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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04788901
Other study ID # 1693/22.02.2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 5, 2021
Est. completion date January 31, 2022

Study information

Verified date September 2022
Source Babes-Bolyai University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date January 31, 2022
Est. primary completion date January 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 14 Years
Eligibility Inclusion Criteria: - children and adolescents between 10 and 14 years - provided written parental consent Exclusion Criteria: - Intellectual disability or physical limitations precluded the use of the computer program - Had a major mental health disorder

Study Design


Related Conditions & MeSH terms


Intervention

Other:
REThink therapeutic game
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.

Locations

Country Name City State
Romania Babes-Bolyai University Cluj-Napoca Cluj

Sponsors (2)

Lead Sponsor Collaborator
Babes-Bolyai University The Executive Agency for Higher Education, Research, Development and Innovation Funding

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
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