Network Intervention to Prevent Vaping

NCT04678245 | Active Not Recruiting DMC

• 1 other identifier: 1R01DA050991
• Study Type: interventional
• Target: 3,840
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaping; Preventive Psychiatry; Social Networking

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with any past 30 day any vaping

  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

  self-report of e-cigarette use with nicotine product in the past 30 days (Johnston, et al., 2019)

  28 months

Secondary Outcomes (3)

• Score Electronic Vaping Product Harm

  28 months

• Mean Electronic Vaping Product Attitudes

  28 months

• Total Number of Trusted Adults

  28 months

Study Arms (2)

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).

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.

Behavioral: Above the Influence-Vaping (ATI-V)

Interventions

Above the Influence-Vaping (ATI-V) BEHAVIORAL

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.

Delayed Above the Influence-Vaping Intervention; Immediate Above the Influence-Vaping Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• non-English speaking students

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Texas Tech University: collaborator
• Claremont Graduate University: collaborator
• Penn State University: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (3)

• Ajzen I. Nature and operation of attitudes. Annu Rev Psychol. 2001;52:27-58. doi: 10.1146/annurev.psych.52.1.27.

  PMID: 11148298 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31392720 BACKGROUND

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Immediate intervention and delayed intervention groups - by school over 2 cohorts

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: December 21, 2020
• Study Start: September 1, 2020
• Primary Completion: February 28, 2025
• Study Completion: October 4, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• 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.

Locations

US (1)