Prevention of Hazardous Use of Alcohol with Danish High School Students (Our Choice)
NCT ID: NCT06018389
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
3100 participants
INTERVENTIONAL
2023-08-09
2027-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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 only
A shared list of school policies for or related to, school-based social events at school premises. The policy initiatives include (but are not limited to): increasing the number of social events without alcohol; promoting non-alcoholic beverages at parties; working with student associations regarding their roles and responsibilities; encouraging parental involvement at school events and disseminating the schools' alcohol policy among students and parents. The school principal and management will be responsible for the implementation and enforcement of the policies.
The Information-based interactive parent meetings will be 45 minutes and will take place at the schools. Parents will be offered concrete, research-informed advice about how they can reduce risk of hazardous substance use and promote well-being among their adolescents. Following a 15-minute presentation, the group leader facilitates a discussion and exchange of experience between parents.
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.
Structural only
A shared list of school policies for or related to, school-based social events at school premises. The policy initiatives include (but are not limited to): increasing the number of social events without alcohol; promoting non-alcoholic beverages at parties; working with student associations regarding their roles and responsibilities; encouraging parental involvement at school events and disseminating the schools' alcohol policy among students and parents. The school principal and management will be responsible for the implementation and enforcement of the policies.
The Information-based interactive parent meetings will be 45 minutes and will take place at the schools. Parents will be offered concrete, research-informed advice about how they can reduce risk of hazardous substance use and promote well-being among their adolescents. Following a 15-minute presentation, the group leader facilitates a discussion and exchange of experience between parents.
Structural+Group MI
Within school classes, students are divided into groups of 5-8 students and each group will be assigned a group leader from the research team. The group-based Motivational Interviewing (group MI) is manualized and consists of two one-hour group sessions administered over two consecutive weeks. The first session is focused on "Tell your story", "Gains from not drinking", and "Social norms." In the second session, the focus is on "Personal values", "Linking values with behavior" and "Planning/choices regarding alcohol". Both group MI sessions will take place at the schools during the school day.
Control
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.
No interventions assigned to this group
Interventions
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Structural only
A shared list of school policies for or related to, school-based social events at school premises. The policy initiatives include (but are not limited to): increasing the number of social events without alcohol; promoting non-alcoholic beverages at parties; working with student associations regarding their roles and responsibilities; encouraging parental involvement at school events and disseminating the schools' alcohol policy among students and parents. The school principal and management will be responsible for the implementation and enforcement of the policies.
The Information-based interactive parent meetings will be 45 minutes and will take place at the schools. Parents will be offered concrete, research-informed advice about how they can reduce risk of hazardous substance use and promote well-being among their adolescents. Following a 15-minute presentation, the group leader facilitates a discussion and exchange of experience between parents.
Structural+Group MI
Within school classes, students are divided into groups of 5-8 students and each group will be assigned a group leader from the research team. The group-based Motivational Interviewing (group MI) is manualized and consists of two one-hour group sessions administered over two consecutive weeks. The first session is focused on "Tell your story", "Gains from not drinking", and "Social norms." In the second session, the focus is on "Personal values", "Linking values with behavior" and "Planning/choices regarding alcohol". Both group MI sessions will take place at the schools during the school day.
Eligibility Criteria
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Inclusion Criteria
* 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
15 Years
ALL
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Krisrtine Rømer Thomsen
Role: PRINCIPAL_INVESTIGATOR
Centre for Alcohol and Drug Research, Aarhus BSS, Aarhus University
Locations
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Centre for Alcohol and Drug Research, Aarhus BSS, Aarhus University
Aarhus, , Denmark
Countries
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References
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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.
Other Identifiers
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2022-0367531 seqno. 3073
Identifier Type: OTHER
Identifier Source: secondary_id
ID: 155933
Identifier Type: OTHER
Identifier Source: secondary_id
voresvalg_40833
Identifier Type: -
Identifier Source: org_study_id