Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-02 @ 10:39 AM
Study NCT ID:
NCT07132866
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-20
First Post:
2025-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of ADAPT
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Prevention of Alcohol Use and Promotion of Well-being Among Middle School Students: A Randomized Controlled Trial of ADAPT
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: