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| ID | Type | Description | Link |
|---|---|---|---|
| ID: 160172 | Other Grant/Funding Number | TrygFonden, Denmark | |
| ID: BSS-2025-056-S2 | Registry Identifier | Research Ethics Comittee, Aarhus University, Denmark |
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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:
Additionally, acceptability and feasibility is examined.
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:
The following hypotheses are tested:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADAPT | Experimental | The ADAPT condition consist of the ADAPT intervention (group sessions with students, meeting with parents). |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Past month use of alcohol | Assessed with single items on past month use. | From baseline to 3 months post intervention |
| Past month consequences of drinking | 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). |
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Inclusion Criteria:
Exclusion Criteria:
- Not fulfilling inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kristine R Thomsen, PhD | Centre for Alcohol and Drug Research, Department of Psychology and Behavioral Sciences, Aarhus BSS, Aarhus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Alcohol and Drug Research, Department of Psychology and Behavioral Sciences, Aarhus BSS, Aarhus University, Aarhus, Denmark | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41204109 | Derived | 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. |
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After the conclusion of the study, data from the study will be made available by the Centre for Alcohol and Drug Research, Aarhus University, upon reasonable request, and within the limitations set by the Danish data protection legislation and regulation.
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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)
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| From baseline to 3 months post intervention |
| Life satisfaction | 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. | From baseline to 3 months post intervention |
| Psychological well-being | 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). | From baseline to 3 months post intervention |
| Well-being in class | 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. | From baseline to 3 months post intervention |