Emotional ProblemNCT06529510
REThinkWELL- the Use of Therapeutic Game to Reduce Mental Health Symptoms in Children and Adolescents
A study testing REThink therpeutic game in people with Emotional Problem and Mental Health Issue, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
To test the effect of a game-based intervention in reducing clinical and subclinical symptoms of 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
- Emotional Problem, Mental Health Issue
- What is being tested?
- REThink therpeutic game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteRomania
- Study dates
- 20 May 2021to 30 Aug 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 aged 8 to 16 years
- subclinical level on the SDQ measure, total score, or emotional symptoms
- parental consent provided
Who cannot join
- intellectual disability or physical limitations precluding the use of the online game
- does not have parental informed consent
Trial locations and contacts
1 site in 1 country.
About this study
To test the effect of a game-based intervention in reducing clinical and subclinical symptoms of children and adolescents.
Read the detailed description
The general objective of the study is to test the REThink therapeutic game for improvements in clinical and subclinical mental health symptoms in children and adolescents aged 8-16 years old from multiple schools and counties. The game will be used by children and adolescents from the experimental group for a period of four weeks. Pre-test and post-test measurements will be taken.
- Conditions
- Emotional Problem, Mental Health Issue
- Being tested
- REThink therpeutic game
- Keywords
- online therapeutic game, game-based CBT, emotional problems, mental health, children and adolescents
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REThink therpeutic gameBehavioural
REThink is an online therapeutic game aimed at enhancing the emotional health of young people, grounded in Rational Emotive Behavior Therapy (REBT). The game features a character named RETMAN, who guides players through seven levels, each focused on teaching a specific emotional regulation skill. Each level has three sub-levels that progressively increase in difficulty. REThink can be used as a standalone intervention, an adjunct to self-help psychotherapeutic approaches, or for targeted skills training.
| Study group | Role | What they receive |
|---|---|---|
| REThink game | Experimental | Participants in this group will have access to the REThink therapeutic game for four weeks Receives: Behavioral: REThink therpeutic game |
| 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.
Mental health
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997). The scale has 25-items within its five subscales, namely emotional symptoms (ES), conduct problems (CP), hyperactivity/inattention (HY), peer relationship (PR) problems and prosocial behavior (PS) and total mental health difficulties score (MHD). The items are rated on a 3-point Likert scale, from 0 (not true) to 2 (certainly true). The minimum score is 0 and the maximum is 40. Higher scores represent higher level of mental health difficulties.
Measured: baseline assessment, one week prior to the intervention
Changes in mental health
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997). The scale has 25-items within its five subscales, namely emotional symptoms (ES), conduct problems (CP), hyperactivity/inattention (HY), peer relationship (PR) problems and prosocial behavior (PS) and total mental health difficulties score (MHD). The items are rated on a 3-point Likert scale, from 0 (not true) to 2 (certainly true). The minimum score is 0 and the maximum is 40. Higher scores represent higher level of mental health difficulties.
Measured: post-test assessment, one week after 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 prior to 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"). Higher scores represent higher levels of irrationality.
Measured: post-test assessment, one week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start20 May 2021
- Primary completion31 Jul 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 279 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
- NCT06529510
- Sponsor's protocol ID
- REThinkWELL
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 31 Jul 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REThinkWELL- the Use of Therapeutic Game to Reduce Mental Health Symptoms in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06529510
- Acronym / sponsor ID
- REThinkWELL
- Conditions
- Emotional Problem, Mental Health Issue
- Keywords
- online therapeutic game, game-based CBT, emotional problems, mental health, children and adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Study start
- 20 May 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 31 Jul 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 effect of a game-based intervention in reducing clinical and subclinical symptoms of children and adolescents.
Detailed description
The general objective of the study is to test the REThink therapeutic game for improvements in clinical and subclinical mental health symptoms in children and adolescents aged 8-16 years old from multiple schools and counties. The game will be used by children and adolescents from the experimental group for a period of four weeks. Pre-test and post-test measurements will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REThink game | Experimental | Behavioral: REThink therpeutic gameParticipants in this group will have access to the REThink therapeutic game for four weeks |
| 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 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children and adolescents aged 8 to 16 years
- subclinical level on the SDQ measure, total score, or emotional symptoms
- parental consent provided
Key exclusion criteria (2 listed)
- intellectual disability or physical limitations precluding the use of the online game
- does not have parental informed consent
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 therpeutic gameREThink is an online therapeutic game aimed at enhancing the emotional health of young people, grounded in Rational Emotive Behavior Therapy (REBT). The game features a character named RETMAN, who guides players through seven levels, each focused on teaching a specific emotional regulation skill. Each level has three sub-levels that progressively increase in difficulty. REThink can be used as a standalone intervention, an adjunct to self-help psychotherapeutic approaches, or for targeted skills training. | Behavioural | REThink game |
Primary outcome
Mental health
Time frame: baseline assessment, one week prior to the intervention
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997). The scale has 25-items within its five subscales, namely emotional symptoms (ES), conduct problems (CP), hyperactivity/inattention (HY), peer relationship (PR) problems and prosocial behavior (PS) and total mental health difficulties score (MHD). The items are rated on a 3-point Likert scale, from 0 (not true) to 2 (certainly true). The minimum score is 0 and the maximum is 40. Higher scores represent higher level of mental health difficulties.
Changes in mental health
Time frame: post-test assessment, one week after the intervention
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997). The scale has 25-items within its five subscales, namely emotional symptoms (ES), conduct problems (CP), hyperactivity/inattention (HY), peer relationship (PR) problems and prosocial behavior (PS) and total mental health difficulties score (MHD). The items are rated on a 3-point Likert scale, from 0 (not true) to 2 (certainly true). The minimum score is 0 and the maximum is 40. Higher scores represent higher level of mental health difficulties.
Irrationality
Time frame: baseline assessment, one week prior to 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 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"). 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 31 Jul 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 REThink therpeutic game in people with Emotional Problem and Mental Health Issue, 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 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 31 Jul 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?
Mental health (time frame: baseline assessment, one week prior to 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 31 Jul 2024.