An Integrative Platform for Promoting Children's Emotional Health

REThinkWELL: An Evidence-based Integrative Platform for the Prevention of Emotional Disorders in Children and Promotion of Children's Emotional Health

The general objective of the study is to test an online platform for the promotion of emotional health in children

Study Overview

• Status: Completed
• Conditions: Emotional Problem
• Intervention / Treatment: Behavioral: REThink therapeutic game; Behavioral: Online parenting program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj-Napoca, Romania, 400015
    • Oana David

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REThink game, then responder monitoring; 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; 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.
Experimental: REThink game, then online parent intervention for non-responders; 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; 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.; Behavioral: Online parenting program; The online parenting intervention consists of a newly developed parenting program, including rational emotive behavioral therapy and schema therapy principles
No Intervention: Monitoring; 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?

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 & 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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting practices	The Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS; Cardamone-Breene et al., 2017) is a 79-item self-report measure of parenting practices. The instrument comprises nine subscales (6-12 items each), corresponding to nine sets of parenting practices that are part of the national Australian guidelines for helping reduce depression in children and adolescents. Most items are scored on a Likert scale measuring the frequency of distinct parenting behaviors (never, rarely, sometimes, and often).	immediately post first-stage intervention (4 weeks following baseline)
Changes in parenting practices	The Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS; Cardamone-Breene et al., 2017) is a 79-item self-report measure of parenting practices. The instrument comprises nine subscales (6-12 items each), corresponding to nine sets of parenting practices that are part of the national Australian guidelines for helping reduce depression in children and adolescents. Most items are scored on a Likert scale measuring the frequency of distinct parenting behaviors (never, rarely, sometimes, and often).	post second-stage intervention (8 weeks following baseline)
Changes in parenting practices - follow up	The Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS; Cardamone-Breene et al., 2017) is a 79-item self-report measure of parenting practices. The instrument comprises nine subscales (6-12 items each), corresponding to nine sets of parenting practices that are part of the national Australian guidelines for helping reduce depression in children and adolescents. Most items are scored on a Likert scale measuring the frequency of distinct parenting behaviors (never, rarely, sometimes, and often).	6-month follow-up
Changes in parenting practices - follow up one year	The Parenting to Reduce Adolescent Depression and Anxiety Scale (PRADAS; Cardamone-Breene et al., 2017) is a 79-item self-report measure of parenting practices. The instrument comprises nine subscales (6-12 items each), corresponding to nine sets of parenting practices that are part of the national Australian guidelines for helping reduce depression in children and adolescents. Most items are scored on a Likert scale measuring the frequency of distinct parenting behaviors (never, rarely, sometimes, and often).	12-month follow-up
Parent distress	The Profile of Emotional Distress (PED; Opris & Macavei, 2005) 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).	immediately post first-stage intervention (4 weeks following baseline)
Changes in parent distress	The Profile of Emotional Distress (PED; Opris & Macavei, 2005) 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 second-stage intervention (8 weeks following baseline)
Changes in parent distress -follow up	The Profile of Emotional Distress (PED; Opris & Macavei, 2005) 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-month follow-up
Changes in parent distress -follow up one year	The Profile of Emotional Distress (PED; Opris & Macavei, 2005) 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).	12-month follow-up
Parent beliefs	The Parent Rational and Irrational Beliefs Scale (P-RIBS; Gavita, DiGiuseppe, David & DelVecchio, 2011) is a 24-item measure of rational and irrational evaluative processes in parents regarding child behavior and the parent role. Items are assessed on a 5- point Likert scale, from "Strongly disagree" (1) to "Strongly agree" (5).	immediately post first-stage intervention (4 weeks following baseline)
