Condition category
Not Applicable
Date applied
07/04/2020
Date assigned
04/05/2020
Last edited
01/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Denmark is among the countries with the highest rate of substance abuse in Europe. Alcohol use is a major risk factor for a number of diseases and contributes as a significant factor to homicides, suicides, and motor vehicle fatalities. There is a strong relationship between early onset of drinking and later development of alcohol use disorders. Adolescents who begin drinking at a younger age also tend to have lower self-esteem, be less resistant to peer pressure and display anti-social features. Researchers have developed a Virtual Reality (VR) alcohol prevention programme “VR FestLab” – a gamified drama that unfolds at a teen house party, with a range of storylines, actioned and determined by the user. This study aims to test if a virtual social environment can help young people build their skills to make decisions and say “no” in situations where they may feel that they are subject to peer pressure in relation to alcohol and other drugs.

Who can participate?
Danish-speaking adolescents aged 15-18

What does the study involve?
The VR-based learning tool consists of a computer simulation of a three-dimensional environment that shows a typical party situation for young people. Participants are able to "steer" their own party through intuitive and realistic choices that can be carried out using special electronic equipment. Intended effects of the game “VR FestLab" are increased drinking refusal self-efficacy regards social pressures and a change of alcohol expectancies. The tool will be tested with 420 participants randomly allocated into a VR game play group and an active control group with another commercial game (e.g. Wii). The effect will be measured using a tested questionnaire that includes questions to assess a person's belief in his/her own ability to resist drinking alcohol in social situations and questions measuring the participants' expectations about the positive or negative outcomes of drinking alcohol. In addition, the researchers will investigate user satisfaction, game involvement and gaming experience through both questionnaires and individual interviews.

What are the possible benefits and risks of participating?
The possible benefits of participating in the study for the adolescents are that through this virtual social environment they can build their skills to make decisions and say “no” in situations where they may feel that they are subject to peer pressure in relation to alcohol and other drugs. There are not identified any possible risks of participating in this study. However, the study will involve collecting health behavior data regarding wellbeing, drinking and smoking behaviour which could be sensitive to disclosure for this age group. Further, the VR FestLab experience portraying a party situation may not be acceptable to adolescents with very strict religious beliefs, where any alcohol use is not permitted.

Where is the study run from?
University of Southern Denmark (Denmark)

When is the study starting and how long is it expected to run for?
June 2019 to July 2021

Who is funding the study?
TrygFonden (Denmark)

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

Trial website

https://www.sdu.dk/en/om_sdu/Institutter_centre/ist_sundhedstjenesteforsk/forskning/Sundhedsfremme/Forskningsprojekter/VRFestLab

Contact information

Type

Public

Primary contact

Prof Christiane Stock

ORCID ID

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

Contact details

Principal Investigator
Unit for Health Promotion Research
Department of Public Health
University of Southern Denmark
Esbjerg
6700
Denmark
+45 (0)65504210
cstock@health.sdu.dk

Type

Scientific

Additional contact

Prof Christiane Stock

ORCID ID

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

Contact details

Principal Investigator
Unit for Health Promotion Research
Department of Public Health
University of Southern Denmark
Esbjerg
6700
Denmark
+45 (0)65504210
cstock@health.sdu.dk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

TrygFonden ID 129372

Study information

Scientific title

Does a virtual reality-based game improve alcohol resistance skills among adolescents? A cluster randomised controlled trial

Acronym

VR FestLab

Study hypothesis

The main hypothesis is that adolescents who experience “VR FestLab" score higher in drinking refusal self-efficacy (DRSQ) and drug refusal skill scales compared to those in an active control group.
The secondary aim is to test the effects of game to encourage adolescents towards more responsible behaviour in party situations. The hypothesis is that the “VR FestLab" increases awareness of social pressures and creates more realistic outcome expectations and positive role-models for staying in control.

Ethics approval

Approved 20/03/2020, Research Ethics Committee of the University of Southern Denmark (University of Southern Denmark, cc: Nadine Kollmeyer, SDU Research & Innovation Organisation, Cortex Park 26, DK – 5230 Odense M, Denmark; +45 (0)6550 3578 / 9350 7483; nadko@sdu.dk), ref: 20/5348

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Intervention

Current interventions as of 01/10/2020:
The trial is conducted in grades 9 and 10 of public and boarding schools in the region of Southern Denmark. Randomization will be performed by a statistician by the use of the randomization function in SAS.

Intervention schools:
All classes receive the same intervention consisting of a session where each student will try the virtual reality FestLab game, followed by a group session where the experiences will be discussed.

