Evaluation of a Serious Game Aimed at Improving Mental Health in Youth.

Not Applicable

Completed

• Conditions: Mental Health
• Interventions: Behavioral: Silver

• Registration Number: NCT04608578
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-24
• Study First Submitted QC: 2020-10-24
• Study Start: 2020-10-26
• Study First Posted: 2020-10-29
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Dutch speaking
• having access to a smartphone or tablet

Exclusion Criteria

• not being part of the selected classes in the participating schools

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Silver	The 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.

Primary Outcome Measures

Name	Time	Method
The Dutch version of the Questionnaire for the assessment of emotion regulation in children and adolescents (FEEL-KJ)	Baseline and posttest (after 2 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Children's Coping Strategies Checklist -Revision 1 (CCSC-R1)	Baseline and posttest (after 2 weeks)	3 subscales on cognitive coping strategies (i.e., optimism, control, and seeking understanding) are used. Each subscale has 4 items and all items are scored on a 4-point Likert scale from 1 = never to 4 = most of the time. For each subscale the minimum total score is 4 and the maximum score 16. The higher the mean score on the subscale, the more often the cognitive coping strategy is used.
2 subscales of the EMO-check kids	Baseline and posttest (after 2 weeks)	Two subscales of the EMO-Check kids are used i.e., Emotional clearness and Understanding emotions. They measure strategies to cope with emotions on a 5-point Likert scale from 0 = not at all to 4 = (almost) always. The score on a subscale ranges from 0 to 12. Higher score indicate more use a certain emotion regulation strategy.
Children's Depression Inventory, version 2 (CDI-2)	Baseline and posttest (after 2 weeks)	A 28-item self-report scale measuring depressive symptoms experienced over the previous 2 weeks. Items are score on a scale from 0 to 2. Total scores range from 0 to 56. Higher scores indicate greater severity of depressive symptomatology.
Children's Negative Cognitive Error Questionnaire-Revised (CNCEQ-R)	Baseline and posttest (after 2 weeks)	The scale assess cognitive Errors and has 5 subscales and 16 items in total. The items are rated on a 5-point Likert scale from 1 = not at all like I would think to 5 = almost exactly like I would think. Total scores range from 16-80. Higher scores reflect more distorted cognitive processes.

Trial Locations

Locations (14)

RHIZO Hotelschool; 🇧🇪 Kortrijk, Belgium

Humaniora Kindsheid Jesu; 🇧🇪 Hasselt, Belgium

Kunsthumaniora Sint-Lucas; 🇧🇪 Gent, Belgium

GO! Campus Redingenhof Leuven; 🇧🇪 Leuven, Belgium

GO! Atheneum Denderleeuw; 🇧🇪 Denderleeuw, Belgium

De!Kunsthumaniora; 🇧🇪 Antwerpen, Belgium

Middenschool Kindsheid Jesu; 🇧🇪 Hasselt, Belgium

GO! Atheneum Ninove; 🇧🇪 Ninove, Belgium

De Burgerschool; 🇧🇪 Roeselare, Belgium

KA Beveren; 🇧🇪 Beveren, Belgium

VTI Brugge; 🇧🇪 Brugge, Belgium

RHIZO Lyceum OLV Vlaanderen; 🇧🇪 Kortrijk, Belgium

GO! Atheneum Heist; 🇧🇪 Heist-op-den-Berg, Belgium

PITO Stabroek; 🇧🇪 Stabroek, Belgium