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Completed

NCT Number: NCT05257642

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

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

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Key information

Conditions

Emotion Regulation Behavior Emotional Regulation Self-Control Social Behavior

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University

Cluj-Napoca, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REThink game

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.

Primary outcomes

  1. Levels of rational and irrational beliefs

    Time frame: Pre-intervention (one week before the intervention)

    The Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999) will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement")

  2. Changes in rational and irrational beliefs

    Time frame: Post-intervention (one week afterthe intervention)

    The Child and Adolescent Scale of Irrationality (CASI, Bernard & Cronan, 1999) will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement")

  3. Levels of mindfulness

    Time frame: Pre-intervention (one week before the intervention)

    The Mindfulness Awarness Attention Scale - Child version (MAAS-C, Lawlor, Reichl & Zumbo, 2014) is a 15-items questionnaire rated on a 6 points Likert scale from "almost never" to "almost every time" where higher scores means higher mindfulness.

  4. Changes in levels of mindfulness

    Time frame: Post-intervention (one week afterthe intervention)

    The Mindfulness Awarness Attention Scale - Child version (MAAS-C, Lawlor, Reichl & Zumbo, 2014) is a 15-items questionnaire rated on a 6 points Likert scale from "almost never" to "almost every time" where higher scores means higher mindfulness.

  5. Levels of well-being

    Time frame: Pre-intervention (one week before the intervention)

    WHO-5 Well-being Index

  6. Changes in levels of well-being

    Time frame: Post-intervention (one week afterthe intervention)

    WHO-5 Well-being Index

  7. Levels of emotion-regulation

    Time frame: Pre-intervention (one week 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,

  8. Changes in levels of emotion-regulation

    Time frame: Post-intervention (one week afterthe 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,

  9. Level of distress

    Time frame: Pre-intervention (one week before the intervention)

    Measured with Profile of Emotional Distress

  10. Changes in level of distress

    Time frame: Post-intervention (one week afterthe intervention)

    Measured with Profile of Emotional Distress

  11. Children Emotional Abilities

    Time frame: Pre-intervention (one week before the intervention)

    The Cognitive Emotion Regulation Questionnaire - Short (Garnefski & Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.

  12. Changes in children Emotional Abilities

    Time frame: Post-intervention (one week afterthe intervention)

    The Cognitive Emotion Regulation Questionnaire - Short (Garnefski & Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Collaborators

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

Registry information

Official study title

Testing the Usability of the REThink Game and the Efficacy of Its Main Game-based ER Strategies on the Stress Reactivity of Children and Adolescents

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2022
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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