- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06954051
ERFs Game-based Assessment in AYAs: Validation of Game-based Assessment of Emotion Regulation Abilities
Validation of Game-based Assessment of Emotion Regulation Abilities Using the REThink Life Online Game in a Population of Adolescents and Young Adults
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cluj
-
Cluj-Napoca, Cluj, Romania, 400015
- Babes-Bolyai University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adolescents and young adults with between 10 and 24 years old provided with written parental consent where applicable
Exclusion Criteria:
- intellectual disability or physical limitations precluded the use of the computer program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: REThink Life
The participants will complete the scale measurements after receiving the four levels of the REThink Life game, each focusing on an emotion regulation skill and an associated assessment system.
|
REThink Life is a therapeutic game developed by David and collaborators (2019) and it is composed of four levels, each training a different emotion regulation ability (emotion recognition, mindfulness, distinguishing between rational and irrational thoughts, and positive attention bias).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotion regulation
Time Frame: Baseline
|
The Cognitive Emotion Regulation Questionnaire (CERQ-short) is an 18-item scale assessing nine different emotion regulation strategies, namely Self-blame, Other-blame, Rumination, Catastrophizing, Positive refocusing, Planning, Positive reappraisal, Putting into perspective and Acceptance.
Children and adolescents were asked to express the frequency of using each strategy on a 5-point Likert-type scale, from 1 ("almost never") to 5 ("almost always").
Higher scores on adaptive strategies (e.g., positive reappraisal, refocus on planning, positive refocusing, putting into perspective, acceptance) are equivalent to a better outcome (more adaptive coping).
Higher scores on maladaptive strategies (e.g., rumination, catastrophizing, self-blame, other-blame) are equivalent to worse outcomes (less adaptive coping).
|
Baseline
|
|
Behavioral difficulties
Time Frame: Baseline
|
The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire for children aged 2 to 17 years old, encompassing emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Total difficulties score: Sum of all subscales except Prosocial → Range: 0 to 40. Prosocial score is reported separately → Range: 0 to 10. Higher scores on total difficulties and the four problem subscales are equivalent to worse outcomes. Higher scores on the prosocial subscale are equivalent to better outcomes. |
Baseline
|
|
Stress
Time Frame: Baseline
|
The Adolescent Stress Scale (ADOSS) will be used to capture students' level of stress in the following domains: personal, academic, family, and social.
Total score ranges from 20 to 100, with higher scores indicating higher levels of stress.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Oana A. David, Ph.D, Babes-Bolyai University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REThinkRESILIENT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Emotion Regulation
-
VU University of AmsterdamUtrecht UniversityRecruiting
-
Douglas Mental Health University InstituteMcGill University; MedTeq; Natural Sciences and Engineering Research Council,... and other collaboratorsRecruiting
-
Miami UniversityUniversity of California, RiversideWithdrawn
-
University Grenoble AlpsActive, not recruiting
-
University of CyprusUniversity of Crete; VU University of Amsterdam; Eotvos Lorand UniversityRecruiting
-
Miami UniversityUniversity of California, RiversideEnrolling by invitation
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...CompletedEmotion RegulationRomania
-
Virginia Commonwealth UniversityMind and Life Institute, Hadley, MassachusettsCompletedEmotion RegulationUnited States
-
Babes-Bolyai UniversityCompletedEmotion Regulation AbilitiesRomania
-
Maltepe UniversityCompletedStress | Emotion RegulationTurkey
Clinical Trials on REThink Life
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...CompletedStress | Emotion RegulationRomania
-
Babes-Bolyai UniversityNot yet recruitingBullying of Child | Bullying Victimisation | Bullying BehaviorRomania
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...CompletedEmotion RegulationRomania
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...CompletedEmotion Regulation | AssessmentRomania
-
Babes-Bolyai UniversityNot yet recruitingBullying | Bullying of Child | Bullying VictimisationRomania
-
Oana DavidThe Executive Agency for Higher Education, Research, Development and Innovation...Completed
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...CompletedEmotion RegulationRomania
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...Completed
-
Babes-Bolyai UniversityCompletedEmotional StressRomania
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...CompletedEmotional RegulationRomania