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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mental Health

Intervention / Treatment
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* Behavioral: Silver


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dutch speaking having access to a smartphone or tablet Exclusion Criteria: not being part of the selected classes in the participating schools

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Behavioral: Silver<br>* A serious game to improve mental health in youth<br>|
| No Intervention: Control group<br>Waitlist control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Coping Strategies Checklist -Revision 1 (CCSC-R1) | 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. | Baseline and posttest (after 2 weeks) | 
| Children's Negative Cognitive Error Questionnaire-Revised (CNCEQ-R) | 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. | Baseline and posttest (after 2 weeks) | 
| 2 subscales of the EMO-check kids | 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. | Baseline and posttest (after 2 weeks) | 
| Children's Depression Inventory, version 2 (CDI-2) | 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. | Baseline and posttest (after 2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide Prevention, Universal Suicide Prevention, Serious Game