Randomized Controlled Trial of ADAPT

NCT ID: NCT07132866

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2029-02-28

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).

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

ADAPT

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

Group Type: EXPERIMENTAL

ADAPT

Intervention Type: 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).

Delayed Treatment Condition (DTC)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristine R Thomsen, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

ID: 160172

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ID: BSS-2025-056-S2

Identifier Type: REGISTRY

Identifier Source: secondary_id

ADAPT_160172

Identifier Type: -

Identifier Source: org_study_id