Testing the Efficacy of REThink Main Game-based ER Strategies on the Stress Reactivity

Emotion Regulation Clinical Trial

Official title:

Testing the Usability of the REThink Game and the Efficacy of Its Main Game-based ER Strategies on the Stress Reactivity of Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05257642
• Other study ID #: REThinkEMOTIONS
• Status: Completed
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: November 2022
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This activity will aim to test the comparative efficacy of the main game-based emotion-regulation abilities training of the REThink online game: cognitive change, biofeedback and problem-solving in reducing stress reactivity of the children and adolescents

Description:

Children included in this study (aged 8-16 years, G*Power estimated N=98) will be allocated to one of the three experimental conditions (cognitive change, biofeedback and problem-solving game based training based on the REThink online game levels), or no intervention Control condition. All children will be exposed afterwards to psychosocial stress in the form of peer rejection "ball toss" task. It will be measure both game-based skills outcomes, and EMA stress reactivity outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

children and adolescents between 8 and 16 years provided written parental consent Exclusion Criteria: Intellectual disability or physical limitations precluded the use of the computer program Had a major mental health disorder

Related Conditions & MeSH terms

• Emotion Regulation

Intervention

Other:
• REThink Game
REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca

Sponsors (2)

Lead Sponsor	Collaborator
Babes-Bolyai University	The Executive Agency for Higher Education, Research, Development and Innovation Funding

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of rational and irrational beliefs	The Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999) will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement")	Pre-intervention (one week before the intervention)
Primary	Changes in rational and irrational beliefs	The Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999) will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement")	Post-intervention (one week afterthe intervention)
Primary	Levels of mindfulness	The Mindfulness Awarness Attention Scale - Child version (MAAS-C, Lawlor, Reichl & Zumbo, 2014) is a 15-items questionnaire rated on a 6 points Likert scale from "almost never" to "almost every time" where higher scores means higher mindfulness.	Pre-intervention (one week before the intervention)
Primary	Changes in levels of mindfulness	The Mindfulness Awarness Attention Scale - Child version (MAAS-C, Lawlor, Reichl & Zumbo, 2014) is a 15-items questionnaire rated on a 6 points Likert scale from "almost never" to "almost every time" where higher scores means higher mindfulness.	Post-intervention (one week afterthe intervention)
Primary	Levels of well-being	WHO-5 Well-being Index	Pre-intervention (one week before the intervention)
Primary	Changes in levels of well-being	WHO-5 Well-being Index	Post-intervention (one week afterthe intervention)
Primary	Levels of emotion-regulation	The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker & Easterbrooks, 2001). It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,	Pre-intervention (one week before the intervention)
Primary	Changes in levels of emotion-regulation	The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker & Easterbrooks, 2001). It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,	Post-intervention (one week afterthe intervention)
Primary	Level of distress	Measured with Profile of Emotional Distress	Pre-intervention (one week before the intervention)
Primary	Changes in level of distress	Measured with Profile of Emotional Distress	Post-intervention (one week afterthe intervention)
Primary	Children Emotional Abilities	The Cognitive Emotion Regulation Questionnaire - Short (Garnefski & Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.	Pre-intervention (one week before the intervention)
Primary	Changes in children Emotional Abilities	The Cognitive Emotion Regulation Questionnaire - Short (Garnefski & Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.	Post-intervention (one week afterthe intervention)