NCT06612801

Brief Summary

To test the efficacy of the REThink therapeutic game in training emotion regulation abilities of children and adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 23, 2024

Last Update Submit

September 23, 2024

Conditions

Keywords

online gametherapeutic gamedigital interventionREThink gameemotion regulation abilitiesirrationality

Outcome Measures

Primary Outcomes (4)

  • Emotion regulation abilities

    The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 -strong disagreement to 5 - strong agreement-; where higher scores represent better emotional regulation abilities. The scale has two subscales namely, emotional control ( lowest score 8 and highest 40) and emotional awareness subscales (lowest score 5, and highest 25).

    baseline assessment, one week before starting the intervention

  • Changes in emotion regulation abilities

    The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 -strong disagreement to 5 - strong agreement-; where higher scores represent better emotional regulation abilities. The scale has two subscales namely, emotional control ( lowest score 8 and highest 40) and emotional awareness subscales (lowest score 5, and highest 25).

    post-test assessment, one week after finishing the intervention

  • Irrationality

    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 before starting the intervention

  • Changes in irrationality

    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.

    post-test assessment, one week after finishing the intervention

Other Outcomes (1)

  • Mental health symthoms

    baseline assessment, inclusion criteria

Study Arms (2)

Experimental: REThink therapeutic game

EXPERIMENTAL

Participants in the experimental group will received the game-based intervention called REThink Game

Behavioral: The REThink Game

Control: Care as usual

NO INTERVENTION

Participants in the control group do not receive an intervention but they have access to standard resources from the school

Interventions

REThink is an online therapeutic game designed to improve the emotional well-being of young people, based on the principles of Rational Emotive Behavior Therapy (REBT). The game features a character named RETMAN, who leads players through seven levels, each dedicated to teaching a particular emotional regulation skill. Each level consists of three sub-levels that gradually become more challenging. REThink can be utilized as a standalone intervention, as a complement to self-help psychotherapeutic methods, or for focused skills training in emotional regulation. Each level trains a specific emoion-regulation skills such as emotion recognition, relaxation, cognitive change, problem solving, compassion and self-compassion.

Experimental: REThink therapeutic game

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children and adolescents aged 8 to 12 years
  • non-clinical levels of mental health symptoms on any SDQ subscale or total score
  • parental consent provided

You may not qualify if:

  • intellectual disability or physical limitations precluding the use of the online game
  • does not have parental informed consent
  • clinical or subclinical level on the SDQ measure, total score, or any subscale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Romania

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Ph.D

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 25, 2024

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

July 31, 2022

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations