NCT04788901

Brief Summary

The aim of the study is to investigate the validity of in-game scores as indicators for emotional regulation abilities in children and adolescence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 5, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

March 4, 2021

Last Update Submit

September 6, 2022

Conditions

Emotional Problem

Keywords

emotional regulationonline therapeutic gameemotional regulation assessment

Outcome Measures

Primary Outcomes (5)

  • Emotion-regulation

    The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,

    Pre-intervention (one day before the intervention)

  • Strengths and difficulties

    Strengths and Difficulties Questionnaire - child version (SDQ; Goodman, 1997). It is a 25-item on a three-point Liker scale, from 0 "not true" to 2 "certainly true" where lower scores represent an improvement or lack of problems.

    Pre-intervention (one day before the intervention)

  • Emotional symptoms

    The Child Behavior Checklist for ages 6-18 (CBCL; Achenbach \& Rescorla, 2001) is a parent-report of child emotional and behavioral problems. Each item is rated on a 3-point Likert-style scale ranging from 0 (not true) to 2 (very true or often true). The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.

    Pre-intervention (one day before the intervention)

  • Emotion recognition

    The Emotion Awareness Questionnaire (EAQ, Rieffe et al., 2008) is a 32-item questionnaire on a three-point Liker scale, from 0 "not true" to 2 "certainly true".

    Pre-intervention (one day before the intervention)

  • Compassion

    Compassion Scale for Children (CSC, Nas \& Sak, 2020) is a 20-items scale rated on a five points Likert scale from "Never" to "Always" where higher scores means higher levels of compassion.

    Pre-intervention (one day before the intervention)

Study Arms (1)

Online therapeutic game

EXPERIMENTAL

Participants in this group will have access to the evaluation module of the REThink game.

Other: REThink therapeutic game

Interventions

REThink therapeutic gameOTHER

REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.

Online therapeutic game

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children and adolescents between 10 and 14 years
  • provided written parental consent

You may not qualify if:

  • Intellectual disability or physical limitations precluded the use of the computer program
  • Had a major mental health disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Cluj, 400540, Romania

Location

Related Publications (1)

  • David OA, Tomoiaga C, Fodor LA. Gamified Assessment of the Emotion Regulation Abilities in Youth: Validation of the REThink Online System. Games Health J. 2024 Jun;13(3):184-191. doi: 10.1089/g4h.2023.0011. Epub 2024 Jan 24.

    PMID: 38265781DERIVED

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 9, 2021

Study Start

May 5, 2021

Primary Completion

January 15, 2022

Study Completion

January 31, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations

RO(1)