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

Официальное название

Prevention of Hazardous Use of Alcohol Among High School Students in Denmark: a Cluster Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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/choi

Первичные конечные точки

• Past month high-intensity drinking [Срок оценки: From baseline to 12 months after baseline]

Вторичные конечные точки (6)

• Past month alcohol-related consequences [Срок оценки: From baseline to 12 months after baseline]
• Past month heavy episodic drinking events [Срок оценки: From baseline to 12 months after baseline]
• Well-being in class [Срок оценки: From baseline to 12 months after baseline]
• World Health Organization Five Well-being Index (WHO-5) [Срок оценки: From baseline to 12 months after baseline]
• Past month use of tobacco [Срок оценки: From baseline to 12 months after baseline]
• Past month use of illegal substances [Срок оценки: From baseline to 12 months after baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Under 15 years old

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Дания · 1 центр

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

Публикации

• 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
• Vallentin-Holbech L, Dash GF, Feldstein Ewing SW, Nielsen AS, Tolstrup JS, Wellnitz KB, Ornbol E, Thomsen KR. Three-Arm Randomized Controlled Trial of Motivational Interviewing for Adolescent Drinking in Denmark. J Am Acad Child Adolesc Psychiatry. 2026 Jul 16:S0890-8567(26)00321-7. doi: 10.1016/j.jaac.2026.07.009. Online ahead of print. PMID 42462842

Идентификаторы

NCT: NCT06018389 · voresvalg_40833 · 2022-0367531 seqno. 3073 · ID: 155933

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