Randomized Controlled Trial of ADAPT
- Conditions
- Healthy Participants
- Registration Number
- NCT07132866
- Lead Sponsor
- University of Aarhus
- Brief Summary
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:
1. 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.
2. 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.
- Detailed Description
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:
1. 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.
2. Delayed Treatment: ADAPT is offered to interested schools after the 3-month follow-up survey is completed.
The following hypotheses are tested:
1. 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.
2. 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.
All participants will complete an online baseline survey pre-intervention and online follow-ups at 1- and 3-months. Due to the large target N (N=1000), we will randomize students (and schools) in two blocks. The primary and secondary outcomes will be analyzed using generalized estimation equations (GEE) to account for the nested data structure: repeated measures, nested within students, nested within groups, nested within school classes, nested within schools. Feasibility of ADAPT will be measured quantitatively via student enrollment and attendance in ADAPT groups sessions, and parent attendance in the parent meeting. Acceptability of ADAPT will be measured via surveys (students, parents) and interviews (school staff).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1000
- 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
- Not fulfilling inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Intentions to drink 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).
- Secondary Outcome Measures
Name Time Method Past month use of alcohol From baseline to 3 months post intervention Assessed with single items on past month use.
Past month consequences of drinking From baseline to 3 months post intervention Assessed by 14 items covering physical, social and mental issues related to hazardous use of alcohol, developed by the team for Danish adolescents based on previous Danish surveys and the Rutgers Alcohol Problems Index. Example items include blackouts, (emotional) hangovers, intimate contact that was later regretted, with yes/no response options (summed score).
Life satisfaction From baseline to 3 months post intervention Assessed with the Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS), which measures perceived life satisfaction across five life domains (family life, friends, school, self, and living conditions), with a 7-point scale ranging from 'terrible' to 'delighted'. The mean of the sum of the 5 items represents the total life satisfaction score.
Psychological well-being From baseline to 3 months post intervention Assessed with the World Health Organization Five Well-being Index (WHO-5). The Index includes five positively phrased items, and participants rate how well each statement applies to them (past two weeks) using a 6-point scale, ranging from 'None of the time' to 'All of the time' (summed score: range 0-25) with a score of 25 representing the best possible quality of life).
Well-being in class From baseline to 3 months post intervention Assessed by six items rated on a five-point scale from 'completely disagree' to 'completely agree' e.g., I feel accepted by the others in my class (summed score: range 0-30) with a score of 30 representing the best possible well-being in class.
Trial Locations
- Locations (1)
Centre for Alcohol and Drug Research, Department of Psychology and Behavioral Sciences, Aarhus BSS, Aarhus University, Aarhus, Denmark
🇩🇰Aarhus, Denmark
Centre for Alcohol and Drug Research, Department of Psychology and Behavioral Sciences, Aarhus BSS, Aarhus University, Aarhus, Denmark🇩🇰Aarhus, Denmark