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Completed

NCT Number: NCT04608578

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

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.

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Key information

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

De!Kunsthumaniora, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dutch speaking
  • having access to a smartphone or tablet

Exclusion criteria

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

Treatment and study plan

Silver

Behavioral

A serious game to improve mental health in youth

Primary outcomes

  1. The Dutch version of the Questionnaire for the assessment of emotion regulation in children and adolescents (FEEL-KJ)

    Time frame: 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 outcomes

  1. Children's Coping Strategies Checklist -Revision 1 (CCSC-R1)

    Time frame: 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. Children's Negative Cognitive Error Questionnaire-Revised (CNCEQ-R)

    Time frame: 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.

  3. 2 subscales of the EMO-check kids

    Time frame: 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.

  4. Children's Depression Inventory, version 2 (CDI-2)

    Time frame: 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 outcomes

  1. Game Evaluation

    Time frame: Posttest (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').

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 29, 2020
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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