Emotion RegulationNCT05257642
Testing the Efficacy of REThink Main Game-based ER Strategies on the Stress Reactivity
A study testing REThink Game in people with Emotion Regulation, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- REThink Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteRomania
- Study dates
- 10 Mar 2022to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children and adolescents between 8 and 16 years provided written parental consent
Who cannot join
- Intellectual disability or physical limitations precluded the use of the computer program
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
Read the detailed description
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
- Emotion Regulation
- Being tested
- REThink Game
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REThink GameOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Change Groups | Experimental | 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. Receives: Other: REThink Game |
| Mindfulness Groups | Experimental | 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 Receives: Other: REThink Game |
| Positive bias Group | Experimental | 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 Receives: Other: REThink Game |
| Control Group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of rational and irrational beliefs
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")
Measured: Pre-intervention (one week before the intervention)
Changes in rational and irrational beliefs
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")
Measured: Post-intervention (one week afterthe intervention)
Levels of mindfulness
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.
Measured: Pre-intervention (one week before the intervention)
Changes in levels of mindfulness
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.
Measured: Post-intervention (one week afterthe intervention)
Levels of well-being
WHO-5 Well-being Index
Measured: Pre-intervention (one week before the intervention)
Changes in levels of well-being
WHO-5 Well-being Index
Measured: Post-intervention (one week afterthe intervention)
Levels of emotion-regulation
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,
Measured: Pre-intervention (one week before the intervention)
Changes in levels of emotion-regulation
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,
Measured: Post-intervention (one week afterthe intervention)
Level of distress
Measured with Profile of Emotional Distress
Measured: Pre-intervention (one week before the intervention)
Changes in level of distress
Measured with Profile of Emotional Distress
Measured: Post-intervention (one week afterthe intervention)
Children Emotional Abilities
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.
Measured: Pre-intervention (one week before the intervention)
Changes in children Emotional Abilities
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.
Measured: Post-intervention (one week afterthe intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start10 Mar 2022
- Primary completion15 Oct 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Responsible party
- Principal investigator, Oana David, Babes-Bolyai University
- Investigators
- Oana David, Ph.D, Principal investigator, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257642
- Sponsor's protocol ID
- REThinkEMOTIONS
- Status last verified
- Nov 2022
- First submitted
- 16 Feb 2022
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05257642
- Acronym / sponsor ID
- REThinkEMOTIONS
- Conditions
- Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Change Groups | Experimental | Other: REThink GameThe 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. |
| Mindfulness Groups | Experimental | Other: REThink GameThe 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 |
| Positive bias Group | Experimental | Other: REThink GameThe 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 |
| Control Group | No intervention | –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 |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children and adolescents between 8 and 16 years provided written parental consent
Key exclusion criteria (1 listed)
- Intellectual disability or physical limitations precluded the use of the computer program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REThink GameREThink 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. | Other | Cognitive Change Groups, Mindfulness Groups, Positive bias Group |
Primary outcome
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")
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")
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.
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.
Levels of well-being
Time frame: Pre-intervention (one week before the intervention)
WHO-5 Well-being Index
Changes in levels of well-being
Time frame: Post-intervention (one week afterthe intervention)
WHO-5 Well-being Index
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,
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,
Level of distress
Time frame: Pre-intervention (one week before the intervention)
Measured with Profile of Emotional Distress
Changes in level of distress
Time frame: Post-intervention (one week afterthe intervention)
Measured with Profile of Emotional Distress
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oana David, Ph.D principal investigator
Babes-Bolyai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REThink Game in people with Emotion Regulation, run by Babes-Bolyai University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of rational and irrational beliefs (time frame: Pre-intervention (one week before the intervention)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.