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OpenTrials
Completed

NCT Number: NCT04678245

Network Intervention to Prevent Vaping

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.

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Key information

Conditions

Vaping Behavior Preventive Psychiatry Smoking Social Networking

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Above the Influence-Vaping (ATI-V)

Behavioral

Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA; not enrolled subjects) will attend a half day ATI-V AA training and the PL training. The training day builds leadership skills in the PLs, develops skills for rising above pressure to vape including identification of personal reasons to rise, identification of healthy support people, teaching accurate use statistics, and sharing stories of prior success in rising above negative pressures. The ATI-V team of PLs and AAs then will run four interactive messaging campaigns to reach the rest of the student body. These four campaigns are (1) Introduction to ATI-V and My Reasons to Rise (2) Gain and Loss (3) Who's Got My Back (4) The Facts. Each campaign features a portion in which PLs model healthy norms and behaviors, and a second portion in which all the rest of the students engage in an interactive component to build and demonstrate the target skill.

Primary outcomes

  1. Number of Participants With Any Past 30 Day Any Vaping

    Time frame: 28 months

    Self reported use of any electronic vaping product during the past 30 days, assessed using participant questionnaire. The outcome is reported as the number of participants reporting any vaping within the previous 30 days.

  2. Number of Participants With Any Past 30 Day Nicotine Vaping

    Time frame: 28 months

    Self reported nicotine containing electronic vaping product use during the previous 30 days, assessed by participant questionnaire. The outcome is reported as the number of participants reporting nicotine vaping.

Secondary outcomes

  1. Score Electronic Vaping Product Harm

    Time frame: 28 months

    Perceived harm of electronic vaping products was assessed using a single questionnaire item scored from 0 (No risk) to 3 (Great risk). Higher scores indicate greater perceived harm.

  2. Mean Electronic Vaping Product Attitudes

    Time frame: 28 months

    Attitudes toward electronic vaping products were assessed using participant responses to 7 items evaluating whether vaping is good, fun, interesting, or exciting. Responses were averaged to produce a mean score ranging from 1 (Strongly disagree) to 5 (Strongly agree). Higher scores indicate more favorable attitudes toward vaping.

  3. Total Number of Trusted Adults

    Time frame: 28 months

    Participants identified trusted adults at school with whom they could discuss personal concerns. The outcome is reported as the total number of trusted adults identified (range 0 to 7).

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Claremont Graduate University
  • National Institute on Drug Abuse (NIDA)
  • Penn State University
  • Texas Tech University
  • University of North Carolina, Chapel Hill

Registry information

Official study title

Testing Peer-led Network Intervention to Prevent Adolescent Vaping

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2020
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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