Vaper to Vaper: A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping

Not Applicable

Completed

Conditions: Vaping
E-cigarette Use

Interventions: Behavioral: Peer Messaging
Other: E-Cigarette Cessation Materials
Behavioral: Peer Coaching via Text
Behavioral: Gamification

Registration Number: NCT05140915

Lead Sponsor: University of Massachusetts, Worcester

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 71

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Peer Coaching via Text	Students in school randomized to the intervention will receive: (1) peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit; (2) peer coaching, facilitated by texting; and (3) gamification, designed to motivate participation.
Intervention	Peer Messaging	Students in school randomized to the intervention will receive: (1) peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit; (2) peer coaching, facilitated by texting; and (3) gamification, designed to motivate participation.
Intervention	Gamification	Students in school randomized to the intervention will receive: (1) peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit; (2) peer coaching, facilitated by texting; and (3) gamification, designed to motivate participation.
Control	E-Cigarette Cessation Materials	Students in schools randomized to the control condition will be provided written e-cigarette cessation materials by the Research Coordinator at the time of study enrollment. The written materials will consist of two pamphlets from Journeyworks, selected based on: (1) their clear and attractive layout designed for a low-literacy audience, and (2) their providing both information re: e-cigarette use with a strong message about nicotine and nicotine addiction, E-Cigarettes: 8 Things Everyone Should Know, and support in quitting, How to Quit Vaping.

Primary Outcome Measures

Name	Time	Method
Participant Recruitment and Retention	3 months	Investigators will assess the number of those screened, eligible, and consented who remain active in the program at 3 months.

Secondary Outcome Measures

Name	Time	Method
Acceptability of and Satisfaction With the Intervention	3 months	Investigators will access the acceptability of and satisfaction with the intervention, as measured by Client Satisfaction Questionnaire (CSQ-8).The overall CSQ-8 score is calculated by summing the respondent's rating (item rating) score for each scale item. Scores therefore range from 8 to 32, with higher values indicating higher satisfaction. Similarly, investigators will look for association between summary score and cessation.
Number of Participants With Abstinence From Vaping as Measured by Saliva Samples [Cotinine-validated 7-day Point Prevalence]	3 months	Cotinine-validated 7-day point prevalence abstinence, as measured by saliva samples collected from all; analyzed for those reporting 7-day abstinence; cut-off 11.4 ng/ml, cotinine-imputed abstinence when cotinine is missing.
Number of Peer Coaching Interactions	3 months	Investigators will assess the system use (for V2V intervention only), as measured by the number of peer coaching interactions completed.
Number of Peer Videos Viewed	3 months	Investigators will assess the system use (for V2V intervention only), as measured by the self-reported frequency of viewing peer videos.
Number of Games Engaged In	3 months	Investigators will assess the system use (for V2V intervention only), as measured by the self-reported frequency of reading gamification texts.
Change in Self-Efficacy Score	Baseline and 3 months	Assessment of change in self-efficacy, as measured by the Self-efficacy Questionnaire (SEQ-12). The SEQ-12 (Self-Efficacy) Score is the mean of 12 items coded 1 (Not at all confident) to 5 (Extremely Confident). The score can range from 1-5, with higher scores indicating better confidence to refrain from vaping.
Number of Participants With With Change in Stage of Change	Baseline and 3 months	Investigators will also assess the change in stage of change, as measured by Prochaska's Stages of Change model. The stages of change are: Precontemplation, Contemplation, Preparation/Determination, Action/Willpower, Maintenance, and Relapse. Participants will self-report their stage of change at 0 and 3 months.
Change in Severity of Nicotine Addiction	Baseline and 3 months	Investigators will assess the change in the severity of nicotine addiction, as measured by the Hooked on Nicotine Checklist. The Hooked on Nicotine Checklist Score is the sum of 10 items coded 0 (Not endorsed) or 1 (Endorsed). The possible range is 0-10, with higher scores indicating a higher level of addiction.