Clinical trial NCT04678245: Network Intervention to Prevent Vaping
Official title: Testing Peer-led Network Intervention to Prevent Adolescent Vaping
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vaping
Preventive Psychiatry
Social Networking
Keywords: preventive intervention
e-cigarettes
middle school
high school
messaging
network informed prevention
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Texas Tech University
name: Claremont Graduate University
name: Penn State University
name: University of North Carolina, Chapel Hill
First posted: 2020-12-21
Enrollment: 3840
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Immediate intervention and delayed intervention groups - by school over 2 cohorts
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with any past 30 day any vaping
timeFrame: 28 months
measure: Number of participants with any past 30 day nicotine vaping
timeFrame: 28 months
Secondary outcomes:
measure: Score Electronic Vaping Product Harm
timeFrame: 28 months
measure: Mean Electronic Vaping Product Attitudes
timeFrame: 28 months
measure: Total Number of Trusted Adults
timeFrame: 28 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
citation: Ajzen I. Nature and operation of attitudes. Annu Rev Psychol. 2001;52:27-58. doi: 10.1146/annurev.psych.52.1.27.
citation: 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.
citation: 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.