Emotion RegulationNCT06954051
ERFs Game-based Assessment in AYAs: Validation of Game-based Assessment of Emotion Regulation Abilities
A study testing REThink Life in people with Emotion Regulation, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
This activity will have the objective of establishing the validity of in-game emotion regulation abilities assessment for adolescents and young adults. Read more about this study
- Who is it for?
- Ages 10 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- REThink Life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteRomania
- Study dates
- 15 Feb 2025to 30 Jun 2025
- 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 10 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- adolescents and young adults with between 10 and 24 years old provided with written parental consent where applicable
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: Validation of Game-based Assessment of Emotion Regulation Abilities Using the REThink Life Online Game in a Population of Adolescents and Young Adults
This activity will have the objective of establishing the validity of in-game emotion regulation abilities assessment for adolescents and young adults.
Read the detailed description
Each level of the REThink LIFE online game dedicated to training a specific ER skill has an assessment task for emotion recognition, stress reactivity, mindfulness and positive attention abilities. The aim of this study will be to investigate the validity of in-game performance measurements or scores as indicators of adolescents and young adults' emotion regulation abilities.
- Conditions
- Emotion Regulation
- Being tested
- REThink Life
- 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 LifeOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: REThink Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 Feb 2025
- Primary completion15 Jun 2025
- Study completion30 Jun 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 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 A. David, Ph.D, Principal investigator, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954051
- Sponsor's protocol ID
- REThinkRESILIENT
- Status last verified
- Aug 2025
- First submitted
- 24 Apr 2025
- Last updated
- 28 Aug 2025
- 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 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Game-based Assessment of Emotion Regulation Abilities Using the REThink Life Online Game in a Population of Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT06954051
- Acronym / sponsor ID
- REThinkRESILIENT
- Conditions
- Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 1 May 2025 (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 have the objective of establishing the validity of in-game emotion regulation abilities assessment for adolescents and young adults.
Detailed description
Each level of the REThink LIFE online game dedicated to training a specific ER skill has an assessment task for emotion recognition, stress reactivity, mindfulness and positive attention abilities. The aim of this study will be to investigate the validity of in-game performance measurements or scores as indicators of adolescents and young adults' emotion regulation abilities.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REThink Life | Other | Other: REThink LifeThe 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. |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- adolescents and young adults with between 10 and 24 years old provided with written parental consent where applicable
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 LifeREThink 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). | Other | REThink Life |
Primary outcome
Emotion regulation
Time frame: Baseline
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).
Behavioral difficulties
Time frame: Baseline
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.
Stress
Time frame: Baseline
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.
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 28 Aug 2025.
- 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 A. 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 Life 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 28 Aug 2025. 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 (time frame: Baseline). The study lists 3 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 28 Aug 2025.