Bullying of ChildREThinkNCT06646159
REThink for Mental Health of the Youths in Romania
A study testing REThink Intervention in people with Bullying of Child and Bullying Victimisation, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
In order to test the effect of the intervention, a multi-center randomized control trial (RCT) will be conducted to test the efficacy of the REThink interventions on improving bullying (both victimization and aggression) and mental health compared with a care as usual group. Read more about this study
- Who is it for?
- Ages 10 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Bullying of Child, Bullying Victimisation, Bullying
- What is being tested?
- REThink Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteRomania
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- internet and PC access to complete the scales and game
Who cannot join
- no internet or PC access
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site
Babes-Bolyai University
Cluj-Napoca, 400015
Cristina Tomoiaga, 0751696209, cristinalorint@psychology.ro
About this study
In order to test the effect of the intervention, a multi-center randomized control trial (RCT) will be conducted to test the efficacy of the REThink interventions on improving bullying (both victimization and aggression) and mental health compared with a care as usual group. A minimum of 1000 students from the participating institutions (schools will be able to join based on a recruitment call), will be recruited and randomly assigned to either the experimental or control group.
- Conditions
- Bullying of Child, Bullying Victimisation, Bullying
- Being tested
- REThink Intervention
- Medical subject headings
- Bullying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REThink InterventionBehavioural
At its core, the REThink game consists of seven levels, each focusing on a specific emotion-regulation skill crucial for emotional health. The game's story is based on the RETMAN character which helps the player fight the power of the "Irrationalizer" who personalizes irrational beliefs. The game is based on cognitive-behavioral psychotherapy - the unified protocol (Barlow et al., 2004) and well-supported Rational Emotive Behavioral Therapy (Ellis, 1995). Each level is composed of three sublevels, increasing in difficulty, and also has an embedded validated assessment system (composed of a sublevel for each level; David, Tomoiaga \& Fodor, 2024), and can function as a standalone intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: REThink | Experimental | To ensure age-appropriate interventions, students below the age of 18 in the experimental group will receive the REThink game, while college-aged participants will engage with the REThink LIFE game. Receives: Behavioral: REThink Intervention |
| Control | No intervention | The students randomized in the control group will access the intervention after finalizing the post-test measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bullying
Bullying and Cyberbullying Scale for Adolescents will be used to measure bullying. The scale is composed of 26 items, the minimum score is 26 and the maximum 130. Higher scores represent higher levels of bullying
Measured: baseline assessment, one week before starting the intervention
Mental Health
Depression, Anxiety, and Stress Scale is used for mental healh. For this scale, lower scores represent lower levels of anxiety, depression and stress, the minimum score is 0 and maximum score is 63.
Measured: baseline assessment, one week before starting the intervention
Mental Health Stigma
The Stigma Scale measures mental health stigma. Lower scores represent an improvement. The minimum score is 9, and the maximum is 45.
Measured: baseline assessment, one week before starting the intervention
Stress
MoodWheel instrumentis used to measure stress. The scale is composed of 32 items representing emotions which are divided into four subscales: positive functional emotions, positive dysfunctional emotions, negative functional and negative dysfunctional emotions. Scores at each subscale represent higher levels of that category of emotion.The minimum score is 0 and the maximum is 160
Measured: baseline assessment, one week before starting the intervention
Self-compassion
The Self-Compassion Scale Short Form is used to measure self-compassion. The scale has two dimensions, namely Self-Care, where higher scores represent higher levels of self-care, and Self-Disparagement, where lower scores represent an improvement.The minim score is 12 and the maximum is 60.
Measured: baseline assessment, one week before starting the intervention
Compassion
Compassion Scale for children is a valid and reliable measurement tool that will be able to determine the level of compassion of children between the ages of 10 to 18-year-olds.The minimum score is 9, and maximum is 54.
Measured: baseline assessment, one week before starting the intervention
Emotion regulation
The in-game assessment for each REThink intervention. This assessment system is the trial version of the game with sections for each level and very good psychometric properties. For this system, higher scores represent higher levels of various emotion-regulation abilities.
Measured: baseline assessment, one week before starting the intervention
Trauma Screening
Childhood Trauma Screener is used to measure past traumatic experiences .The scale is composed of 5 items each representing a type of trauma or abuse. Higher scores represent higher frequency of abuse and/or trauma. The minimum score is and the maximum score is 5 and the maximum 25.
