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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04608578
Enrollment
3000
Registered
2020-10-29
Start date
2020-10-26
Completion date
2021-03-15
Last updated
2021-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health

Keywords

Suicide Prevention, Universal Suicide Prevention, Serious Game

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.

Interventions

BEHAVIORALSilver

A serious game to improve mental health in youth

Sponsors

University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

* Dutch speaking * having access to a smartphone or tablet

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.
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.
2 subscales of the EMO-check kidsBaseline 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.

Other

MeasureTime frameDescription
Game EvaluationPosttest (after 2 weeks)14 statements regarding the effect, content and usefulness of the game. Items were rated on a 5-point Likert scale (1 = 'completely disagree'; 5 = 'completely agree').

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026