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Testing the Efficacy of REThink Main Game-based ER Strategies on the Stress Reactivity

NCT ID: NCT05257642

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2022-11-15

Brief Summary

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This activity will aim to test the comparative efficacy of the main game-based emotion-regulation abilities training of the REThink online game: cognitive change, biofeedback and problem-solving in reducing stress reactivity of the children and adolescents

Detailed Description

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Children included in this study (aged 8-16 years, G\*Power estimated N=98) will be allocated to one of the three experimental conditions (cognitive change, biofeedback and problem-solving game based training based on the REThink online game levels), or no intervention Control condition. All children will be exposed afterwards to psychosocial stress in the form of peer rejection "ball toss" task. It will be measure both game-based skills outcomes, and EMA stress reactivity outcomes.

Conditions

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Emotion Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Cognitive Change Groups

The participants in this group will complete the pre-test measurements, then they will receive a level of the REThink Game that focuses on cognitive change. After playing the game they will receive an experimental task Cyberball and complete the post-test measurements.

Group Type EXPERIMENTAL

REThink Game

Intervention Type OTHER

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.

Mindfulness Groups

The participants in this group will complete the pre-test measurements, then they will receive a level of the REThink Game that focuses on mindfulness and relaxation. After playing the game they will receive an experimental task Cyberball and complete the post-test measurements

Group Type EXPERIMENTAL

REThink Game

Intervention Type OTHER

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.

Positive bias Group

The participants in this group will complete the pre-test measurements, then they will receive a level of the REThink Game that focuses on problem-solving. After playing the game they will receive an experimental task Cyberball and complete the post-test measurements

Group Type EXPERIMENTAL

REThink Game

Intervention Type OTHER

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.

Control Group

The participants in this group will complete the pre-test measurements, then they will receive an experimental task Cyberball and complete the post-test measurements

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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REThink 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Executive Agency for Higher Education, Research, Development and Innovation Funding

OTHER

Sponsor Role collaborator

Babes-Bolyai University

OTHER

Sponsor Role lead

Responsible Party

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Oana David

Professor Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oana David, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Babes-Bolyai University

Locations

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Babes-Bolyai University

Cluj-Napoca, , Romania

Site Status

Countries

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Romania

Other Identifiers

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REThinkEMOTIONS

Identifier Type: -

Identifier Source: org_study_id