An Integrative Platform for Preventing Children's Emotional Disorders

Study Overview
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Brief Summary
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The general objective of the study is to test an online platform for the prevention of emotional disorders in children.

Detailed Description
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The project aims at implementing an integrated online therapeutic platform that will be accessed by youth, parents and clinicians. The main original feature is the integration of state of the art online/mobile and gaming technologies into a unique platform that allows easy access to personalized, accessible and validated prevention. The platform aims to allow access to attractive, easily accessible and evidence-based prevention for youths. The system will be validated in the second step as an integrative, multi-componential and adaptive platform for the prevention of emotional disorders in youth. The platform includes tools that were separately tested in laboratory conditions and found to be effective: the REThink therapeutic video game and the online REThink Parenting and Rational Parent Coach mobile programs.

Official Title
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REThinkWELL: An Evidence-based Integrative Platform for the Prevention of Emotional Disorders in Children

Conditions
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Emotional Problem

Intervention / Treatment
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* Behavioral: REThink therapeutic game
* Behavioral: Online parenting program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children aged 8 to 12 years scores above average at any subscale of Childhood Trauma Questionnaire parental consent provided for the parental intervention: no changes in children's main outcomes following the REThink intervention Exclusion Criteria: intellectual disability or physical limitations precluding the use of the online platform presence of a mental health disorder in the children or their enrolled parent

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 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: Factorial Assignment
Interventional Model Description: The first stage investigates the efficacy of the online REThink therapeutic game in comparison with monitoring in the prevention of emotional disorders for 4 weeks. In the second stage, for the non-responders to the intervention, the online parenting intervention will be implemented, while the other groups will be monitored for other 4 weeks.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REThink game, then responder monitoring<br>Participants in this group will have access to the REThink game for four weeks; based on their response to the intervention, they will be monitored for an additional period of four weeks. | Behavioral: REThink therapeutic game<br>* REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention for the reduction of emotional symptoms in children and adolescents.<br>|
| Experimental: REThink game, then online parent intervention for non-responders<br>Participants who are allocated to the REThink game and do not respond to the four-week intervention will be allocated to the online | Behavioral: REThink therapeutic game<br>* REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention for the reduction of emotional symptoms in children and adolescents.<br>Behavioral: Online parenting program<br>* The online parenting intervention consists of a newly developed parenting program, including rational emotive behavioral therapy and schema therapy principles<br>|
| No Intervention: Monitoring<br>Participants in this arm will be monitored for a total of eight weeks, for comparison with the REThink game intervention (after four weeks) and the online parenting program (after an additional four weeks). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's emotional symptoms | The Child Behavior Checklist for ages 6-18 (CBCL; Achenbach & Rescorla, 2001) is a parent-report of child emotional and behavioral problems. Each item is rated on a 3-point Likert-style scale ranging from 0 (not true) to 2 (very true or often true). The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms. | baseline | 
| Changes in children's emotional symptoms - immediately | The Child Behavior Checklist for ages 6-18 (CBCL; Achenbach & Rescorla, 2001) is a parent-report of child emotional and behavioral problems. Each item is rated on a 3-point Likert-style scale ranging from 0 (not true) to 2 (very true or often true). The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms. | immediately post first-stage intervention (4 weeks following baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child irrationality | The Child and Adolescent Scale of Irrationality Bernard ME, Cronan F (1999) The child and adolescent scale of irrationality: validation data and mental health correlates. J Cogn Psychother 13:121-132 | baseline | 
| Child trauma | CTQ - Childhood Trauma Questionnaire Bernstein, D. P., Stein, J. A., Newcomb, M. D., Walker, E., Pogge, D., Ahluvalia, T., ... & Zule, W. (2003). Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child abuse & neglect, 27(2), 169-190. | baseline | 
| Child behavioral difficulties | SDQ - Strengths and Difficulties Questionnaire Goodman R, Meltzer H, Bailey V (1998) The strengths and difficulties questionnaire: a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry 7:125-130 | baseline | 
| Changes in child irrationality | The Child and Adolescent Scale of Irrationality Bernard ME, Cronan F (1999) The child and adolescent scale of irrationality: validation data and mental health correlates. J Cogn Psychother 13:121-132 | immediately post first-stage intervention (4 weeks following baseline) | 
| Changes in child behavioral difficulties | SDQ - Strengths and Difficulties Questionnaire Goodman R, Meltzer H, Bailey V (1998) The strengths and difficulties questionnaire: a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry 7:125-130 | immediately post first-stage intervention (4 weeks following baseline) | 
| 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. | immediately post first-stage intervention (4 weeks following baseline) | 

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