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
1 other identifier
interventional
146
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedStudy Start
First participant enrolled
March 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2022
CompletedDecember 17, 2024
November 1, 2022
7 months
February 16, 2022
December 12, 2024
Conditions
Outcome Measures
Primary Outcomes (12)
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)
Study Arms (4)
Cognitive Change Groups
EXPERIMENTALThe 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.
Mindfulness Groups
EXPERIMENTALThe 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
Positive bias Group
EXPERIMENTALThe 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
Control Group
NO INTERVENTIONThe participants in this group will complete the pre-test measurements, then they will receive an experimental task Cyberball and complete the post-test measurements
Interventions
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.
Eligibility Criteria
You may qualify if:
- children and adolescents between 8 and 16 years provided written parental consent
You may not qualify if:
- Intellectual disability or physical limitations precluded the use of the computer program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Babes-Bolyai University
Cluj-Napoca, Romania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oana David, Ph.D
Babes-Bolyai University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Ph.D
Study Record Dates
First Submitted
February 16, 2022
First Posted
February 25, 2022
Study Start
March 10, 2022
Primary Completion
October 15, 2022
Study Completion
November 15, 2022
Last Updated
December 17, 2024
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share