跳至主要内容
临床试验/NCT05140915
NCT05140915已完成不适用

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

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2022年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
71
试验地点
2
主要终点
Participant Recruitment and Retention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Participant Recruitment and Retention

时间窗: 3 months

Investigators will assess the number of those screened, eligible, and consented who remain active in the program at 3 months.

次要结局

  • Acceptability of and Satisfaction With the Intervention(3 months)
  • Number of Participants With Abstinence From Vaping as Measured by Saliva Samples [Cotinine-validated 7-day Point Prevalence](3 months)
  • Number of Peer Coaching Interactions(3 months)
  • Number of Peer Videos Viewed(3 months)
  • Number of Games Engaged In(3 months)
  • Change in Self-Efficacy Score(Baseline and 3 months)
  • Number of Participants With With Change in Stage of Change(Baseline and 3 months)
  • Change in Severity of Nicotine Addiction(Baseline and 3 months)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rajani Sadasivam

Professor

University of Massachusetts, Worcester

研究点 (2)

Loading locations...

相似试验

Vaper to Vaper: A Multimodal Mobile Peer Driven... | 临床试验