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临床试验/NCT06825338
NCT06825338进行中(未招募)不适用

Investigating the Effectiveness of the 'CATCH My Breath' Vaping Prevention Curriculum at Preventing Vaping Initiation Among High School Students in Ontario, Canada

University of Ontario Institute of Technology8 个研究点 分布在 1 个国家目标入组 5,600 人开始时间: 2025年10月3日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
5,600
试验地点
8
主要终点
Number of participants that initiate vaping at 12-month follow-up

研究概览

简要总结

Vapes (also called e-cigarettes) have increased in popularity among youth in Canada and the United States. Youth who try vaping are at risk of becoming addicted and continuing to vape. To help combat the rise in vaping, there is an urgent need to identify effective ways to prevent youth from experimenting with vaping. Because of the novelty of vapes, there are few school-based programs targeting vaping. This study will investigate whether a vaping prevention curriculum called 'CATCH My Breath' (CMB) prevents high school students from starting to vape.

The investigators will recruit 28 schools in Ontario, Canada into the intervention group, and students at these schools will be presented with the CMB curriculum by Public Health Unit staff. CMB is an evidence-based program that includes two 60-minute lessons that provide students with information about social norms related to vaping, health risks of vaping, media literacy, and in-class activities to practice refusal skills. Students will complete an online survey before being exposed to the curriculum, 3-months later, and 12-months later. The vaping behaviours of these students will be compared to students in a separate study of youth health (i.e., the COMPASS study) who are not given the curriculum.

Evidence from this study will identify whether students exposed to CMB are less likely to start and continue vaping. If effective, CMB can be easily delivered in high schools across Canada in order to reduce the number of students who vape.

详细描述

Background and Importance: Youth vaping (or e-cigarette use) as increased dramatically among youth populations in Canada and the United States. While the long-term negative effects of vaping are relatively unknown, youth who vape are at risk of becoming addicted to nicotine and continuing to vape. Given the novelty of these devices and their rising popularity among youth, there is an urgent need to identify effective prevention approaches.

Research Aims: The goal of this study is to investigate the effectiveness of the 'CATCH My Breath' (CMB) vaping prevention curriculum at preventing vaping initiation among a cohort of high school students in Ontario, Canada. Specifically, this study will identify whether students exposed to CMB have a lower likelihood of 1) initiating vaping, 2) being susceptible to future vaping, and 3) vaping in the past 30-days at 12-month follow-up, compared to a matched comparison group of students. This study will also investigate whether the effects of the intervention differ according to gender. Methods: Intervention. CMB is a school-based vaping prevention curriculum based on best practices from earlier prevention studies and incorporates theory to foster social competence and social influence resistance skills. It is delivered through two 60-minute lessons delivered by a trained presenter. A pilot study identified components of the program that worked well and what needed to be adapted for a Canadian high school context. Sample. A purposive sample of 28 high schools in Ontario will be recruited and Public Health staff will deliver the curriculum to grade 9 students during Physical Education & Health classes. A matched sample of 28 high schools from a larger pool of schools participating in a separate study of youth health (i.e., the COMPASS study) will be selected as a comparison group. A matched sample of students will be identified from comparison group schools. Data collection & analysis. Students in the intervention group (n=2800) will complete an online survey before exposure to the curriculum and 3-months, and 12-months later to identify changes in vaping knowledge, attitudes, and behaviour. Descriptive analysis of baseline data will produce a profile of demographics and baseline characteristics and identify any imbalances between the intervention and comparison groups that should be accounted for in later analyses. Multilevel regression models will test for intervention effects while controlling for baseline differences through the use of covariates. Expected Outcomes: Evidence from this project will identify whether students exposed to CMB are less likely to start vaping, which will support school-based efforts to prevent vaping initiation and experimentation among youth.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • School Inclusion Criteria:
  • public and private schools in Ontario, English-speaking schools, include students in grades 9 through 12, operate in a standard school/classroom setting (i.e., not a virtual school)

排除标准

  • non-English speaking schools, virtual schools, currently using the CATCH My Breath vaping prevention curriculum
  • Student Inclusion Criteria:
  • enrolled in the class in which the CATCH My Breath curriculum is being delivered
  • Student Exclusion Criteria:
  • not enrolled in the class in which the CATCH My Breath curriculum is being delivered

研究组 & 干预措施

CATCH My Breath (CMB)

Experimental

CATCH My Breath (CMB) is a school-based vaping prevention curriculum based on best practices from earlier prevention studies that works by fostering social competence and social influence resistance skills. The curriculum design and content targets two key constructs of Social Cognitive Theory: self-efficacy and behavioural capacity (i.e., knowledge and skills). The curriculum provides students with knowledge of why and how to resist vaping. It is delivered through two 60-minute lessons by a trained Public Health Unit presenter. The curriculum lessons provide information about: 1) the physical, mental, and addiction risks associated with vaping, 2) social norms of vaping (e.g., most youth don't vape), 3) media literacy (e.g., how to recognize and decipher marketing of vapes), 4) strategies to resist and avoid vaping, 5)school and provincial policies about vaping. To solidify the content, in-class activities allow students to discuss what they are learning and practice refusal skills.

干预措施: CATCH My Breath (Other)

Comparison

No Intervention

In Ontario, the current Health and Physical Education curriculum does not include any vaping-specific information, leaving it up to the discretion of educators to decide what to teach and how. The study takes advantage of existing connections to the COMPASS study. The large sample of schools participating in the COMPASS study provides an ideal comparison group, eliminating the need to recruit schools for this condition and reducing costs. The COMPASS study collects information about changes to school programs, policies, and the built environment that may occur over time using the School Policies and Practices survey. This survey is completed annually by a school contact knowledgeable about the school's health-related programs and policies. School contacts are asked whether the school offers any programs that address vaping and tobacco use prevention/cessation. This information will be used to identify schools that have not implemented any vaping/tobacco use programs.

结局指标

主要结局

Number of participants that initiate vaping at 12-month follow-up

时间窗: baseline and 12-month follow-up

One validated item will assess ever vaping: "Have you ever tried a vape, also known as an e-cigarette?", with response options 'Yes' and 'No'. This item is consistent with other youth health surveillance studies in Canada and the US and is already present in the COMPASS survey. The question will include a definition of vapes, including examples and images of common brands, to improve the validity of student responses. Students who respond 'No' at baseline will be categorized as 'Never vapers'. Students who never vaped at baseline who respond 'Yes' at follow-up will be categorized as 'Initiated vaping' (outcome of interest), while those who respond 'No' at follow-up will be categorized as 'Did not initiate vaping' (reference group).

次要结局

  • Change in susceptibility to future vaping from baseline to 12-month follow-up(baseline and 12-month follow-up)
  • Change in number of students reporting past 30-day vaping from baseline to 12-month follow-up(baseline and 12-month follow-up)
  • Change in knowledge of vaping-related harms from baseline to 3- and 12-month follow-up(baseline, 3-month, and 12-month follow-up)

研究者

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

Adam Cole

Principal Investigator

University of Ontario Institute of Technology

研究点 (8)

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