Prevention of Alcohol Use and Promotion of Well-being Among Middle School Students: A Randomized Controlled Trial of ADAPT
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Intentions to drink
研究概览
简要总结
This trial examines the effectiveness of a novel neurodevelopmentally informed intervention - Adolescent Developmentally-Appropriate health Promotion Therapy (ADAPT) - on preventing alcohol use and promoting well-being among students in middle school in a heavy adolescent alcohol use region (Denmark). Using a 2-condition cluster-randomized controlled trial of students in 8th grade (ages 13-15), the following hypotheses are tested:
- Compared to adolescents in the Delayed Treatment Condition (DTC), ADAPT adolescents will show significant reductions in intentions to drink (primary outcome) from baseline to 3 months post intervention.
- Compared to adolescents in the DTC, ADAPT adolescents will show significant reductions in alcohol use and alcohol-related consequences, and significant increases in well-being and life satisfaction (secondary outcomes) from baseline to 3 months.
Additionally, acceptability and feasibility is examined.
详细描述
The main aim of this trial is to examine the effectiveness of a novel neurodevelopmentally informed intervention - Adolescent Developmentally-Appropriate health Promotion Therapy (ADAPT) - on preventing alcohol use and promoting well-being among students in middle school in a heavy adolescent alcohol use region (Denmark). Furthermore, we aim to examine ADAPT's feasibility and acceptability with students in middle school, their parents, and with staff (e.g., teachers and principals), to inform and guide next step, larger scale randomized controlled trials.
The study employs a 2-condition cluster-randomized controlled design in 8th grade students (ages 13-15), with the following conditions:
- ADAPT: ADAPT intervention (consisting of three group sessions with students and one meeting with parents per school class) will be conducted by study staff immediately after baseline.
- Delayed Treatment: ADAPT is offered to interested schools after the 3-month follow-up survey is completed.
The following hypotheses are tested:
- Compared to adolescents in the DTC, ADAPT adolescents will show significant reductions in intentions to drink (primary outcome) from baseline to 3 months post intervention.
- Compared to adolescents in the DTC, ADAPT adolescents will show significant reductions in alcohol use and alcohol-related consequences, and significant increases in well-being and life satisfaction (secondary outcomes) from baseline to 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Students starting 8th grade in August 2025 in one of the participating public middle schools
- •Understand and speak Danish
- •Able to give informed active consent with informed passive consent from parents/guardians
排除标准
- •Not fulfilling inclusion criteria
研究组 & 干预措施
ADAPT
The ADAPT condition consist of the ADAPT intervention (group sessions with students, meeting with parents).
干预措施: ADAPT (Behavioral)
Delayed Treatment Condition (DTC)
The control condition is a DTC. All adolescents in the DTC will receive assessments on the same timeline as ADAPT adolescents, but will not receive the intervention. Following the final 3-months follow-up survey, ADAPT will be offered to DTC students and their parents.
结局指标
主要结局
Intentions to drink
时间窗: From baseline to 3 months post intervention
Assessed by single items assessing intention to drink at least one unit of alcohol and intention to get drunk (dichotomized).
次要结局
- Past month use of alcohol(From baseline to 3 months post intervention)
- Past month consequences of drinking(From baseline to 3 months post intervention)
- Life satisfaction(From baseline to 3 months post intervention)
- Psychological well-being(From baseline to 3 months post intervention)
- Well-being in class(From baseline to 3 months post intervention)