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

Study Overview
=================
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

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.

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

Conditions
-----------------
Emotion Regulation

Intervention / Treatment
-----------------
* Other: REThink Game


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Change Groups<br>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<br>* 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.<br>|
| Experimental: Mindfulness Groups<br>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<br>* 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.<br>|
| Experimental: Positive bias Group<br>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<br>* 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.<br>|
| No Intervention: Control Group<br>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 5strong 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 5strong 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 &amp; 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 &amp; 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) |