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

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

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

Study Overview

• Status: Completed
• Conditions: Emotion Regulation
• Intervention / Treatment: Other: REThink Game

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj-Napoca, Romania
    • Babes-Bolyai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Change Groups; The participants in this group will complete the pre-test measurements, then they will receive a level of the REThink Game that focuses on cognitive change. After playing the game they will receive an experimental task Cyberball and complete the post-test measurements.	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.
Experimental: Mindfulness Groups; The participants in this group will complete the pre-test measurements, then they will receive a level of the REThink Game that focuses on mindfulness and relaxation. After playing the game they will receive an experimental task Cyberball and complete the post-test measurements	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.
Experimental: Positive bias Group; The participants in this group will complete the pre-test measurements, then they will receive a level of the REThink Game that focuses on problem-solving. After playing the game they will receive an experimental task Cyberball and complete the post-test measurements	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.
No Intervention: Control Group; The participants in this group will complete the pre-test measurements, then they will receive an experimental task Cyberball and complete the post-test measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
Levels of well-being	WHO-5 Well-being Index	Pre-intervention (one week before the intervention)
Changes in levels of well-being	WHO-5 Well-being Index	Post-intervention (one week afterthe intervention)
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)
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)
Level of distress	Measured with Profile of Emotional Distress	Pre-intervention (one week before the intervention)
Changes in level of distress	Measured with Profile of Emotional Distress	Post-intervention (one week afterthe intervention)
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)
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)

Collaborators and Investigators

• Sponsor: Babes-Bolyai University
• Collaborators: The Executive Agency for Higher Education, Research, Development and Innovation Funding
• Investigators: Principal Investigator: Oana David, Ph.D, Babes-Bolyai University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): October 15, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: REThinkEMOTIONS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No