Network Intervention to Prevent Vaping

July 11, 2023 updated by: Peter Wyman, University of Rochester

Testing Peer-led Network Intervention to Prevent Adolescent 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.

Study Overview

Status

Enrolling by invitation

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 Type

Interventional

Enrollment (Estimated)

3840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Above the Influence-Vaping Intervention
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).
Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) 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.
Active Comparator: Delayed Above the Influence-Vaping Intervention
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.
Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
28 months
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)
28 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score Electronic Vaping Product Harm
Time Frame: 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.
28 months
Mean Electronic Vaping Product Attitudes
Time Frame: 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.
28 months
Total Number of Trusted Adults
Time Frame: 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).
28 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1R01DA050991 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data (stripped of school names and other identifiers) for all primary and secondary outcome measures will be made available to collaborators and other interested researchers via secure server links.

IPD Sharing Time Frame

Data will be available within 6 months of study completion.

IPD Sharing Access Criteria

Requestors will be required to sign a data access agreement. The data sharing agreement involves sharing only de-identified data with other investigators and the use of data sharing agreements that provide for: (1) a commitment for using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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