REThink Chronic-A Mobile Therapeutic Game (REThinkChronic)

REThink Chronic-A Mobile Therapeutic Game for the Prevention of Emotional Disorders Among Children Aged 8-16 Years With a Chronic Physical Disease

The general objective of the study is to test the efficacy of an online therapeutic game (REThink Game) for the prevention of emotional disorders in children and adolescents aged between 8-16 years with a chronic physical disease.

Study Overview

• Status: Active, not recruiting
• Conditions: REThink Game; Treatment-as-usual
• Intervention / Treatment: Device: REThink Therapeutic Game; Device: Treatment as Usual

Detailed Description

The objective of the study is to test an online therapeutic game which, being an evidence-based prevention tool for children and adolescents, might contribute to preventing emotional disorders in children and adolescents aged between 8-16 years old diagnosed with a chronic physical disease. REThink is a scientifically validated therapeutic game for children and adolescents to improve their emotional skills. The enrollment will take place both online and in pediatric medical institutions. The research study will include one parent of the eligible child/adolescent. The children and adolescents will be randomized into two equal groups: the intervention group which benefits of the entire REThink game and the treatment-as-usual group which benefits of a free trial version of the app. Three assessments will be performed to evaluate the variables of interest: before intervention (baseline), after intervention (post-intervention), and a follow-up six months after the post-intervention assessment was performed.

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj-Napoca, Romania
    • Babes-Bolyai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• are aged 8 to 16 years old
• are diagnosed with a chronic physical disease
• have consent from the parent or legal tutor to participate in the study
• are fluent in Romanian
• have access to a mobile phone, tablet or laptop

Exclusion Criteria:

• have intellectual disabilities or physical limitations which make it impossible for the them to play the game
• have traumatic brain injuries
• have a diagnosed mental disorder
• demised during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REThink therapeutic game; Game based Cognitive-Behavioral Therapy: REThink therapeutic game is an online therapeutic game developed by David and collaborators (2018). The seven levels of the game were developed based on the REBT model and each level trains an ability: Level 1: identify the emotional reactions, and differentiating between basic emotions, complex emotions, and functional and dysfunctional emotions; Level 2: identify cognitive processes. Level 3: identify the relation between cognitive processes, emotions, and behavioral reactions; Level 4: change irrational cognitions into rational cognitions; Level 5: build problem-solving skills; Level 6: build relaxation skills; Level 7: consolidate of the previous skills and building happiness skills. A new level will be unlocked once every three days. In order for a level to be unlocked, the previous one must have been completed. Duration of the intervention: 21 days (a total of seven levels unlocked every three days)	Device: REThink Therapeutic Game; Game based Cognitive-Behavioral Therapy: REThink therapeutic game is an online therapeutic game developed by David and collaborators (2018). The seven levels of the game were developed based on the REBT model and each level trains an ability: Level 1: identify the emotional reactions, and differentiating between basic emotions, complex emotions, and functional and dysfunctional emotions; Level 2: identify cognitive processes. Level 3: identify the relation between cognitive processes, emotions, and behavioral reactions; Level 4: change irrational cognitions into rational cognitions; Level 5: build problem-solving skills; Level 6: build relaxation skills; Level 7: consolidate of the previous skills and building happiness skills. A new level will be unlocked once every three days. In order for a level to be unlocked, the previous one must have been completed. Duration of the intervention: 21 days (a total of seven levels unlocked every three days)
Active Comparator: Treatment as usual; In the treatment as usual group the child/adolescent benefits from a free trial version of the REThink game which means a shorter version of each level of the game.	Device: Treatment as Usual; Treatment As Usual: In the treatment as usual group the child/adolescent benefits from a free trial version of the REThink game which means a shorter version of each level of the game.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's emotional symptoms	The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997; Goodman et al.,1998)	7 months
Children's negative and positive affect	The Positive and Negative Affect Schedule (PANAS-C; Laurent et al, 1999)	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child emotion regulation	The Cognitive Emotion Regulation Scale (CERQ-K; Orgilés, 2017) aims to identify the emotional cognitive regulation strategies that a child uses after going through negative or stressful events.	7 months
Children's 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.	7 months
Children's quality of life	Youth Quality of Life Instrument - Short Form (YQOL-SF- Edwards, Huebner, Connell & Patrick, 2002; Patrick, Edwards & Topolski, 2002) is a questionnaire which assesses the general quality of life in children and adolescents aged 11 to 18 years old with and without chronic diseases and disabilities. The short form consists of 15 items which evaluate the domains of sense of self, social relationships, environment, and general quality of life.	7 months
Emotional state	MoodWheel (MoodWheel; David, 2016) is a web and mobile application that includes procedures for sampling experience in order to assess present/past emotional difficulties, as well as positive emotions. The purpose of the mobile app is to examine the validity, control and functionality of the emotion felt by the participant.	7 months

Collaborators and Investigators

• Sponsor: Babes-Bolyai University
• Investigators: Study Director: Oana David, PhD, Babes-Bolyai University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: prevention; youth; emotional disorders; chronic physical disease; therapeutic game
• Other Study ID Numbers: REThink Chronic

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