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NCT05140915 | Enrolling by invitation | E-cigarette Use


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

University of Massachusetts, Worcester

Information provided by (Responsible Party):

Rajni Sadasivam

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.

Condition or disease

E-cigarette Use

Vaping

Intervention/treatment

Peer Messaging

Peer Coaching via Text

Gamification

E-Cigarette Cessation Materials

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 80 participants
Masking : Single
Primary Purpose : Prevention
Official Title : Vaper to Vaper: A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping
Actual Study Start Date : December 19, 2022
Estimated Primary Completion Date : June 9, 2023
Estimated Study Completion Date : April 30, 2024
Arm Intervention/treatment

Experimental: Intervention

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.

Behavioral: Peer Messaging

Behavioral: Peer Coaching via Text

Active Comparator: Control

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.

Behavioral: Gamification

Other: E-Cigarette Cessation Materials

Ages Eligible for Study: 13 Years to 19 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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).

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

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

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Locations


Not yet recruiting

United States, Massachusetts

UMass Chan Medical School

Worcester, Massachusetts, United States, 01605

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