- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04678245
Network Intervention to Prevent Vaping
Testing Peer-led Network Intervention to Prevent Adolescent Vaping
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States, 14642
- University of Rochester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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).
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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.
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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.
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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
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Self-report of e-cigarette use of any kind in the past 30 days (Johnston, et al., 2019)
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28 months
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Number of participants with any past 30 day nicotine vaping
Time Frame: 28 months
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self-report of e-cigarette use with nicotine product in the past 30 days (Johnston, et al., 2019)
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28 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score Electronic Vaping Product Harm
Time Frame: 28 months
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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.
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28 months
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Mean Electronic Vaping Product Attitudes
Time Frame: 28 months
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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.
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28 months
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Total Number of Trusted Adults
Time Frame: 28 months
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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).
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28 months
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Collaborators and Investigators
Publications and helpful links
General Publications
- Ajzen I. Nature and operation of attitudes. Annu Rev Psychol. 2001;52:27-58. doi: 10.1146/annurev.psych.52.1.27.
- Johnston, 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R01DA050991 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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