REThinkWELL- the Use of Therapeutic Game to Reduce Mental Health Symptoms in Children and Adolescents

July 29, 2024 updated by: Oana David, Babes-Bolyai University
To test the effect of a game-based intervention in reducing clinical and subclinical symptoms of children and adolescents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The general objective of the study is to test the REThink therapeutic game for improvements in clinical and subclinical mental health symptoms in children and adolescents aged 8-16 years old from multiple schools and counties. The game will be used by children and adolescents from the experimental group for a period of four weeks. Pre-test and post-test measurements will be taken.

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • children and adolescents aged 8 to 16 years
  • subclinical level on the SDQ measure, total score, or emotional symptoms
  • parental consent provided

Exclusion Criteria:

  • intellectual disability or physical limitations precluding the use of the online game
  • does not have parental informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REThink game
Participants in this group will have access to the REThink therapeutic game for four weeks
Behavioral: REThink therpeutic game
REThink is an online therapeutic game aimed at enhancing the emotional health of young people, grounded in Rational Emotive Behavior Therapy (REBT). The game features a character named RETMAN, who guides players through seven levels, each focused on teaching a specific emotional regulation skill. Each level has three sub-levels that progressively increase in difficulty. REThink can be used as a standalone intervention, an adjunct to self-help psychotherapeutic approaches, or for targeted skills training.
No Intervention: Care as usual
Participants in the control group do not receive an intervention but they have access to standard resources from the school

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental health
Time Frame: baseline assessment, one week prior to the intervention
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997). The scale has 25-items within its five subscales, namely emotional symptoms (ES), conduct problems (CP), hyperactivity/inattention (HY), peer relationship (PR) problems and prosocial behavior (PS) and total mental health difficulties score (MHD). The items are rated on a 3-point Likert scale, from 0 (not true) to 2 (certainly true). The minimum score is 0 and the maximum is 40. Higher scores represent higher level of mental health difficulties.
baseline assessment, one week prior to the intervention
Changes in mental health
Time Frame: post-test assessment, one week after the intervention
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997). The scale has 25-items within its five subscales, namely emotional symptoms (ES), conduct problems (CP), hyperactivity/inattention (HY), peer relationship (PR) problems and prosocial behavior (PS) and total mental health difficulties score (MHD). The items are rated on a 3-point Likert scale, from 0 (not true) to 2 (certainly true). The minimum score is 0 and the maximum is 40. Higher scores represent higher level of mental health difficulties.
post-test assessment, one week after the intervention
Irrationality
Time Frame: baseline assessment, one week prior to the intervention
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. 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"). The minimum score is 28 and the maximum score is 140. Higher scores represent higher levels of irrationality.
baseline assessment, one week prior to the intervention
Changes in irrationality
Time Frame: post-test assessment, one week after the intervention
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. 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"). Higher scores represent higher levels of irrationality.
post-test assessment, one week after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Babes-Bolyai University

Collaborators

The Executive Agency for Higher Education, Research, Development and Innovation Funding

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REThinkWELL

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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