Assessment of Emotion-regulation Skills in Game-based Situations

• Sponsor: Babes-Bolyai University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04788901
• Collaborator: The Executive Agency for Higher Education, Research, Development and Innovation Funding (Other)
• Enrollment: 110
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.9
• Patients Per Site Per Month: 12.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emotional Problem	Other: REThink therapeutic game	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: The Validity of In-game Performance Measurements or Scores as Indicators of Children's Emotional Regulation Abilities
• Actual Study Start Date: May 5, 2021
• Actual Primary Completion Date: Jan 15, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Online therapeutic game Participants in this group will have access to the evaluation module of the REThink game.	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.

Outcome Measures

Primary Outcome Measures

1. Emotion-regulation [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,

2. Strengths and difficulties [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.

3. Emotional symptoms [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.

4. Emotion recognition [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".

5. Compassion [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• children and adolescents between 8 and 16 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Babes-Bolyai University	Cluj-Napoca	Cluj	Romania	400540

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oana David, Associate Professor, Babes-Bolyai University
• ClinicalTrials.gov Identifier: NCT04788901
• Other Study ID Numbers: 1693/22.02.2021
• First Posted: Mar 9, 2021
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Oana David, Associate Professor, Babes-Bolyai University: emotional regulation; online therapeutic game; emotional regulation assessment

Study Results

No Results Posted as of Aug 19, 2022