Measured: baseline assessment, one week before starting the intervention
Changes in bullying
Bullying and Cyberbullying Scale for Adolescents will be used to measure bullying. The scale is composed of 26 items, the minimum score is 26 and the maximum 130. Higher scores represent higher levels of bullying
Measured: post-test assessment, one week after finishing the intervention
Changes in mental health
Depression, Anxiety, and Stress Scale is used for mental healh. For this scale, lower scores represent lower levels of anxiety, depression and stress, the minimum score is 0 and maximum score is 63.
Measured: post-test assessment, one week after finishing the intervention
Changes in mental health stigma
The Stigma Scale measures mental health stigma. Lower scores represent an improvement. The minimum score is 9, and the maximum is 45.
Measured: post-test assessment, one week after finishing the intervention
Changes in stress
MoodWheel instrumentis used to measure stress. The scale is composed of 32 items representing emotions which are divided into four subscales: positive functional emotions, positive dysfunctional emotions, negative functional and negative dysfunctional emotions. Scores at each subscale represent higher levels of that category of emotion.The minimum score is 0 and the maximum is 160
Measured: post-test assessment, one week after finishing the intervention
Changes in self-compassion
The Self-Compassion Scale Short Form is used to measure self-compassion. The scale has two dimensions, namely Self-Care, where higher scores represent higher levels of self-care, and Self-Disparagement, where lower scores represent an improvement.The minim score is 12 and the maximum is 60.
Measured: post-test assessment, one week after finishing the intervention
Changes in compassion
Compassion Scale for children is a valid and reliable measurement tool that will be able to determine the level of compassion of children between the ages of 10 to 18-year-olds.The minimum score is 9, and maximum is 54.
Measured: post-test assessment, one week after finishing the intervention
Changes in emotion regulation
The in-game assessment for each REThink intervention. This assessment system is the trial version of the game with sections for each level and very good psychometric properties. For this system, higher scores represent higher levels of various emotion-regulation abilities.
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 posted17 Oct 2024
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullying of ChildStudies 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
- 1,000 participants (estimated)
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
- NCT06646159
- Sponsor's protocol ID
- REThinkBullying
- Acronym
- REThink
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REThink for Mental Health of the Youths in Romania
- ClinicalTrials.gov ID
- NCT06646159
- Acronym / sponsor ID
- REThink / REThinkBullying
- Conditions
- Bullying of Child, Bullying Victimisation, Bullying
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Oct 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.
In order to test the effect of the intervention, a multi-center randomized control trial (RCT) will be conducted to test the efficacy of the REThink interventions on improving bullying (both victimization and aggression) and mental health compared with a care as usual group. A minimum of 1000 students from the participating institutions (schools will be able to join based on a recruitment call), will be recruited and randomly assigned to either the experimental or control 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 | Experimental | Behavioral: REThink InterventionTo ensure age-appropriate interventions, students below the age of 18 in the experimental group will receive the REThink game, while college-aged participants will engage with the REThink LIFE game. |
| Control | No intervention | –The students randomized in the control group will access the intervention after finalizing the post-test measurement |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- internet and PC access to complete the scales and game
Key exclusion criteria (1 listed)
- no internet or PC access
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 InterventionAt its core, the REThink game consists of seven levels, each focusing on a specific emotion-regulation skill crucial for emotional health. The game's story is based on the RETMAN character which helps the player fight the power of the "Irrationalizer" who personalizes irrational beliefs. The game is based on cognitive-behavioral psychotherapy - the unified protocol (Barlow et al., 2004) and well-supported Rational Emotive Behavioral Therapy (Ellis, 1995). Each level is composed of three sublevels, increasing in difficulty, and also has an embedded validated assessment system (composed of a sublevel for each level; David, Tomoiaga \& Fodor, 2024), and can function as a standalone intervention. | Behavioural | Experimental: REThink |
Primary outcome
Bullying
Time frame: baseline assessment, one week before starting the intervention
Bullying and Cyberbullying Scale for Adolescents will be used to measure bullying. The scale is composed of 26 items, the minimum score is 26 and the maximum 130. Higher scores represent higher levels of bullying
Mental Health
Time frame: baseline assessment, one week before starting the intervention
Depression, Anxiety, and Stress Scale is used for mental healh. For this scale, lower scores represent lower levels of anxiety, depression and stress, the minimum score is 0 and maximum score is 63.
