Clinical trial NCT05140915: Vaper to Vaper: A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping
Official title: Vaper to Vaper: A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: E-cigarette Use
Vaping
Keywords: Vaping
Adolescents
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-12-02
Enrollment: 71
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The dramatic increase in the use of e-cigarettes among U.S. adolescents has been called a national epidemic, with more adolescents now using e-cigarettes than traditional cigarettes. The high amounts of nicotine in e-cigarettes harm adolescents and put them at greater risk of becoming traditional cigarette smokers. The investigators propose to develop Vaper-to-Vaper (V2V), a suite of mobile peer driven tools including peer texting and coaching based on lessons learned in the investigators' prior tobacco intervention work, to engage and help adolescents use strategies to manage cravings and successfully quit.

Detailed description: The FDA and the US Surgeon General call the increasing use of e-cigarettes among U.S. adolescents an epidemic, with e-cigarette use exceeding combustible cigarette use. The high amounts of nicotine in e-cigarettes harm adolescent brain development, impacting learning, memory, and attention. Adolescent e-cigarette users also are at higher risk than non-users of transitioning to traditional cigarettes. While prevention is important, evidence-based interventions to engage and help adolescent e-cigarette users quit are critically needed. Key challenges include adolescents perceiving e-cigarette use to be of low risk resulting in a low intention to quit, and the major influence of peers in e-cigarette use. Given there currently are no evidence-based cessation interventions to assist adolescent e-cigarette users in quitting, as suggested by the American Academy of Pediatrics and FDA, the investigators propose to develop Vaper-to-Vaper (V2V), a multi-modal mobile peer driven intervention, based on lessons learned in our prior tobacco intervention work. Peer-driven interventions have been found to successfully improve smoking outcomes in adolescents, and the investigators have had success in developing peer-driven interventions for low motivated adult smokers. The Investigators therefore will adapt these approaches for adolescent e-cigarette users. V2V's goal will be to engage, educate, motivate, and facilitate the adolescent in using strategies to manage cravings and successfully quit. The V2V components will include: Peer Messaging (tailored messages pushed via texting), Peer Coaching (asynchronous communications with trained coaches via texting), and Gamification (using game design to motivate participation). Adapting these tools to the unique needs of adolescent e-cigarette users will further extend these tools into novel directions. For Aim 1 the investigators will convene a peer advisory panel of 20 adolescent e-cigarette users to participate in a qualitative assessment and further development of V2V components. In Aim 2 the investigators will evaluate the feasibility of the research protocols and the feasibility and acceptability of the V2V intervention in a pilot feasibility study with eighty adolescent e-cigarette users from 4 high schools (schools randomized to either V2V intervention or control) recruited and followed for 6 months. The investigators hypothesize being able to recruit 80 adolescents (20/school, 40 per study condition) and that \>85% will be retained in each study condition at 6-month follow-up (Aim 2A). For Aim 2b the investigators will monitor V2V engagement (e.g., number of V2V texting quizzes completed, peer coaching interactions, peer videos viewed) and assess acceptability of and satisfaction with the program. For Aim 2C the investigators hypothesize that the intervention will be associated with greater cotinine-validated 7-day point prevalence vaping abstinence rates, lower time to first quit attempt, and less amount of e-cigarette use compared to control at 6-month follow-up. This Stage I project, adapting an existing intervention and feasibility/pilot testing, will provide the necessary materials and information to proceed to a subsequent large-scale Stage III R01 trial to test the efficacy of the V2V intervention in supporting adolescent e-cigarette users in quitting.

Eligibility criteria: Inclusion Criteria:

* Enrolled in grade 9-12 at participating high school
* Current e-cigarette user, as defined as a response greater than "0 days" to the question: "During the past 7 days, on how many days did you use e-cigarettes?" This eligibility criterion is modeled on a question in the 2018 National Youth Tobacco Survey (NYTS), a survey of U.S. middle and high school students which used a 30-day timeframe.
* Have a smartphone.
* English- or Spanish-speaking

Exclusion Criteria: Unable or unwilling to provide informed assent or consent (in the case of those aged 18 years or older).

Primary outcomes:
measure: Participant Recruitment and Retention
timeFrame: 3 months
Secondary outcomes:
measure: Acceptability of and Satisfaction With the Intervention
timeFrame: 3 months
measure: Number of Participants With Abstinence From Vaping as Measured by Saliva Samples [Cotinine-validated 7-day Point Prevalence]
timeFrame: 3 months
measure: Number of Peer Coaching Interactions
timeFrame: 3 months
measure: Number of Peer Videos Viewed
timeFrame: 3 months
measure: Number of Games Engaged In
timeFrame: 3 months
measure: Change in Self-Efficacy Score
timeFrame: Baseline and 3 months
measure: Number of Participants With With Change in Stage of Change
timeFrame: Baseline and 3 months
measure: Change in Severity of Nicotine Addiction
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Rajani Sadasivam, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts Chan Medical School
name: Lori Pbert, PhD
role: PRINCIPAL_INVESTIGATOR
References: