Randomized Controlled Trial of ADAPT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ADAPT.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: from 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prevention of Alcohol Use and Promotion of Well-being Among Middle School Students: A Randomized Controlled Trial of ADAPT
Overview
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).
Interventions
- Behavioral ADAPT
The ADAPT intervention consists of three group sessions (of 75-90 min), with 6-8 8th grade students in each group, administered over three consecutive weeks, plus one interactive parent component (of 45 min) administered during the three weeks (separate from the student sessions).
Primary outcome measures
- Intentions to drink [Time frame: From baseline to 3 months post intervention]
Secondary outcome measures (5)
- Past month use of alcohol [Time frame: From baseline to 3 months post intervention]
- Past month consequences of drinking [Time frame: From baseline to 3 months post intervention]
- Life satisfaction [Time frame: From baseline to 3 months post intervention]
- Psychological well-being [Time frame: From baseline to 3 months post intervention]
- Well-being in class [Time frame: From baseline to 3 months post intervention]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
\- Not fulfilling inclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Centre for Alcohol and Drug Research, Department of Psychology and Behavioral Sciences, Aa — Aarhus
Publications
- Romer Thomsen K, Hareskov N, Caspersen CK, Lauenborg AM, Bergmann MG, Ornbol E, Wellnitz KB, Feldstein Ewing SW. Prevention of alcohol use and promotion of well-being among middle school students: a study protocol for a randomized controlled trial of ADAPT. BMC Public Health. 2025 Nov 7;25(1):3840. doi: 10.1186/s12889-025-25037-5. PMID 41204109
Identifiers
NCT: NCT07132866 · ADAPT_160172 · ID: 160172 · ID: BSS-2025-056-S2