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

NCT06018389 | Enrolling By Invitation

• 3 other identifiers: voresvalg_408332022-0367531 seqno. 3073ID: 155933
• Study Type: interventional
• Target: 3,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Prevention; High School; Alcohol; Substance Use; Adolescents; Motivational Interviewing; School Policies; Parents

Outcome Measures

Primary Outcomes (1)

• Past month high-intensity drinking

  Past month high-intensity drinking: peak drinks per drinking event, assessed with the Timeline FollowBack (TLFB) (count measure)

  From baseline to 12 months after baseline

Secondary Outcomes (6)

• 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 tobacco

  From baseline to 12 months after baseline

Study Arms (3)

Structural Only

EXPERIMENTAL

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.

Behavioral: Structural only

Structural+Group MI

EXPERIMENTAL

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.

Behavioral: Structural only; Behavioral: Structural+Group MI

Control

NO INTERVENTION

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.

Interventions

Structural only BEHAVIORAL

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 Only; Structural+Group MI

Structural+Group MI BEHAVIORAL

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.

Structural+Group MI

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under 15 years old

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Centre for Alcohol and Drug Research, Aarhus BSS, Aarhus University

Aarhus, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37875851 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Krisrtine Rømer Thomsen

  Centre for Alcohol and Drug Research, Aarhus BSS, Aarhus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: August 9, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)