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Enrolling by Invitation

NCT Number: NCT07132866

Randomized Controlled Trial of ADAPT

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.

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Key information

Conditions

Healthy Participants

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Alcohol and Drug Research, Department of Psychology and Behavioral Sciences, Aarhus BSS, Aarhus University, Aarhus, Denmark

Aarhus, 8000, Denmark

About this study

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.

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADAPT

Behavioral

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 outcomes

  1. Intentions to drink

    Time frame: 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 outcomes

  1. Past month use of alcohol

    Time frame: From baseline to 3 months post intervention

    Assessed with single items on past month use.

  2. Past month consequences of drinking

    Time frame: 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).

  3. Life satisfaction

    Time frame: 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.

  4. Psychological well-being

    Time frame: 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).

  5. Well-being in class

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Prevention of Alcohol Use and Promotion of Well-being Among Middle School Students: A Randomized Controlled Trial of ADAPT

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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