Network Intervention to Prevent Vaping

Not Applicable

Active, not recruiting

• Conditions: Social Networking; Vaping; Preventive Psychiatry
• Interventions: Behavioral: Above the Influence-Vaping (ATI-V)

• Registration Number: NCT04678245
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study First Submitted: 2020-04-02
• Study Start: 2020-09-01
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-21
• Primary Completion: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Study Completion: 2025-10-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3840

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Above the Influence-Vaping Intervention	Above the Influence-Vaping (ATI-V)	School receives Above the Influence-Vaping (ATI-V) prevention program training after baseline assessment. Training and intervention continue over two school years (approximately 18 months). Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade).
Delayed Above the Influence-Vaping Intervention	Above the Influence-Vaping (ATI-V)	Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade). ATI-V prevention program training after 4th assessment - after 28 months.

Primary Outcome Measures

Name	Time	Method
Number of participants with any past 30 day nicotine vaping	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	28 months	Self-report of e-cigarette use of any kind in the past 30 days (Johnston, et al., 2019)

Secondary Outcome Measures

Name	Time	Method
Score Electronic Vaping Product Harm	28 months	self report of 'how much do you think people risk harming themselves (physically or in other ways) when they use electronic vapor products every day?' on a 4 point likert scale of No risk (0) to Great risk (3) (Johnston, et al., 2019) Higher numbers suggest perception of greater harm. This one item scale will range from 0 to 3.
Mean Electronic Vaping Product Attitudes	28 months	mean of self report items of whether vaping is 'good, fun, interesting, exciting' on a 5 point likert scale of Strongly disagree (1) to Strongly agree (5) (Ajzen, 2001). Higher numbers suggest more positive attitudes towards vaping. Scale is mean, so will range from 1 to 5.
Total Number of Trusted Adults	28 months	self report of adults at school students can 'trust or feel you can talk to about personal things'. Can name up to 7 adults - reporting total number (range 0-7).

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States