Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
50-50110-98-208, NL593, NTR649
Study information
Scientific title
Reduction of alcohol use by young adolescents: a randomized trial with four conditions
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
15/04/2006
Overall trial end date
28/02/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adolescents in the first grade of secondary school
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
5400
Total final enrolment
3490
Participant exclusion criteria
Adolescents who do not attend school
Recruitment start date
15/04/2006
Recruitment end date
28/02/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Trimbos-Institute - Netherlands Institute of Mental Health and Addiction
Utrecht
3500 AS
Netherlands
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in https://pubmed.ncbi.nlm.nih.gov/21265908/ (added 08/01/2021)