Skip to content

Network Intervention to Prevent Vaping

Testing Peer-led Network Intervention to Prevent Adolescent Vaping

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04678245
Enrollment
3950
Registered
2020-12-21
Start date
2020-09-01
Completion date
2025-10-04
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preventive Psychiatry, Social Networking, Vaping

Keywords

preventive intervention, e-cigarettes, middle school, high school, messaging, network informed prevention

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.

Interventions

BEHAVIORALAbove the Influence-Vaping (ATI-V)

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.

Sponsors

University of Rochester
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Texas Tech University
CollaboratorOTHER
Claremont Graduate University
CollaboratorOTHER
Penn State University
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Immediate intervention and delayed intervention groups - by school over 2 cohorts

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Any Past 30 Day Any Vaping28 monthsSelf 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.
Number of Participants With Any Past 30 Day Nicotine Vaping28 monthsSelf 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

MeasureTime frameDescription
Score Electronic Vaping Product Harm28 monthsPerceived 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.
Mean Electronic Vaping Product Attitudes28 monthsAttitudes 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.
Total Number of Trusted Adults28 monthsParticipants 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).

Countries

United States

Participant flow

Recruitment details

Nineteen schools in 14 school districts recruited students across three cohorts. A total of 2,967 students completed the baseline assessment. Additional eligible students entered the study at subsequent assessment waves, resulting in a cumulative enrollment of 3,950 participants. The final analysis sample included 3,515 participants.

Pre-assignment details

The first two cohorts had 4 schools, so two each were assigned to waitlist and intervention. To balance school size, in the third cohort one large district (3 middle schools) was randomized with 3 smaller schools.

Baseline characteristics

Characteristic
30 day any vaping54 Participants
Age, Continuous13.14 years
STANDARD_DEVIATION 0.36
Ethnicity (NIH/OMB)
Hispanic or Latino
203 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2200 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
17 Participants
Race (NIH/OMB)
American Indian or Alaska Native
24 Participants
Race (NIH/OMB)
Asian
71 Participants
Race (NIH/OMB)
Black or African American
163 Participants
Race (NIH/OMB)
More than one race
143 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants
Race (NIH/OMB)
Unknown or Not Reported
463 Participants
Race (NIH/OMB)
White
1852 Participants
Sex/Gender, Customized
Sex
Female
1352 Participants
Sex/Gender, Customized
Sex
Male
747 Participants
Sex/Gender, Customized
Sex
Other/Not Reported
91 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1,8000 / 1,715
other
Total, other adverse events
0 / 1,8000 / 1,715
serious
Total, serious adverse events
0 / 1,8000 / 1,715

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026