Testing the Efficacy of the REThink Emotions Platform in a Full-scale SMART Study

Study Overview
=================
Brief Summary
-----------------
This activity will have the objective of testing the validity of the integrated in-game assessment and personalized REThinkEMOTIONS platform in the prevention of emotional disorders in youth.

Official Title
-----------------
Testing the Efficacy of the REThink Emotions Platform in a Full-scale SMART Study

Conditions
-----------------
Emotional Regulation

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children and adolescents between 8 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
-----------------
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: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REThink game<br>Each recruited participant randomized in the experimental group will receive the REThink game app. | Other: REThink Game<br>* REThink Game is the therapeutic game that uses psychological science to help youths find their superhero emotional strengths! It is composed of seven levels, each training a specific emotion regulation ability: emotion recognition, mindfulness and relaxation, cognitive change, positive bias, distinction between useful and useless thoughts, problem solving and compassion.<br>|
| Active Comparator: MoodWheel<br>The participants randomized in the control group will complete the MoodWheel app. | Other: MoodWheel<br>* Mood Wheel is a web and mobile-based app that uses experience sampling procedures for the assessment of current/previous distress and positive emotions. The aim of the app is to inquire about the valence, control and functionality of users' emotions.<br>|
| Experimental: PsyPills<br>Participants from experimental group who do not respond to REThink game alone will receive the PsyPills app | Other: REThink Game<br>* REThink Game is the therapeutic game that uses psychological science to help youths find their superhero emotional strengths! It is composed of seven levels, each training a specific emotion regulation ability: emotion recognition, mindfulness and relaxation, cognitive change, positive bias, distinction between useful and useless thoughts, problem solving and compassion.<br>Other: PsyPills<br>* PsyPills is a self-help psycho-educational instrument intended to build stress resilience and to target (only) mild and transient negative mood states, alone or in combination with other methods/instruments. Psychological Pills (PsyPills) are inspired by Rational-Emotive & Cognitive-Behavioral Therapy (CBT/REBT), which has strong evidence for its efficacy/effectiveness in human development/health promotion and in the treatment of a variety of psychological conditions. The PsyPills app was tested in a pilot study and showed positive effects on reducing distress.<br>|

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 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, pre-intervention | 
| Changes of rational and irrational beliefs | The Child and Adolescent Scale of Irrationality 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) | 
| Fluctuations in of rational and irrational beliefs | The Child and Adolescent Scale of Irrationality 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) | 6 months Follow-up | 
| Levels of emotion-regulation | The Emotion Regulation Index for Children and Adolescents (ERICA) 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, pre-intervention | 
| Changes in emotion-regulation | The Emotion Regulation Index for Children and Adolescents (ERICA). 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) | 
| Fluctuations in emotion-regulation | The Emotion Regulation Index for Children and Adolescents (ERICA). 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, | 6 months Follow-up | 
| Levels of child behavioral difficulties | Strengths and Difficulties Questionnaire (SDQ) is a self-report scale that measures emotional and behavioral difficulties in children and adolescents. Its is composed of items and 25 items ranked on a three points Liker scale from not true to almost true. Greater scores at this scale represent higher level of difficulties. | Pre-intervention (one week before the intervention) | 
| Changes in child behavioral difficulties | Strengths and Difficulties Questionnaire (SDQ) is a self-report scale that measures emotional and behavioral difficulties in children and adolescents. Its is composed of items and 25 items ranked on a three points Liker scale from not true to almost true. Greater scores at this scale represent higher level of difficulties. | Post-intervention (one week after the intervention) | 
| Fluctuations in child behavioral difficulties | Strengths and Difficulties Questionnaire (SDQ) is a self-report scale that measures emotional and behavioral difficulties in children and adolescents. Its is composed of items and 25 items ranked on a three points Liker scale from not true to almost true. Greater scores at this scale represent higher level of difficulties. | 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of emotional distress | The Profile of Emotional Distress (PED) is a is a 40-item self-report instrument measuring functional and dysfunctional negative emotions based on Albert Ellis's binary model of distress, as well as positive emotions. The negative emotion subscales include two dysfunctional emotion dimensions (anxiety and depression) and two functional counterparts (concern and sadness). Responders are asked to assess the degree to which they have experienced each emotion during the previous two weeks, based on a five-point Likert scale ranging from Not at all (0) to Extremely (4). | baseline, pre-intervention | 
| Changes in emotional distress | The Profile of Emotional Distress is a is a 40-item self-report instrument measuring functional and dysfunctional negative emotions based on Albert Ellis's binary model of distress, as well as positive emotions. The negative emotion subscales include two dysfunctional emotion dimensions (anxiety and depression) and two functional counterparts (concern and sadness). Responders are asked to assess the degree to which they have experienced each emotion during the previous two weeks, based on a five-point Likert scale ranging from Not at all (0) to Extremely (4). | Post-intervention (one week after the intervention) | 
| Fluctuations in emotional distress | The Profile of Emotional Distress is a is a 40-item self-report instrument measuring functional and dysfunctional negative emotions based on Albert Ellis's binary model of distress, as well as positive emotions. The negative emotion subscales include two dysfunctional emotion dimensions (anxiety and depression) and two functional counterparts (concern and sadness). Responders are asked to assess the degree to which they have experienced each emotion during the previous two weeks, based on a five-point Likert scale ranging from Not at all (0) to Extremely (4). | 6 months follow-up |