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

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608578
• Other study ID #: BC - 07288
• Status: Completed
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: December 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: March 15, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

Inclusion Criteria:

• Dutch speaking
• having access to a smartphone or tablet

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Mental Health

Intervention

Behavioral:
• Silver
A serious game to improve mental health in youth

Locations

Country	Name	City	State
Belgium	De!Kunsthumaniora	Antwerpen
Belgium	KA Beveren	Beveren
Belgium	VTI Brugge	Brugge
Belgium	GO! Atheneum Denderleeuw	Denderleeuw
Belgium	Kunsthumaniora Sint-Lucas	Gent
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

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Game Evaluation	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').	Posttest (after 2 weeks)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)