoing adult mentoring. If study hypotheses are supported, the study will provide the first evidence of a school-based preventive intervention that reduces adolescent vaping behaviors, as well as insight into how peer communications can be harnessed to prevent vaping.

Detailed Description

Above the Influence of Vaping (ATI-V) trains peer nominated 8th-9th grade Peer Leader, and adult advisors. Peer Leaders learn skills and implement school-wide prevention campaigns informed by communication science.New York State has provided funds to support schools to implement ATI-V but no funds for efficacy research. With support from New York State and a strong team of investigators, our project has two aims: Aim 1. Efficacy. The primary aim of this study is to determine ATI-V impact in preventing vaping use (past 30 days any vaping, nicotine vaping, and regular use). Using an RCT design, 20 schools will be assigned to (a) immediate ATI-V, or (b) wait-list for ATI-V training after 24 months. Approximately 3,800 8th graders will be enrolled and followed for assessments in fall 8th grade, spring 8th grade, spring 9th grade, and mid-year 10th grade. We will test for which students ATI-V is most effective and in what school contexts (school climate). Aim 2. Mechanism. The second aim of this study to test the hypothesized mechanisms of ATI-V impact. To accomplish this aim we will conduct statistical analyses of a mediation model to determine (a) whether ATI-V improves students' perceptions that vaping is unacceptable to their peers (anti-vaping norms), connections to supportive adults to address EVP concerns, and social influence of non-vaping students; and (b) whether the impact of ATI-V on reduced vaping behavior is mediated by these improvements.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
October 4, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peter A. Wyman

Professor

University of Rochester

Eligibility Criteria

Inclusion Criteria

  • current 8th grade student of study school at start of school participation
  • No person shall be excluded from participation, denied benefits, or discriminated against because of race, color, national origin, sexual orientation, sex, gender identity, age, or ability (i.e., special education status).

Exclusion Criteria

  • non-English speaking students

Outcomes

Primary Outcomes

Number of participants with any past 30 day nicotine vaping

Time Frame: 28 months

self-report of e-cigarette use with nicotine product in the past 30 days (Johnston, et al., 2019)

Number of participants with any past 30 day any vaping

Time Frame: 28 months

Self-report of e-cigarette use of any kind in the past 30 days (Johnston, et al., 2019)

Secondary Outcomes

  • Score Electronic Vaping Product Harm(28 months)
  • Mean Electronic Vaping Product Attitudes(28 months)
  • Total Number of Trusted Adults(28 months)

Study Sites (1)

Loading locations...

Similar Trials