Condition category
Mental and Behavioural Disorders
Date applied
28/01/2016
Date assigned
17/02/2016
Last edited
12/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The use of alcohol and other drugs (AOD) among adolescents in Denmark is one of the highest in Europe. Some 34% of Danish pupils aged 15-16 years have already experienced being drunk while an average in Europe for this age group is 17%. Similarly, the percentage of binge drinking i.e. who have consumed five or more drinks at one drinking session, in this age group is high with 38% and 26% for boys and girls, respectively. Improvements in alcohol behaviour have been seen during past few years, but, as the numbers reveal ,not enough to be comparable to other European countries. Long-term, there is a risk that harmful drinking could develop in adulthood, along with alcohol dependency and alcohol related diseases later in life. In other countries social norm marketing has been shown to be an good method of reducing the amount of alcohol young people drink. Social norms are “perception and beliefs of what is normal behaviour in the people close to us” and they are found to be a key factor for modifying drug use. Adolescents in particular tend to overestimate the amount of drugs that other people in their peer group take, leading them to take more drugs themselves. Individuals may overestimate the frequency and quantity of alcohol use (descriptive norms) as well as how acceptable peers feel heavy drinking to be (injunctive norms). Based on social comparison theory individuals are then motivated to match their own alcohol use to this incorrect perception. On the basis of previous studies showing promising results the current study ‘The GOOD life’ has been developed. The aim is to determine the effectiveness of a basic social norm intervention (programme) in preventing binge drinking and social misperceptions among adolescents 14-16 years old in the Region of Southern Denmark.

Who can participate?
The trial will be run in the region of Southern Denmark. All pupils in grade 8 or 9 can participate.

What does the study involve?
The schools who confirm participation are randomly allocated to one of two groups. Schools in the intervention group receive a one hour feedback session on the theory of social norms and the difference between true and perceived alcohol consumption amongst pupils. Each school is also given 4-5 posters with various messages selected specifically for that school which are then put up for the duration of the study period. There is also a web-based app where pupils can test their own social misunderstandings. Schools in the control group carry on as usual during the study period but do receive the GOOD life programme after it is complete. All pupils (in both groups of schools) fill out surveys on how much alcohol they drink, whether they have smoked tobacco or taken drugs and their perceptions on how much their peers drink, smoke or take drugs at the beginning of the study and then again after 4 months.

What are the possible benefits and risks of participating?
The potential benefits are for pupils are correcting misperceptions of peer alcohol and other drug consumption and reduced engagement in risk-behaviour. Potential risks can be feelings of guilt or discomfort related to own alcohol and other drug use.

Where is the study run from?
University of Southern Denmark, Unit for Health Promotion Research

When is study starting and how long is it expected to run for?
January 2014 to June 2017

Who is funding the study?
1. TrygFonden, Denmark
2. University of Southern Denmark

Who is the main contact?
Dr Christiane Stock
cstock@health.sdu.dk

Trial website

http://sdu.dk/en/Om_SDU/Institutter_centre/Ist_sundhedstjenesteforsk/Forskning/Forskningsenheder/Sundhedsfremme/Forskningsprojekter/detgodeliv

Contact information

Type

Scientific

Primary contact

Dr Christiane Stock

ORCID ID

http://orcid.org/0000-0001-9379-3844

Contact details

University of Southern Denmark
Niels Bohrs Vej 9-10
Esbjerg
6700
Denmark
++45 6550 2101
cstock@health.sdu.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

S-20140185

Study information

Scientific title

Social norms intervention to prevent drug use and its harmful consequences among Danish adolescents: Det gode liv mellem de unge

Acronym

TheGOODlife

Study hypothesis

The social norm intervention results in a 20% decrease in binge drinking (5 or more drinks per one occasion) among pupils from intervention schools compared to control schools

Ethics approval

De Videnskabsetiske Komitéer for Region Syddanmark (The Regional Committees on Health Research Ethics for Southern Denmark), approved December 15, 2014, S-20140185

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Condition

The use of alcohol and other drugs (AOD) among young people in Denmark.

Intervention

The trial is conducted in grades 8 and 9 of public schools in the region of Southern Denmark.

Intervention schools:
All schools receive the same intervention consisting of three intervention components:
Normative feedback is given through social norms messages for each school. They are phrased to challenge potential overestimations of peer behaviour and attitude towards alcohol use. The messages are used throughout the three main components of the “The GOOD life” programme.
1. A one-hour feedback session: Schools will receive a class-based feedback session on the theory of social norms and the discrepancy between perceived and true consumption of alcohol. The session is based on interaction and high amount of inclusion of pupils e.g. through a web-based poll, which displays what the class collectively assume to be the truth where after the true data from the baseline data collection are presented.
2. Posters: Each school will receive 4-5 posters with various selected messages specific for the school. Teachers are asked to hang them up for the remaining period of the intervention.
3. Web-app: A web-based element is included, where pupils by using laptops or smartphones can test their social misunderstandings. The app function as the web-poll, but on an individual basis.

Control schools:
Do not receive any social norms intervention during the trial period. They receive the feedback sessions and posters for their school after participating in the follow-up survey as incentive to participate.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Binge drinking (more than 5 units per one occasion) during the last 30 days measured by baseline survey and follow-up survey after 4 months

Secondary outcome measures

1. Smoking in the last 30 days
2. Marihuana use in the last 30 days
3. Perceived alcohol use of peers
4. Perceived smoking of peers
5. Perceived marihuana use of peers
6. Number of alcohol related harms

All secondary outcomes measured by baseline survey and follow-up survey after 4 months.

Overall trial start date

01/01/2014

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Public schools in the Region of Southern Denmark
2. Pupils in grades 8 or 9

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

26 clusters (schools) with 70 participants (pupils)

Participant exclusion criteria

Private schools

Recruitment start date

01/01/2015

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Denmark

Trial participating centre

University of Southern Denmark
Niels Bohrs Vej 9-10
Esbjerg
6700
Denmark

Sponsor information

Organisation

TrygFonden

Sponsor details

Hummeltoftevej 49
Virum
2830
Denmark
++45 26 08 00
info@trygfonden.dk

Sponsor type

Charity

Website

https://www.trygfonden.dk/english

Funders

Funder type

Research organisation

Funder name

TrygFonden

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Syddansk Universitet

Alternative name(s)

University of Southern Denmark, SDU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Denmark

Results and Publications

Publication and dissemination plan

1. Intervention design article July 2016
2. Baseline findings August 2016
3. Intervention effect article February 2017

Intention to publish date

01/03/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes