Condition category
Mental and Behavioural Disorders
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
07/06/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J. Verdurmen

ORCID ID

Contact details

Trimbos-Institute - Netherlands Institute of Mental Health and Addiction
P.O. Box 725
Utrecht
3500 AS
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

50-50110-98-208

Study information

Scientific title

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 measures

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

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

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

Sponsor information

Organisation

University Medical Center Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes