VapingNCT04678245
Network Intervention to Prevent Vaping
A study testing Above the Influence-Vaping (ATI-V) in people with Vaping and Preventive Psychiatry, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaping, Preventive Psychiatry, Social Networking
- What is being tested?
- Above the Influence-Vaping (ATI-V)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,950 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 4 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- non-English speaking students
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vaping, Preventive Psychiatry, Social Networking
- Being tested
- Above the Influence-Vaping (ATI-V)
- Keywords
- preventive intervention, e-cigarettes, middle school, high school, messaging, network informed prevention
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Above the Influence-Vaping (ATI-V)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Above the Influence-Vaping Intervention | Experimental | 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). Receives: Behavioral: Above the Influence-Vaping (ATI-V) |
| Delayed Above the Influence-Vaping Intervention | Active comparator | 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. Receives: Behavioral: Above the Influence-Vaping (ATI-V) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Past 30 Day Any Vaping
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.
Measured: 28 months
Number of Participants With Any Past 30 Day Nicotine Vaping
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.
Measured: 28 months
Secondary outcomes (3)
Score Electronic Vaping Product Harm
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.
Measured: 28 months
Mean Electronic Vaping Product Attitudes
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.
Measured: 28 months
Total Number of Trusted Adults
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).
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Sep 2020
- Primary completion28 Feb 2025
- Study completion4 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for VapingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Immediate intervention and delayed intervention groups - by school over 2 cohorts
- Masking
- None (open label)
- Enrolment
- 3,950 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Texas Tech University, Claremont Graduate University, Penn State University, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Peter A. Wyman, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678245
- Sponsor's protocol ID
- 1R01DA050991
- Other IDs
- 1R01DA050991
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2020
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Ajzen I. Nature and operation of attitudes. Annu Rev Psychol. 2001;52:27-58. doi: 10.1146/annurev.psych.52.1.27.
PubMed 11148298Johnston, L. D., Miech, R. A., O'Malley, P. M., Bachman, J. G., Schulenberg, J. E., & Patrick, M. E. (2019). Monitoring the Future National Survey Results on Drug Use, 1975-2018: Overview, Key Findings on Adolescent Drug Use. Institute for Social Research.
Wyman PA, Pickering TA, Pisani AR, Rulison K, Schmeelk-Cone K, Hartley C, Gould M, Caine ED, LoMurray M, Brown CH, Valente TW. Peer-adult network structure and suicide attempts in 38 high schools: implications for network-informed suicide prevention. J Child Psychol Psychiatry. 2019 Oct;60(10):1065-1075. doi: 10.1111/jcpp.13102. Epub 2019 Aug 8.
PubMed 31392720
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Peer-led Network Intervention to Prevent Adolescent Vaping
- ClinicalTrials.gov ID
- NCT04678245
- Acronym / sponsor ID
- 1R01DA050991
- Conditions
- Vaping, Preventive Psychiatry, Social Networking
- Keywords
- preventive intervention, e-cigarettes, middle school, high school, messaging, network informed prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,950 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Texas Tech University, Claremont Graduate University, Penn State University, University of North Carolina, Chapel Hill
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 4 Oct 2025 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Posted 26 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Immediate intervention and delayed intervention groups - by school over 2 cohorts
| Arm | Type | Receives |
|---|---|---|
| Immediate Above the Influence-Vaping Intervention | Experimental | Behavioral: 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 | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- non-English speaking students
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Above 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. | Behavioural | Delayed Above the Influence-Vaping Intervention, Immediate Above the Influence-Vaping Intervention |
Primary outcome
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.
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.
3 secondary outcomes
Score Electronic Vaping Product Harm
Time frame: 28 months
Mean Electronic Vaping Product Attitudes
Time frame: 28 months
Total Number of Trusted Adults
Time frame: 28 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11148298Ajzen I. Nature and operation of attitudes. Annu Rev Psychol. 2001;52:27-58. doi: 10.1146/annurev.psych.52.1.27.
- BackgroundJohnston, L. D., Miech, R. A., O'Malley, P. M., Bachman, J. G., Schulenberg, J. E., & Patrick, M. E. (2019). Monitoring the Future National Survey Results on Drug Use, 1975-2018: Overview, Key Findings on Adolescent Drug Use. Institute for Social Research.
- Background: PubMed 31392720Wyman PA, Pickering TA, Pisani AR, Rulison K, Schmeelk-Cone K, Hartley C, Gould M, Caine ED, LoMurray M, Brown CH, Valente TW. Peer-adult network structure and suicide attempts in 38 high schools: implications for network-informed suicide prevention. J Child Psychol Psychiatry. 2019 Oct;60(10):1065-1075. doi: 10.1111/jcpp.13102. Epub 2019 Aug 8.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Vaping
Recruiting
Pilot Study of Communication for Dual Users of Cigarettes and E-cigarettes
Tobacco Products, Cigarettes
Recruiting
Circuit Breathing Exercise on Smoking Cessation Among Youth E-Cigarette Users
E Cigarette Use
Recruiting
A Behavioral Circuit Breathing Training Intervention on Smoking Cessation and Respiratory Function Among Youth Who Use E-cigarettes
E Cigarette Use
Not yet recruiting
Cardiovascular Impacts of E-cigarettes Among Older Adults
Hypertension, Tobacco Cigarette Smoking
Enrolling by invitationObservational study
Study of Vaping Use Among Adolescent and Young Adult Patients With Cancer
Cancer, Vaping
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Above the Influence-Vaping (ATI-V) in people with Vaping and Preventive Psychiatry, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any Past 30 Day Any Vaping (time frame: 28 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04678245, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.