Randomized Controlled Trial of ADAPT

NCT07132866 | Enrolling By Invitation

• 3 other identifiers: ADAPT_160172ID: 160172ID: BSS-2025-056-S2
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Healthy Participants

Keywords

Prevention intervention; Neurodevelopmentally informed; Adolescents; Middle school; Alcohol; Parents; Prosocial

Outcome Measures

Primary Outcomes (1)

• Intentions to drink

  Assessed by single items assessing intention to drink at least one unit of alcohol and intention to get drunk (dichotomized).

  From baseline to 3 months post intervention

Secondary Outcomes (5)

• 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

Study Arms (2)

ADAPT

EXPERIMENTAL

The ADAPT condition consist of the ADAPT intervention (group sessions with students, meeting with parents).

Behavioral: ADAPT

Delayed Treatment Condition (DTC)

NO INTERVENTION

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.

Interventions

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).

ADAPT

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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 DERIVED

Study Officials

• Kristine R Thomsen, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study employs a 2-condition cluster randomized controlled trial design with two conditions: 1) ADAPT intervention, 2) Delayed Treatment (ADAPT intervention offered after the last follow-up)

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2029
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)