NCT06529510

Brief Summary

To test the effect of a game-based intervention in reducing clinical and subclinical symptoms of children and adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
279

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 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

May 20, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

July 24, 2024

Last Update Submit

July 29, 2024

Conditions

Keywords

online therapeutic gamegame-based CBTemotional problemsmental healthchildren and adolescents

Outcome Measures

Primary Outcomes (4)

  • Mental health

    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

    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

    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

    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

Study Arms (2)

REThink game

EXPERIMENTAL

Participants in this group will have access to the REThink therapeutic game for four weeks

Behavioral: REThink therpeutic game

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 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.

REThink game

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Romania

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

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

Study Record Dates

First Submitted

July 24, 2024

First Posted

July 31, 2024

Study Start

May 20, 2021

Primary Completion

July 31, 2022

Study Completion

August 30, 2022

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations