Prevention of Hazardous Use of Alcohol with Danish High School Students (Our Choice)

University of Aarhus

Status: Invitation-only

Conditions: Healthy Participants

Treatments: Behavioral: Structural+Group MI; Behavioral: Structural only

Study type: Interventional

Funder types: Other

Identifiers

NCT06018389

2022-0367531 seqno. 3073 (Other Identifier)

ID: 155933 (Other Identifier)

voresvalg_40833

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,100 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Under 15 years old

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,100 participants in 3 patient groups

Structural Only

Experimental group

Description:

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.

Treatment:

Behavioral: Structural only

Structural+Group MI

Experimental group

Description:

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.

Treatment:

Behavioral: Structural only

Behavioral: Structural+Group MI

Control

No Intervention group

Description:

The Control condition is an assessment-only condition. During the period under study, it includes the same assessments (surveys) as the other two conditions. After the last follow-up (August 2024), control schools can opt-in to receive any of the intervention programs.