Intervention in a Small-scale Study of Game Based Cognitive Change Skills

Study Overview
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Brief Summary
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This activity will have the objectives of preliminary testing user satisfaction, the feasibility of the platform and its preliminary efficacy

Detailed Description
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Preliminary efficacy will be tested in an emotion-regulation framework. Children included in this study will be allocated to play Level 4 of the REThink game on cognitive change or to no intervention Control condition. Children and adolescents in the intervention group will be distributed afterwards in two groups: with or without ecological momentary intervention (EMI) using the PsyPills app for following-up with the cognitive change ER personalized strategy reminder during a real exam situation. Outcomes considered will be stress reactivity (both subjective and physiological) using EMA before, during and after the test (Colombo et al., 2020), and cognitive change, namely irrational and rational beliefs, and reflective functioning improvements.

Official Title
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Testing the Modular Intervention in a Small-scale Study of Game Based Cognitive Change ER Skills Coaching With or Without EMI

Conditions
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Emotion Regulation

Intervention / Treatment
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* Behavioral: Rethink game
* Behavioral: PsyPills


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children and adolescents between 10 and 16 years old provided written parental consent able to access mobile/internet applications on their device Exclusion Criteria: Intellectual disability or physical limitations precluded the use of the computer program Had a major mental health disorder

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rethink game plus PsyPills<br>Rethink game followed by PsyPills | Behavioral: 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>Behavioral: PsyPills<br>* PsyPills is a mobile app designed to provide personalized psychological pills<br>|
| Experimental: Rethink Game<br>Rethink game only | Behavioral: 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<br>Control group | |

What is the study measuring?
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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) | Baseline | 
| Changes in 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) | Post-intervention (one week after the 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, | Baseline | 
| 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 after the intervention) | 
| Level of distress | Measured with Profile of Emotional Distress | Post-intervention (one week after the intervention) | 
| Emotion regulation 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. | Baseline | 
| Changes in emotion regulation 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 after the intervention) | 
| Reflective functioning | The Reflective Functioning Questionnaire (RFQ ) is a 8-items questionnaire rated on a 7 points Likert scale from Strongly disagree to Strongly agree where higher scores represents a higher level of reflective functioning. | Baseline | 
| Changes in reflective functioning | The Reflective Functioning Questionnaire (RFQ ) is a 8-items questionnaire rated on a 7 points Likert scale from Strongly disagree to Strongly agree where higher scores represents a higher level of reflective functioning. | Post-intervention (one week after the intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emotional regulation, children and adolescents, online therapeutic game, emotional problems