- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04788901
Assessment of Emotion-regulation Skills in Game-based Situations
September 6, 2022 updated by: Oana David, Babes-Bolyai University
The Validity of In-game Performance Measurements or Scores as Indicators of Children's Emotional Regulation Abilities
The aim of the study is to investigate the validity of in-game scores as indicators for emotional regulation abilities in children and adolescence.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
110
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
-
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Cluj
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Cluj-Napoca, Cluj, Romania, 400540
- Babes-Bolyai University
-
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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
6 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Online therapeutic game
Participants in this group will have access to the evaluation module of the REThink game.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotion-regulation
Time Frame: Pre-intervention (one day before the intervention)
|
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
Time Frame: Pre-intervention (one day before the intervention)
|
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)
|
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Emotional symptoms
Time Frame: Pre-intervention (one day before the intervention)
|
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.
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Pre-intervention (one day before the intervention)
|
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Emotion recognition
Time Frame: Pre-intervention (one day before the intervention)
|
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
Time Frame: Pre-intervention (one day before the intervention)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 5, 2021
Primary Completion (Actual)
January 15, 2022
Study Completion (Actual)
January 31, 2022
Study Registration Dates
First Submitted
March 4, 2021
First Submitted That Met QC Criteria
March 8, 2021
First Posted (Actual)
March 9, 2021
Study Record Updates
Last Update Posted (Actual)
September 7, 2022
Last Update Submitted That Met QC Criteria
September 6, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 1693/22.02.2021
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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