Control schools:
All classes receive the same intervention consisting of a session where each student will try another VR game (Oculus Quest – First Steps). All classes are offered to try the VR FestLab game after participating in the follow-up survey as an incentive to participate.

The total duration of the intervention itself is approximately 45 minutes.


Previous interventions:
The trial is conducted in grades 9 and 10 of public and boarding schools in the region of Southern Denmark. Randomization will be performed by a statistician by the use of the randomization function in SAS.

Intervention schools:
All classes receive the same intervention consisting of a session where each student will try the virtual reality FestLab game, followed by a group session where the experiences will be discussed.

Control schools:
All classes receive the same intervention consisting of a session where each student will try another VR game (Merry Snowballs). All classes are offered to try the VR FestLab game after participating in the follow-up survey as an incentive to participate.

The total duration of the intervention itself is approximately 45 minutes.

6-8 focus group interviews will be conducted with pupils in the intervention group regards their experiences with VR FestLab. Focus group interviews will be conducted according to individual arrangements with the schools.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

1. Resistance towards peer pressure to drink measured by the Social Pressure subscale of the DRSEQ-R at baseline, at first follow up (immediately after the intervention), and second follow up (6 weeks follow-up)
2. Drug refusal skills measured using the Brief Assessment Tool for the Life Skills Training Drug-Abuse at baseline, first follow up (immediately after the intervention), and second follow up (6 weeks follow-up)

Secondary outcome measures

All secondary outcome measures (except gameplay experiences) are measured by the baseline survey, first follow up (immediately after the intervention), and second follow up (6 weeks follow-up). Gameplay experiences are measured immediately after the intervention only.

1. Knowledge of blood-alcohol concentration (BAC) measured using questions developed by the research team at baseline, first follow up, and second follow up
2. Communication skills measured using the items concerning knowledge in the Alcohol Misuse Prevention questionnaire at baseline, first follow up, and second follow up
3. Positive role-models measured using questions developed by the research team with inspiration from the Regan Attitudes toward Non-Drinkers Scale (RANDS) at baseline, first follow up, and second follow up
4. Social support willingness measured using questions developed by the research team at baseline, first follow up, and second follow up
5. Outcome expectations measured using Danish “Ungeprofil” [Youth profile] at baseline, first follow up, and second follow up
6. Awareness of social pressures measured using one item of the Susceptibility to Peer Pressure index at baseline, first follow up, and second follow up
7. Gameplay experience (level of engagement, enjoyment and emotional reactions) measured by a scale developed by the research team as well as with the User Experience Questionnaire (UEQ-S) immediately after the intervention (first follow up) only

6-8 focus group interviews will be conducted with pupils in the intervention group regards their experiences with VR FestLab. Focus group interviews will be conducted according to individual arrangements with the schools.

Overall trial start date

01/06/2019

Overall trial end date

31/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Public primary/elementary schools in the Region of Southern Denmark
2. Students aged 15 – 18
3. Males/females/diverse

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

10 clusters (schools) with 420 participants (pupils)

Participant exclusion criteria

1. Individual students with insufficient knowledge of Danish to understand typical everyday conversations
2. Individual students with special educational needs in mainstream classrooms

Recruitment start date

01/06/2020

Recruitment end date

01/02/2021

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 (0)45 26 08 00
info@trygfonden.dk

Sponsor type

Charity

Website

http://www.trygfonden.dk/

Funders

Funder type

Charity

Funder name

TrygFonden

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. An article about the study protocol will be published in October 2020
2. Intervention design article
3. Intervention effect

IPD sharing statement
For access to the datasets please contact the principal investigator Associate professor Christiane Stock (cstock@health.sdu.dk). The type of data which is available upon request is data from the pre, post and follow-up survey. Data will, after full anonymization, be available after the project is finished, and the effect paper is published. Access criteria for access to the data are that the data can only be used for analysis which is out of scope for the present study. All researchers or students in higher education are eligible for access to the data. Accessed data will be available for statistical analysis and will be accessed by being granted access to a cloud where data is stored. At the beginning of the questionnaire the researchers have specified that all information the participants provide in connection with the questionnaire will be treated confidentially and anonymously. An individual anonymous code will be generated based on background information such as first letter in mother’s name, school and month of birth. After the generation of the code these variables will be deleted. The pseudoanonymized data will later be fully anonymized.

Intention to publish date

30/10/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/10/2020: The interventions were updated. 03/09/2020: The following changes were made to the trial record: 1. The recruitment end date was changed from 01/09/2020 to 01/02/2021. 2. The intention to publish date was changed from 30/06/2021 to 30/10/2021. 29/04/2020: Trial's existence confirmed by Research Ethics Committee of the University of Southern Denmark.