Mental Health Stigma
Time frame: baseline assessment, one week before starting the intervention
The Stigma Scale measures mental health stigma. Lower scores represent an improvement. The minimum score is 9, and the maximum is 45.
Stress
Time frame: baseline assessment, one week before starting the intervention
MoodWheel instrumentis used to measure stress. The scale is composed of 32 items representing emotions which are divided into four subscales: positive functional emotions, positive dysfunctional emotions, negative functional and negative dysfunctional emotions. Scores at each subscale represent higher levels of that category of emotion.The minimum score is 0 and the maximum is 160
Self-compassion
Time frame: baseline assessment, one week before starting the intervention
The Self-Compassion Scale Short Form is used to measure self-compassion. The scale has two dimensions, namely Self-Care, where higher scores represent higher levels of self-care, and Self-Disparagement, where lower scores represent an improvement.The minim score is 12 and the maximum is 60.
Compassion
Time frame: baseline assessment, one week before starting the intervention
Compassion Scale for children is a valid and reliable measurement tool that will be able to determine the level of compassion of children between the ages of 10 to 18-year-olds.The minimum score is 9, and maximum is 54.
Emotion regulation
Time frame: baseline assessment, one week before starting the intervention
The in-game assessment for each REThink intervention. This assessment system is the trial version of the game with sections for each level and very good psychometric properties. For this system, higher scores represent higher levels of various emotion-regulation abilities.
Trauma Screening
Time frame: baseline assessment, one week before starting the intervention
Childhood Trauma Screener is used to measure past traumatic experiences .The scale is composed of 5 items each representing a type of trauma or abuse. Higher scores represent higher frequency of abuse and/or trauma. The minimum score is and the maximum score is 5 and the maximum 25.
Changes in bullying
Time frame: post-test assessment, one week after finishing the intervention
Bullying and Cyberbullying Scale for Adolescents will be used to measure bullying. The scale is composed of 26 items, the minimum score is 26 and the maximum 130. Higher scores represent higher levels of bullying
Changes in mental health
Time frame: post-test assessment, one week after finishing the intervention
Depression, Anxiety, and Stress Scale is used for mental healh. For this scale, lower scores represent lower levels of anxiety, depression and stress, the minimum score is 0 and maximum score is 63.
Changes in mental health stigma
Time frame: post-test assessment, one week after finishing the intervention
The Stigma Scale measures mental health stigma. Lower scores represent an improvement. The minimum score is 9, and the maximum is 45.
Changes in stress
Time frame: post-test assessment, one week after finishing the intervention
MoodWheel instrumentis used to measure stress. The scale is composed of 32 items representing emotions which are divided into four subscales: positive functional emotions, positive dysfunctional emotions, negative functional and negative dysfunctional emotions. Scores at each subscale represent higher levels of that category of emotion.The minimum score is 0 and the maximum is 160
Changes in self-compassion
Time frame: post-test assessment, one week after finishing the intervention
The Self-Compassion Scale Short Form is used to measure self-compassion. The scale has two dimensions, namely Self-Care, where higher scores represent higher levels of self-care, and Self-Disparagement, where lower scores represent an improvement.The minim score is 12 and the maximum is 60.
Changes in compassion
Time frame: post-test assessment, one week after finishing the intervention
Compassion Scale for children is a valid and reliable measurement tool that will be able to determine the level of compassion of children between the ages of 10 to 18-year-olds.The minimum score is 9, and maximum is 54.
Changes in emotion regulation
Time frame: post-test assessment, one week after finishing the intervention
The in-game assessment for each REThink intervention. This assessment system is the trial version of the game with sections for each level and very good psychometric properties. For this system, higher scores represent higher levels of various emotion-regulation abilities.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Intervention in people with Bullying of Child and Bullying Victimisation, 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: opening soon, as of the sponsor's last update on 18 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oana David, Professor (+40-264-434141, oanadavid@psychology.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bullying (time frame: baseline assessment, one week before starting the intervention). The study lists 15 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 18 Oct 2024.