Emotional ProblemNCT04788901
Assessment of Emotion-regulation Skills in Game-based Situations
A study testing REThink therapeutic game in people with Emotional Problem, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
The aim of the study is to investigate the validity of in-game scores as indicators for emotional regulation abilities in children and adolescence. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Problem
- What is being tested?
- REThink therapeutic game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteRomania
- Study dates
- 5 May 2021to 31 Jan 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children and adolescents between 10 and 14 years
- provided written parental consent
Who cannot join
- Intellectual disability or physical limitations precluded the use of the computer program
- Had a major mental health disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Validity of In-game Performance Measurements or Scores as Indicators of Children's Emotional Regulation Abilities
The aim of the study is to investigate the validity of in-game scores as indicators for emotional regulation abilities in children and adolescence.
- Conditions
- Emotional Problem
- Being tested
- REThink therapeutic game
- Keywords
- emotional regulation, online therapeutic game, emotional regulation assessment
- 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 therapeutic 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 |
|---|---|---|
| Online therapeutic game | Experimental | Participants in this group will have access to the evaluation module of the REThink game. Receives: Other: REThink therapeutic game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 day before the intervention)
Strengths and difficulties
Strengths and Difficulties Questionnaire - child version (SDQ; Goodman, 1997). It is a 25-item on a three-point Liker scale, from 0 "not true" to 2 "certainly true" where lower scores represent an improvement or lack of problems.
Measured: Pre-intervention (one day before the intervention)
Emotional symptoms
The Child Behavior Checklist for ages 6-18 (CBCL; Achenbach \& Rescorla, 2001) is a parent-report of child emotional and behavioral problems. Each item is rated on a 3-point Likert-style scale ranging from 0 (not true) to 2 (very true or often true). The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.
Measured: Pre-intervention (one day before the intervention)
Emotion recognition
The Emotion Awareness Questionnaire (EAQ, Rieffe et al., 2008) is a 32-item questionnaire on a three-point Liker scale, from 0 "not true" to 2 "certainly true".
Measured: Pre-intervention (one day before the intervention)
Compassion
Compassion Scale for Children (CSC, Nas \& Sak, 2020) is a 20-items scale rated on a five points Likert scale from "Never" to "Always" where higher scores means higher levels of compassion.
Measured: Pre-intervention (one day before the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start5 May 2021
- Primary completion15 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional ProblemStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788901
- Sponsor's protocol ID
- 1693/22.02.2021
- Status last verified
- Sep 2022
- First submitted
- 4 Mar 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
David OA, Tomoiaga C, Fodor LA. Gamified Assessment of the Emotion Regulation Abilities in Youth: Validation of the REThink Online System. Games Health J. 2024 Jun;13(3):184-191. doi: 10.1089/g4h.2023.0011. Epub 2024 Jan 24.
PubMed 38265781
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of In-game Performance Measurements or Scores as Indicators of Children's Emotional Regulation Abilities
- ClinicalTrials.gov ID
- NCT04788901
- Acronym / sponsor ID
- 1693/22.02.2021
- Conditions
- Emotional Problem
- Keywords
- emotional regulation, online therapeutic game, emotional regulation assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Study start
- 5 May 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 9 Mar 2021 (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.
The aim of the study is to investigate the validity of in-game scores as indicators for emotional regulation abilities in children and adolescence.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online therapeutic game | Experimental | Other: REThink therapeutic gameParticipants in this group will have access to the evaluation module of the REThink game. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children and adolescents between 10 and 14 years
- provided written parental consent
Key exclusion criteria (2 listed)
- Intellectual disability or physical limitations precluded the use of the computer program
- Had a major mental health disorder
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 therapeutic 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 | Online therapeutic game |
Primary outcome
Emotion-regulation
Time frame: Pre-intervention (one day 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,
Strengths and difficulties
Time frame: Pre-intervention (one day before the intervention)
Strengths and Difficulties Questionnaire - child version (SDQ; Goodman, 1997). It is a 25-item on a three-point Liker scale, from 0 "not true" to 2 "certainly true" where lower scores represent an improvement or lack of problems.
Emotional symptoms
Time frame: Pre-intervention (one day before the intervention)
The Child Behavior Checklist for ages 6-18 (CBCL; Achenbach \& Rescorla, 2001) is a parent-report of child emotional and behavioral problems. Each item is rated on a 3-point Likert-style scale ranging from 0 (not true) to 2 (very true or often true). The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.
Emotion recognition
Time frame: Pre-intervention (one day before the intervention)
The Emotion Awareness Questionnaire (EAQ, Rieffe et al., 2008) is a 32-item questionnaire on a three-point Liker scale, from 0 "not true" to 2 "certainly true".
Compassion
Time frame: Pre-intervention (one day before the intervention)
Compassion Scale for Children (CSC, Nas \& Sak, 2020) is a 20-items scale rated on a five points Likert scale from "Never" to "Always" where higher scores means higher levels of compassion.
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 7 Sep 2022.
- Derived from this study: PubMed 38265781David OA, Tomoiaga C, Fodor LA. Gamified Assessment of the Emotion Regulation Abilities in Youth: Validation of the REThink Online System. Games Health J. 2024 Jun;13(3):184-191. doi: 10.1089/g4h.2023.0011. Epub 2024 Jan 24.
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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 REThink therapeutic game in people with Emotional Problem, 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 2 inclusion and 2 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 7 Sep 2022. 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: Pre-intervention (one day before the intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04788901, which also lists 1 linked publication.
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 7 Sep 2022.