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Enrolling by invitation Not applicable

Randomized Controlled Trial of ADAPT

NCT07132866 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2025-08-18
Last updated
2025-08-20

Condition(s) studied

Healthy Participants

Investigational drug(s) / intervention(s)

ADAPT

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).

Study 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.

Eligibility

Sex
ALL
Min age
13 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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).

Trial sites (1)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07132866 on ClinicalTrials.gov ↗ ← All trials in Denmark