Changes in parent beliefs	The Parent Rational and Irrational Beliefs Scale (P-RIBS; Gavita, DiGiuseppe, David & DelVecchio, 2011) is a 24-item measure of rational and irrational evaluative processes in parents regarding child behavior and the parent role. Items are assessed on a 5- point Likert scale, from "Strongly disagree" (1) to "Strongly agree" (5).	post second-stage intervention (8 weeks following baseline)
Changes in parent beliefs - follow up	The Parent Rational and Irrational Beliefs Scale (P-RIBS; Gavita, DiGiuseppe, David & DelVecchio, 2011) is a 24-item measure of rational and irrational evaluative processes in parents regarding child behavior and the parent role. Items are assessed on a 5- point Likert scale, from "Strongly disagree" (1) to "Strongly agree" (5).	6-month follow-up
Changes in parent beliefs - follow up one year	The Parent Rational and Irrational Beliefs Scale (P-RIBS; Gavita, DiGiuseppe, David & DelVecchio, 2011) is a 24-item measure of rational and irrational evaluative processes in parents regarding child behavior and the parent role. Items are assessed on a 5- point Likert scale, from "Strongly disagree" (1) to "Strongly agree" (5).	12-month follow-up
Parent emotion regulation	The Parent Emotion Regulation Scale (PERS; Perreira, Barros, Roberto, & Marques, 2017) is a 20-item measure of parents' emotion regulation abilities. The PERS assesses four dimensions of parent emotion regulation (orientation to the child's emotions, avoidance of the child's emotions, lack of emotional control and acceptance of the child's and their own emotions), using a five-point Likert scale (from "Never or almost never" to "Always or almost always").	immediately post first-stage intervention (4 weeks following baseline)
Changes in parent emotion regulation	The Parent Emotion Regulation Scale (PERS; Perreira, Barros, Roberto, & Marques, 2017) is a 20-item measure of parents' emotion regulation abilities. The PERS assesses four dimensions of parent emotion regulation (orientation to the child's emotions, avoidance of the child's emotions, lack of emotional control and acceptance of the child's and their own emotions), using a five-point Likert scale (from "Never or almost never" to "Always or almost always").	post second-stage intervention (8 weeks following baseline)
Changes in parent emotion regulation - follow up	The Parent Emotion Regulation Scale (PERS; Perreira, Barros, Roberto, & Marques, 2017) is a 20-item measure of parents' emotion regulation abilities. The PERS assesses four dimensions of parent emotion regulation (orientation to the child's emotions, avoidance of the child's emotions, lack of emotional control and acceptance of the child's and their own emotions), using a five-point Likert scale (from "Never or almost never" to "Always or almost always").	6-month follow-up
Changes in parent emotion regulation - follow up one year	The Parent Emotion Regulation Scale (PERS; Perreira, Barros, Roberto, & Marques, 2017) is a 20-item measure of parents' emotion regulation abilities. The PERS assesses four dimensions of parent emotion regulation (orientation to the child's emotions, avoidance of the child's emotions, lack of emotional control and acceptance of the child's and their own emotions), using a five-point Likert scale (from "Never or almost never" to "Always or almost always").	12-month follow-up
Child attachment (moderator variable)	The Security Scale (Kerns, Klepac, & Cole, 1996) is a 15-item measure of attachment security in children aged 8 to 12. The scale uses a "some kids... other kids..." format and asks respondents to select the degree to which they feel they are similar to the type of children they have previously selected, using a two-point Likert scale ("Really true for me" or "Sort of true for me".	baseline
Academic burnout	The School Burnout Inventory (Salmela-Aro et al., 2009) consists of 9 items that measure three aspects of school burnout, namely, exhaustion at school, cynicism toward the meaning of school, and the sense of inadequacy at school.	Baseline
Changes in academic burnout	The School Burnout Inventory (Salmela-Aro et al., 2009) consists of 9 items that measure three aspects of school burnout, namely, exhaustion at school, cynicism toward the meaning of school, and the sense of inadequacy at school.	post second-stage intervention (8 weeks following baseline)

Collaborators and Investigators

• Sponsor: Babes-Bolyai University
• Collaborators: The Executive Agency for Higher Education, Research, Development and Innovation Funding

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: children; parenting; emotional problems; online therapeutic game
• Other Study ID Numbers: 2576/ 18.03.2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No