Emotion Regulation AbilitiesNCT06612801
REThinkGame4training: Training Emotion Regulation Abilities Using an Online Therapeutic Game
A study testing The REThink Game in people with Emotion Regulation Abilities, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
To test the efficacy of the REThink therapeutic game in training emotion regulation abilities of children and adolescents. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation Abilities
- What is being tested?
- The REThink Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteRomania
- Study dates
- 1 Apr 2021to 31 Jul 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children and adolescents aged 8 to 12 years
- non-clinical levels of mental health symptoms on any SDQ subscale or total score
- parental consent provided
Who cannot join
- intellectual disability or physical limitations precluding the use of the online game
- does not have parental informed consent
- clinical or subclinical level on the SDQ measure, total score, or any subscale
Trial locations and contacts
1 site in 1 country.
About this study
To test the efficacy of the REThink therapeutic game in training emotion regulation abilities of children and adolescents.
Read the detailed description
The primary aim of this study is to evaluate the effectiveness of the REThink therapeutic game in training emotion regulation abilities in children aged 8 to 12 years. The participants will be recruitedfrom various schools and counties, ensuring a diverse sample. Those in the experimental group will engage with the REThink game over a four-week period. To assess the impact of the intervention, standardized pre-test and post-test measures will be administered, allowing for a comparison of mental health outcomes before and after the use of the therapeutic game. The study seeks to determine whether this digital tool can serve as an effective training for improving emotion regulation abilities in this age group.
- Conditions
- Emotion Regulation Abilities
- Being tested
- The REThink Game
- Keywords
- online game, therapeutic game, digital intervention, REThink game, emotion regulation abilities, irrationality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The REThink GameBehavioural
REThink is an online therapeutic game designed to improve the emotional well-being of young people, based on the principles of Rational Emotive Behavior Therapy (REBT). The game features a character named RETMAN, who leads players through seven levels, each dedicated to teaching a particular emotional regulation skill. Each level consists of three sub-levels that gradually become more challenging. REThink can be utilized as a standalone intervention, as a complement to self-help psychotherapeutic methods, or for focused skills training in emotional regulation. Each level trains a specific emoion-regulation skills such as emotion recognition, relaxation, cognitive change, problem solving, compassion and self-compassion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: REThink therapeutic game | Experimental | Participants in the experimental group will received the game-based intervention called REThink Game Receives: Behavioral: The REThink Game |
| Control: Care as usual | No intervention | Participants in the control group do not receive an intervention but they have access to standard resources from the school |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion regulation abilities
The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 -strong disagreement to 5 - strong agreement-; where higher scores represent better emotional regulation abilities. The scale has two subscales namely, emotional control ( lowest score 8 and highest 40) and emotional awareness subscales (lowest score 5, and highest 25).
Measured: baseline assessment, one week before starting the intervention
Changes in emotion regulation abilities
The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 -strong disagreement to 5 - strong agreement-; where higher scores represent better emotional regulation abilities. The scale has two subscales namely, emotional control ( lowest score 8 and highest 40) and emotional awareness subscales (lowest score 5, and highest 25).
Measured: post-test assessment, one week after finishing the intervention
Irrationality
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\"). The minimum score is 28 and the maximum score is 140. Higher scores represent higher levels of irrationality.
Measured: baseline assessment, one week before starting the intervention
Changes in irrationality
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\"). The minimum score is 28 and the maximum score is 140. Higher scores represent higher levels of irrationality.
Measured: post-test assessment, one week after finishing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Apr 2021
- Primary completion1 Apr 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion Regulation AbilitiesStudies 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
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oana David, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612801
- Sponsor's protocol ID
- REThinkGame4training
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 25 Sep 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 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REThinkGame4training: Training Emotion Regulation Abilities Using an Online Therapeutic Game
- ClinicalTrials.gov ID
- NCT06612801
- Acronym / sponsor ID
- REThinkGame4training
- Conditions
- Emotion Regulation Abilities
- Keywords
- online game, therapeutic game, digital intervention, REThink game, emotion regulation abilities, irrationality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 25 Sep 2024 (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.
To test the efficacy of the REThink therapeutic game in training emotion regulation abilities of children and adolescents.
Detailed description
The primary aim of this study is to evaluate the effectiveness of the REThink therapeutic game in training emotion regulation abilities in children aged 8 to 12 years. The participants will be recruitedfrom various schools and counties, ensuring a diverse sample. Those in the experimental group will engage with the REThink game over a four-week period. To assess the impact of the intervention, standardized pre-test and post-test measures will be administered, allowing for a comparison of mental health outcomes before and after the use of the therapeutic game. The study seeks to determine whether this digital tool can serve as an effective training for improving emotion regulation abilities in this age group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: REThink therapeutic game | Experimental | Behavioral: The REThink GameParticipants in the experimental group will received the game-based intervention called REThink Game |
| Control: Care as usual | No intervention | –Participants in the control group do not receive an intervention but they have access to standard resources from the school |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children and adolescents aged 8 to 12 years
- non-clinical levels of mental health symptoms on any SDQ subscale or total score
- parental consent provided
Key exclusion criteria (3 listed)
- intellectual disability or physical limitations precluding the use of the online game
- does not have parental informed consent
- clinical or subclinical level on the SDQ measure, total score, or any subscale
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 |
|---|---|---|
| The REThink GameREThink is an online therapeutic game designed to improve the emotional well-being of young people, based on the principles of Rational Emotive Behavior Therapy (REBT). The game features a character named RETMAN, who leads players through seven levels, each dedicated to teaching a particular emotional regulation skill. Each level consists of three sub-levels that gradually become more challenging. REThink can be utilized as a standalone intervention, as a complement to self-help psychotherapeutic methods, or for focused skills training in emotional regulation. Each level trains a specific emoion-regulation skills such as emotion recognition, relaxation, cognitive change, problem solving, compassion and self-compassion. | Behavioural | Experimental: REThink therapeutic game |
Primary outcome
Emotion regulation abilities
Time frame: baseline assessment, one week before starting the intervention
The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 -strong disagreement to 5 - strong agreement-; where higher scores represent better emotional regulation abilities. The scale has two subscales namely, emotional control ( lowest score 8 and highest 40) and emotional awareness subscales (lowest score 5, and highest 25).
Changes in emotion regulation abilities
Time frame: post-test assessment, one week after finishing the intervention
The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 -strong disagreement to 5 - strong agreement-; where higher scores represent better emotional regulation abilities. The scale has two subscales namely, emotional control ( lowest score 8 and highest 40) and emotional awareness subscales (lowest score 5, and highest 25).
Irrationality
Time frame: baseline assessment, one week before starting 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\"). The minimum score is 28 and the maximum score is 140. Higher scores represent higher levels of irrationality.
Changes in irrationality
Time frame: post-test assessment, one week after finishing 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\"). The minimum score is 28 and the maximum score is 140. Higher scores represent higher levels of irrationality.
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 25 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The REThink Game in people with Emotion Regulation Abilities, 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 3 inclusion and 3 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 25 Sep 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?
Emotion regulation abilities (time frame: baseline assessment, one week before starting the intervention). The study lists 4 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 25 Sep 2024.