REThinkChronic: REThink Chronic-A Mobile Therapeutic Game

Sponsor
Babes-Bolyai University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05163938
Collaborator
(none)
158
1
2
10.7
14.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: REThink Therapeutic Game
  • Device: Treatment as Usual
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
158 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
REThink mobile therapeutic game intervention group and Treatment-as-usual group which receives the trial version of the app.REThink mobile therapeutic game intervention group and Treatment-as-usual group which receives the trial version of the app.
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
REThink Chronic-A Mobile Therapeutic Game for the Prevention of Emotional Disorders Among Children Aged 8-16 Years With a Chronic Physical Disease
Actual Study Start Date :
Jan 10, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Children's emotional symptoms [7 months]

    The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997; Goodman et al.,1998)

  2. Children's negative and positive affect [7 months]

    The Positive and Negative Affect Schedule (PANAS-C; Laurent et al, 1999)

Secondary Outcome Measures

  1. Child emotion regulation [7 months]

    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.

  2. Children's irrational beliefs [7 months]

    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.

  3. Children's quality of life [7 months]

    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.

  4. Emotional state [7 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Babes-Bolyai University Cluj-Napoca Romania

Sponsors and Collaborators

  • Babes-Bolyai University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oana David, Professor, Babes-Bolyai University
ClinicalTrials.gov Identifier:
NCT05163938
Other Study ID Numbers:
  • REThink Chronic
First Posted:
Dec 20, 2021
Last Update Posted:
Mar 3, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Oana David, Professor, Babes-Bolyai University

Study Results

No Results Posted as of Mar 3, 2022