NCT06954051

Brief Summary

This activity will have the objective of establishing the validity of in-game emotion regulation abilities assessment for adolescents and young adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

April 24, 2025

Last Update Submit

August 27, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Emotion regulation

    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

    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

    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

Study Arms (1)

REThink Life

OTHER

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.

Other: REThink Life

Interventions

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).

REThink Life

Eligibility Criteria

Age10 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • adolescents and young adults with between 10 and 24 years old provided with written parental consent where applicable

You may not qualify if:

  • intellectual disability or physical limitations precluded the use of the computer program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Cluj, 400015, Romania

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Oana A. David, Ph.D

    Babes-Bolyai University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 1, 2025

Study Start

February 15, 2025

Primary Completion

June 15, 2025

Study Completion

June 30, 2025

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations