Emotional ProblemNCT04949620
An Integrative Platform for Promoting Children's Emotional Health
A study testing REThink therapeutic game and Online parenting program in people with Emotional Problem, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
The general objective of the study is to test an online platform for the promotion of emotional health in children Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Problem
- What is being tested?
- REThink therapeutic game and Online parenting program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteRomania
- Study dates
- 3 May 2021to 31 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged 8 to 12 years
- scores above average at any subscale of Childhood Trauma Questionnaire
- parental consent provided
- for the parental intervention: no changes in children's main outcomes following the REThink intervention
Who cannot join
- intellectual disability or physical limitations precluding the use of the online platform
- presence of a mental health disorder in the children or their enrolled parent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REThinkWELL: An Evidence-based Integrative Platform for the Prevention of Emotional Disorders in Children and Promotion of Children's Emotional Health
The general objective of the study is to test an online platform for the promotion of emotional health in children
Read the detailed description
The project aims at implementing an integrated online therapeutic platform that will be accessed by youth, parents and clinicians. The main original feature is the integration of state of the art online/mobile and gaming technologies into a unique platform that allows easy access to personalized, accessible and validated prevention.
The platform aims to allow access to attractive, easily accessible and evidence-based prevention for youths. The system will be validated in the second step as an integrative, multi-componential and adaptive platform for the prevention of emotional disorders in youth. The platform includes tools that were separately tested in laboratory conditions and found to be effective: the REThink therapeutic video game and the online REThink Parenting and Rational Parent Coach mobile programs.
- Conditions
- Emotional Problem
- Being tested
- REThink therapeutic game, Online parenting program
- Keywords
- emotional problems, children, parenting, online therapeutic game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REThink therapeutic gameBehavioural
REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention for the reduction of emotional symptoms in children and adolescents.
Online parenting programBehavioural
The online parenting intervention consists of a newly developed parenting program, including rational emotive behavioral therapy and schema therapy principles
| Study group | Role | What they receive |
|---|---|---|
| REThink game, then responder monitoring | Experimental | Participants in this group will have access to the REThink game for four weeks; based on their response to the intervention, they will be monitored for an additional period of four weeks. Receives: Behavioral: REThink therapeutic game |
| REThink game, then online parent intervention for non-responders | Experimental | Participants who are allocated to the REThink game and do not respond to the four-week intervention will be allocated to the online Receives: Behavioral: REThink therapeutic game; Behavioral: Online parenting program |
| Monitoring | No intervention | Participants in this arm will be monitored for a total of eight weeks, for comparison with the REThink game intervention (after four weeks) and the online parenting program (after an additional four weeks). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's 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: baseline
Changes in children's emotional symptoms - immediately
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: immediately post first-stage intervention (4 weeks following baseline)
Secondary outcomes (6)
Child irrationality
The Child and Adolescent Scale of Irrationality "Bernard ME, Cronan F (1999) The child and adolescent scale of irrationality: validation data and mental health correlates. J Cogn Psychother 13:121-132"
Measured: baseline
Child trauma
CTQ - Childhood Trauma Questionnaire Bernstein, D. P., Stein, J. A., Newcomb, M. D., Walker, E., Pogge, D., Ahluvalia, T., ... \& Zule, W. (2003). Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child abuse \& neglect, 27(2), 169-190.
Measured: baseline
Child behavioral difficulties
SDQ - Strengths and Difficulties Questionnaire "Goodman R, Meltzer H, Bailey V (1998) The strengths and difficulties questionnaire: "a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry 7:125-130"
Measured: baseline
Changes in child irrationality
The Child and Adolescent Scale of Irrationality "Bernard ME, Cronan F (1999) The child and adolescent scale of irrationality: validation data and mental health correlates. J Cogn Psychother 13:121-132"
Measured: immediately post first-stage intervention (4 weeks following baseline)
Changes in child behavioral difficulties
SDQ - Strengths and Difficulties Questionnaire "Goodman R, Meltzer H, Bailey V (1998) The strengths and difficulties questionnaire: "a pilot study on the validity of the self-report version. Eur Child Adolesc Psychiatry 7:125-130"
Measured: immediately post first-stage intervention (4 weeks following baseline)
Changes in children emotional abilities
The Cognitive Emotion Regulation Questionnaire - Short (Garnefski \& Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.
Measured: immediately post first-stage intervention (4 weeks following baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start3 May 2021
- Primary completion30 Aug 2022
- Study completion31 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The first stage investigates the efficacy of the online REThink therapeutic game in comparison with monitoring in the prevention of emotional disorders for 4 weeks. In the second stage, for the non-responders to the intervention, the online parenting intervention will be implemented, while the other groups will be monitored for other 4 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 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
- NCT04949620
- Sponsor's protocol ID
- 2576/ 18.03.2021
- Status last verified
- Mar 2024
- First submitted
- 11 May 2021
- Last updated
- 6 Mar 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REThinkWELL: An Evidence-based Integrative Platform for the Prevention of Emotional Disorders in Children and Promotion of Children's Emotional Health
- ClinicalTrials.gov ID
- NCT04949620
- Acronym / sponsor ID
- 2576/ 18.03.2021
- Conditions
- Emotional Problem
- Keywords
- emotional problems, children, parenting, online therapeutic game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Study start
- 3 May 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 2 Jul 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 general objective of the study is to test an online platform for the promotion of emotional health in children
Detailed description
The project aims at implementing an integrated online therapeutic platform that will be accessed by youth, parents and clinicians. The main original feature is the integration of state of the art online/mobile and gaming technologies into a unique platform that allows easy access to personalized, accessible and validated prevention.
The platform aims to allow access to attractive, easily accessible and evidence-based prevention for youths. The system will be validated in the second step as an integrative, multi-componential and adaptive platform for the prevention of emotional disorders in youth. The platform includes tools that were separately tested in laboratory conditions and found to be effective: the REThink therapeutic video game and the online REThink Parenting and Rational Parent Coach mobile programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The first stage investigates the efficacy of the online REThink therapeutic game in comparison with monitoring in the prevention of emotional disorders for 4 weeks. In the second stage, for the non-responders to the intervention, the online parenting intervention will be implemented, while the other groups will be monitored for other 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| REThink game, then responder monitoring | Experimental | Behavioral: REThink therapeutic gameParticipants in this group will have access to the REThink game for four weeks; based on their response to the intervention, they will be monitored for an additional period of four weeks. |
| REThink game, then online parent intervention for non-responders | Experimental | Behavioral: REThink therapeutic game, Behavioral: Online parenting programParticipants who are allocated to the REThink game and do not respond to the four-week intervention will be allocated to the online |
| Monitoring | No intervention | –Participants in this arm will be monitored for a total of eight weeks, for comparison with the REThink game intervention (after four weeks) and the online parenting program (after an additional four weeks). |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children aged 8 to 12 years
- scores above average at any subscale of Childhood Trauma Questionnaire
- parental consent provided
- for the parental intervention: no changes in children's main outcomes following the REThink intervention
Key exclusion criteria (2 listed)
- intellectual disability or physical limitations precluding the use of the online platform
- presence of a mental health disorder in the children or their enrolled parent
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 for the reduction of emotional symptoms in children and adolescents. | Behavioural | REThink game, then online parent intervention for non-responders, REThink game, then responder monitoring |
| Online parenting programThe online parenting intervention consists of a newly developed parenting program, including rational emotive behavioral therapy and schema therapy principles | Behavioural | REThink game, then online parent intervention for non-responders |
Primary outcome
Children's emotional symptoms
Time frame: baseline
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.
Changes in children's emotional symptoms - immediately
Time frame: immediately post first-stage intervention (4 weeks following baseline)
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.
6 secondary outcomes
Child irrationality
Time frame: baseline
Child trauma
Time frame: baseline
Child behavioral difficulties
Time frame: baseline
Changes in child irrationality
Time frame: immediately post first-stage intervention (4 weeks following baseline)
Changes in child behavioral difficulties
Time frame: immediately post first-stage intervention (4 weeks following baseline)
Changes in children emotional abilities
Time frame: immediately post first-stage intervention (4 weeks following baseline)
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 6 Mar 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 therapeutic game and Online parenting program 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 4 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 6 Mar 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?
Children's emotional symptoms (time frame: baseline). The study lists 2 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 6 Mar 2024.