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临床试验/NCT04678245
NCT04678245已完成不适用

Testing Peer-led Network Intervention to Prevent Adolescent Vaping

University of Rochester2 个研究点 分布在 1 个国家目标入组 3,950 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,950
试验地点
2
主要终点
Number of participants with any past 30 day nicotine vaping

研究概览

简要总结

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.

详细描述

Above the Influence of Vaping (ATI-V) trains peer nominated 8th-9th grade Peer Leader, and adult advisors. Peer Leaders learn skills and implement school-wide prevention campaigns informed by communication science.New York State has provided funds to support schools to implement ATI-V but no funds for efficacy research. With support from New York State and a strong team of investigators, our project has two aims:

Aim 1. Efficacy. The primary aim of this study is to determine ATI-V impact in preventing vaping use (past 30 days any vaping, nicotine vaping, and regular use). Using an RCT design, 20 schools will be assigned to (a) immediate ATI-V, or (b) wait-list for ATI-V training after 24 months. Approximately 3,800 8th graders will be enrolled and followed for assessments in fall 8th grade, spring 8th grade, spring 9th grade, and mid-year 10th grade. We will test for which students ATI-V is most effective and in what school contexts (school climate).

Aim 2. Mechanism. The second aim of this study to test the hypothesized mechanisms of ATI-V impact. To accomplish this aim we will conduct statistical analyses of a mediation model to determine (a) whether ATI-V improves students' perceptions that vaping is unacceptable to their peers (anti-vaping norms), connections to supportive adults to address EVP concerns, and social influence of non-vaping students; and (b) whether the impact of ATI-V on reduced vaping behavior is mediated by these improvements.

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
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • non-English speaking students

结局指标

主要结局

Number of participants with any past 30 day nicotine vaping

时间窗: 28 months

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

Number of participants with any past 30 day any vaping

时间窗: 28 months

Self-report of e-cigarette use of any kind in the past 30 days (Johnston, et al., 2019)

Number of Participants With Any Past 30 Day Any Vaping

时间窗: 28 months

Self reported use of any electronic vaping product during the past 30 days, assessed using participant questionnaire. The outcome is reported as the number of participants reporting any vaping within the previous 30 days.

Number of Participants With Any Past 30 Day Nicotine Vaping

时间窗: 28 months

Self reported nicotine containing electronic vaping product use during the previous 30 days, assessed by participant questionnaire. The outcome is reported as the number of participants reporting nicotine vaping.

次要结局

  • Score Electronic Vaping Product Harm(28 months)
  • Total Number of Trusted Adults(28 months)
  • Mean Electronic Vaping Product Attitudes(28 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter A. Wyman

Professor

University of Rochester

研究点 (2)

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