Prevention of Hazardous Use of Alcohol with Danish High School Students (Our Choice)
- Conditions
- Healthy Participants
- Interventions
- Behavioral: Structural onlyBehavioral: Structural+Group MI
- Registration Number
- NCT06018389
- Lead Sponsor
- University of Aarhus
- Brief Summary
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.
- Detailed Description
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:
1. Structural condition targeting school and parent levels via school policies for school-based social events and an information-based interactive parent meeting.
2. Structural condition combined with group-based Motivational Interviewing (group MI) which also targets the student level.
3. 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 3100
- 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
- Under 15 years old
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Structural Only Structural only The Structural Only condition consists of (1) school policies for school-based social events; and (2) an information-based interactive parent meeting. Interventions in this arm are targeting the school and parent level. Structural+Group MI Structural only The Structural+Group MI condition consists of the elements described in "Structural Only" and group MI. Interventions in this arm are targeting all three levels: school, parent and student level. Structural+Group MI Structural+Group MI The Structural+Group MI condition consists of the elements described in "Structural Only" and group MI. Interventions in this arm are targeting all three levels: school, parent and student level.
- Primary Outcome Measures
Name Time Method Past month high-intensity drinking 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)
- Secondary Outcome Measures
Name Time Method Past month alcohol-related consequences From baseline to 12 months after baseline Assessed by 21 items covering physical, social and mental issues related to hazardous use of alcohol, developed by the team for Danish youth based on single items from previous Danish surveys and the Rutgers Alcohol Problems Index e.g. black-outs, (emotional) hangovers), sexual contact that was later regretted, with yes/no response options (summed score: range 0-21) with higher scores indicating more negative consequences.
Well-being in class From baseline to 12 months after baseline Assessed by six items rated on a five-point scale from 'completely disagree' to 'completely agree' e.g., I feel accepted by the others in my class (summed score: range 0-30) with a score of 30 representing the best possible well-being in class.
Past month heavy episodic drinking events From baseline to 12 months after baseline Past month heavy episodic drinking events assessed by TLFB (count measure).
World Health Organization Five Well-being Index (WHO-5) From baseline to 12 months after baseline Psychological well-being, assessed by The World Health Organization Five Well-being Index (summed score: range 0-25) with a score of 25 representing the best possible quality of life.
Past month use of illegal substances From baseline to 12 months after baseline Measured by days using cannabis, cocaine, and other illegal drugs (count measure: range 0-30 days).
Past month use of tobacco From baseline to 12 months after baseline Measured by days using tobacco (count measure: range 0-30 days)
Trial Locations
- Locations (1)
Centre for Alcohol and Drug Research, Aarhus BSS, Aarhus University
🇩🇰Aarhus, Denmark