Reduction of alcohol use by young adolescents: a randomized trial with four conditions
| ISRCTN | ISRCTN31724721 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31724721 |
| Secondary identifying numbers | 50-50110-98-208, NL593, NTR649 |
- Submission date
- 07/06/2006
- Registration date
- 07/06/2006
- Last edited
- 08/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J. Verdurmen
Scientific
Scientific
Trimbos-Institute - Netherlands Institute of Mental Health and Addiction
P.O. Box 725
Utrecht
3500 AS
Netherlands
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Reduction of alcohol use by young adolescents: a randomized trial with four conditions |
| Study objectives | The implementation of the interventions will reduce alcohol use by adolescents under the age of 16, measured by the percentage of binge drinking, the weekly number of drinks and the percentage of adolescents who drink on a weekly basis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Alcohol abuse or addiction |
| Intervention | The objective of the present study is to determine the effectiveness of two interventions for reducing alcohol use by young adolescents: the renewed alcohol module, developed within the scope of the healthy school and drugs program, based on elements proven effective in the past in previous modules, and a new parent intervention that focuses primarily on influencing the way parents raise their children with respect to alcohol consumption. The renewed alcohol module consists of four lessons. The parent intervention is introduced during a parent evening at the school. Both interventions will be held in the first year of secondary education. Schools will be randomly assigned to one of the following four conditions: 1. Regular curriculum 2. Renewed healthy school and drugs alcohol module 3. Parent intervention (PI) 4. Combination of 2 and 3 above |
| Intervention type | Other |
| Primary outcome measure | Over a course of three years, the effectiveness of two interventions for reducing alcohol use by adolescents under the age of 16 is assessed. In particular, we examine the effectiveness of each of the interventions offered separately and simultaneously. The interventions are targeted at the reduction of alcohol consumption among young adolescents. These objectives will be concretized with the following attainment targets: 1. Reduce the percentage of binge drinking (>5 drinks) by at least 10% 2. Reduce the weekly number of drinks from 10 to 6 drinks 3. Reduce the percentage of adolescents who drink on a weekly basis by 10% The parent intervention will take place in October 2006, booster sessions at the beginning of each successive school year in 2007 and 2008. The alcohol module will be run from March to April of the first grade in secondary education in all participating schools in 2007. Measurements will take place before the first intervention, T0 August to September 2006, and at the beginning of each successive school year; T1 October to November 2007, T2 October to November 2008, T3 October to November 2009. Students will answer a digital questionnaire in their classroom. Parents will be sent a questionnaire by post. |
| Secondary outcome measures | We will examine whether the effectiveness of the intervention is dependent upon the particular child, parent or school characteristics (moderator-effects) and whether the effectiveness is mediated by a particular child, parent or school characteristics. In addition, it will be analysed whether the interventions have a simultaneous effect on the reduction of externalising problem behaviour. |
| Overall study start date | 15/04/2006 |
| Completion date | 28/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 5400 |
| Total final enrolment | 3490 |
| Key inclusion criteria | Adolescents in the first grade of secondary school |
| Key exclusion criteria | Adolescents who do not attend school |
| Date of first enrolment | 15/04/2006 |
| Date of final enrolment | 28/02/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Trimbos-Institute - Netherlands Institute of Mental Health and Addiction
Utrecht
3500 AS
Netherlands
3500 AS
Netherlands
Sponsor information
University Medical Center Utrecht (UMCU) (The Netherlands)
University/education
University/education
P.O. Box 85500
Utrecht
3508 GA
Netherlands
"ROR" |
https://ror.org/0575yy874 |
|---|
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development (ZonMw)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2009 | 08/01/2021 | Yes | No |
Editorial Notes
08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
