Clinical trial NCT06018389: Prevention of Hazardous Use of Alcohol with Danish High School Students (Our Choice)
Official title: Prevention of Hazardous Use of Alcohol Among High School Students in Denmark: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy Participants
Keywords: Prevention
High School
Alcohol
Substance Use
Adolescents
Motivational Interviewing
School Policies
Parents
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 3100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study employs a parallel group cluster randomized controlled trial design with three conditions: 1) structural condition targeting school and parent levels, 2) structural condition combined with group MI which also targets the student level, and 3) assessment-only control condition (interventions offered after the last follow-up survey).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Past month high-intensity drinking
timeFrame: From baseline to 12 months after baseline
Secondary outcomes:
measure: Past month alcohol-related consequences
timeFrame: From baseline to 12 months after baseline
measure: Past month heavy episodic drinking events
timeFrame: From baseline to 12 months after baseline
measure: Well-being in class
timeFrame: From baseline to 12 months after baseline
measure: World Health Organization Five Well-being Index (WHO-5)
timeFrame: From baseline to 12 months after baseline
measure: Past month use of tobacco
timeFrame: From baseline to 12 months after baseline
measure: Past month use of illegal substances
timeFrame: From baseline to 12 months after baseline
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Centre for Alcohol and Drug Research, Aarhus BSS, Aarhus University
Study officials:
affiliation: Centre for Alcohol and Drug Research, Aarhus BSS, Aarhus University
name: Krisrtine Rømer Thomsen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romer Thomsen K, Vallentin-Holbech L, Xylander S, Wellnitz KB, Tolstrup J, Nielsen AS, Ewing SWF. Prevention of hazardous use of alcohol among high school students: a study protocol for the randomized controlled trial 'Our choice'. BMC Public Health. 2023 Oct 24;23(1):2079. doi: 10.1186/s12889-023-16976-y.