Prevention of Hazardous Use of Alcohol Among High School Students in Denmark: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 3,100
- 试验地点
- 1
- 主要终点
- Past month high-intensity drinking
研究概览
简要总结
The trial 'Our Choice' examines the effect of two prevention interventions targeting school, parent, and student levels at Danish high schools. The interventions aim to reduce hazardous use of alcohol and related health outcomes among first-year students in Denmark (ages 15-18). The investigators hypothesizes that a structural intervention (school and parent levels) reduces hazardous alcohol use and related health outcomes compared to an assessment-only control group 12 months post baseline; and that adding group-based Motivational Interviewing (group MI) yields further improvements. Additionally, factors related to the implementation of the interventions are examined.
详细描述
The main aim of the 'Our Choice' cluster randomized controlled multisite trial is to test the efficacy of interventions aimed at reducing hazardous use of alcohol and related health outcomes among first-year students (15-18 years) in high schools in Denmark. Furthermore, the aim is to examine feasibility and acceptability of the interventions with Danish students in high school, as well as with staff (e.g., teachers and principals) to inform future implementation studies.
The study employs a parallel group cluster randomized controlled trial design with three conditions:
- Structural condition targeting school and parent levels via school policies for school-based social events and an information-based interactive parent meeting.
- Structural condition combined with group-based Motivational Interviewing (group MI) which also targets the student level.
- Assessment-only control condition with the same assessments as the other two conditions and with interventions offered after the last follow-up survey.
The study hypothesizes that students in the structural condition (school and parent levels) reduce hazardous alcohol use and related health outcomes compared to students in the assessment-only control condition 12 months post baseline; and that adding group MI yields further improvements.
A participatory approach is used to adapt and develop interventions. Sixteen high schools in Denmark and N=3100 first-year students enrolled in high school in August 2023 will be recruited. Data will be collected via online questionnaires pre-interventions (baseline), 2, 6, 9 and 12 months post baseline. The primary outcome will be analyzed with generalized linear mixed models. Feasibility and acceptability will be assessed via surveys (students) and interviews (high school staff) to inform future implementation.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students starting high school in one of the 16 participating high schools in August 2023
- •Minimum 15 years old
- •Understand and speak Danish
- •Able to give independent informed consent
- •Staff (school principals, teachers, or administrative employees) from one of the 16 participating high schools
排除标准
- •Under 15 years old
结局指标
主要结局
Past month high-intensity drinking
时间窗: From baseline to 12 months after baseline
Past month high-intensity drinking: peak drinks per drinking event, assessed with the Timeline FollowBack (TLFB) (count measure)
次要结局
- Past month alcohol-related consequences(From baseline to 12 months after baseline)
- Past month heavy episodic drinking events(From baseline to 12 months after baseline)
- Well-being in class(From baseline to 12 months after baseline)
- World Health Organization Five Well-being Index (WHO-5)(From baseline to 12 months after baseline)
- Past month use of illegal substances(From baseline to 12 months after baseline)
- Past month use of tobacco(From baseline to 12 months after baseline)