Does the game VR FestLab improve alcohol resistance skills among adolescents?

ISRCTN	ISRCTN11768445
DOI	https://doi.org/10.1186/ISRCTN11768445
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	TrygFonden ID 129372
Sponsor	TrygFonden
Funder	TrygFonden

Submission date: 07/04/2020
Registration date: 04/05/2020
Last edited: 14/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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 May 2021

Who is funding the study?
TrygFonden (Denmark)

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

Contact information

Prof Christiane Stock
Public

Principal Investigator
Unit for Health Promotion Research
Department of Public Health
University of Southern Denmark
Esbjerg
6700
Denmark

ORCID ID	0000-0001-9379-3844
Phone	+45 (0)65504210
Email	cstock@health.sdu.dk

Prof Christiane Stock
Scientific

Principal Investigator
Unit for Health Promotion Research
Department of Public Health
University of Southern Denmark
Esbjerg
6700
Denmark

ORCID ID	0000-0001-9379-3844
Phone	+45 (0)65504210
Email	cstock@health.sdu.dk

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Does a virtual reality-based game improve alcohol resistance skills among adolescents? A cluster randomised controlled trial
Study acronym	VR FestLab
Study objectives	Current study hypothesis as of 02/02/2021: The main hypothesis is that adolescents who experience “VR FestLab" score higher in drinking refusal self-efficacy (DRSQ) at first follow-up 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. _____ Previous 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(s)	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
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	Current primary outcome measure as of 02/02/2021: 1. Resistance towards peer pressure to drink measured by the Social Pressure subscale of the DRSEQ-R at baseline and at first follow up (immediately after the intervention) _____ Previous 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)
Key secondary outcome measure(s)	Current secondary outcome measures as of 02/02/2021: 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 8. Drug refusal skills measured using the Brief Assessment Tool for the Life Skills Training Drug-Abuse at baseline, first follow up, and second follow up first follow up 9. Resistance towards peer pressure to drink measured by the Social Pressure subscale of the DRSEQ-R at baseline and at second follow-up 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. _____ Previous 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.
Completion date	17/05/2021

Eligibility

Participant type(s)	Healthy volunteer
Age group	Child
Lower age limit	15 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	420
Total final enrolment	573
Key inclusion criteria	1. Public primary/elementary schools in the Region of Southern Denmark 2. Students aged 15 – 18 3. Males/females/diverse
Key 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
Date of first enrolment	01/06/2020
Date of final enrolment	05/07/2020

Locations

Countries of recruitment

Denmark

Study participating centre

University of Southern Denmark

Niels Bohrs Vej 9-10
Esbjerg
6700
Denmark

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		10/03/2022	14/03/2022	Yes	No
Other publications	intervention design article	09/02/2020	02/02/2021	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/03/2022: Publication reference added.
23/12/2021: The following changes were made to the trial record:
1. The overall end date was changed from 17/06/2021 to 17/05/2021.
2. The intention to publish date was changed from 30/12/2021 to 30/06/2022.
3. The plain English summary was updated to reflect these changes.
05/08/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/07/2021 to 05/07/2020.
2. The overall trial end date has been changed from 31/07/2021 to 17/06/2021 and the plain English summary has been updated to reflect this change.
3. The total final enrolment number has been added.
02/02/2021: The following changes were made to the trial record:
1. The hypothesis was changed.
2. The primary outcome measure was changed.
3. The secondary outcome measures were changed.
4. The recruitment end date was changed from 01/02/2021 to 01/07/2021.
5. The intention to publish date was changed from 30/10/2021 to 30/12/2021.
6. Publication reference added.
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.