Evaluation of a Serious Game Aimed at Improving Mental Health in Youth.
1 other identifier
interventional
3,000
1 country
14
Brief Summary
The main goal of this study is to evaluate the effectiveness of a serious game aimed at improving mental health in teenagers aged 12-16 years old. This will test the effectiveness by studying the effect on emotion regulation strategies, coping strategies, the presence of cognitive errors and suicidal ideation. Participants will also be asked to evaluate the game. The study is a cluster-randomized controlled trial conducted in secondary schools in Flanders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2020
CompletedStudy Start
First participant enrolled
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
October 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2021
CompletedDecember 10, 2021
December 1, 2021
2 months
October 24, 2020
December 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Dutch version of the Questionnaire for the assessment of emotion regulation in children and adolescents (FEEL-KJ)
A 90-item self-report instrument measuring seven adaptive, five maladaptive, and three external emotion (sadness, anger, and anxiety) regulation strategies. Each item is rated on a 5-point Likert scale from 1 = almost never to 5 = almost always. The score on the adaptive (ranging from 42-210), maladaptive (ranging from 30-150) and external (ranging from 18-90) subscales are considered. The higher the score on a subscale, the greater the disposition to cope with negative emotions in a certain way.
Baseline and posttest (after 2 weeks)
Secondary Outcomes (4)
Children's Coping Strategies Checklist -Revision 1 (CCSC-R1)
Baseline and posttest (after 2 weeks)
Children's Negative Cognitive Error Questionnaire-Revised (CNCEQ-R)
Baseline and posttest (after 2 weeks)
2 subscales of the EMO-check kids
Baseline and posttest (after 2 weeks)
Children's Depression Inventory, version 2 (CDI-2)
Baseline and posttest (after 2 weeks)
Other Outcomes (1)
Game Evaluation
Posttest (after 2 weeks)
Study Arms (2)
Intervention group
EXPERIMENTALThe intervention group gain access to the game after filling in the baseline online questionnaire. The participants are asked to play at least two characters in the game. They have two weeks to play the game.
Control group
NO INTERVENTIONWaitlist control group
Interventions
Eligibility Criteria
You may qualify if:
- Dutch speaking
- having access to a smartphone or tablet
You may not qualify if:
- not being part of the selected classes in the participating schools
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
Study Sites (14)
De!Kunsthumaniora
Antwerp, Belgium
KA Beveren
Beveren, Belgium
VTI Brugge
Bruges, Belgium
GO! Atheneum Denderleeuw
Denderleeuw, Belgium
Kunsthumaniora Sint-Lucas
Ghent, Belgium
Humaniora Kindsheid Jesu
Hasselt, Belgium
Middenschool Kindsheid Jesu
Hasselt, Belgium
GO! Atheneum Heist
Heist-op-den-Berg, Belgium
RHIZO Hotelschool
Kortrijk, Belgium
RHIZO Lyceum OLV Vlaanderen
Kortrijk, Belgium
GO! Campus Redingenhof Leuven
Leuven, Belgium
GO! Atheneum Ninove
Ninove, Belgium
De Burgerschool
Roeselare, Belgium
PITO Stabroek
Stabroek, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gwendolyn Portzky, PhD
University Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2020
First Posted
October 29, 2020
Study Start
October 26, 2020
Primary Completion
December 31, 2020
Study Completion
March 15, 2021
Last Updated
December 10, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share