Emotional ProblemNCT05424900
An Integrative Intervention for Preventing Children's Emotional Disorders
A study testing Rethink game in people with Emotional Problem, run by Oana David at 1 site in Romania.
Trial summary
The general objective of the study is to test an online platform for the prevention of emotional disorders in children aged 8-12 without any clinical symptoms. 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 game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteRomania
- Study dates
- 3 May 2021to 30 Sep 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
- parental consent provided
- al least one answer different than never true on the Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein \& Fink, 1998; Bernstein et al., 2003), measuring dichotomically the presence of Emotional Neglect, Physical Neglect, Emotional Abuse, Physical Abuse
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
The general objective of the study is to test an online platform for the prevention of emotional disorders in children aged 8-12 without any clinical symptoms.
Read the detailed description
The general objective of the study is to test an online platform for the prevention of emotional disorders in children aged 8-12 without any clinical symptoms. The game will be used by children and adolescents for a period of four weeks. Pre-test and post-test measurements will be taken.
- Conditions
- Emotional Problem
- Being tested
- Rethink game
- Keywords
- online therapeutic game, emotional problems, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rethink 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.
| Study group | Role | What they receive |
|---|---|---|
| REThink game | Experimental | 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. Receives: Behavioral: Rethink game |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child emotion regulation
The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilitie
Measured: baseline; pre-intervention (one week before the intervention)
Changes in child emotion regulation
The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities.
Measured: post-test, one week after the intervention
Children emotional regulation
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: baseline; pre-intervention (one week before the intervention)
Changes in children emotional regulation
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: post-test, one week after the intervention
child emotional simptoms
SDQ - Strengths and Difficulties Questionnaire "Goodman R, Meltzer H, Bailey V (1998)
Measured: baseline; pre-intervention (one week before the intervention)
Changes in child emotional simptoms
SDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998)
Measured: post-test, one week after the intervention
Secondary outcomes (5)
Children's irrational beliefs
The Child and Adolescent Scale of Irrationality (CASI, Bernard \& Cronan, 1999)
Measured: baseline; pre-intervention (one week before the intervention)
changes in Children's irrational beliefs
The Child and Adolescent Scale of Irrationality (CASI, Bernard \& Cronan, 1999)
Measured: post-test, one week after the intervention
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; pre-intervention (one week before the intervention)
Mental health
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; pre-intervention (one week before the intervention)
Changes child mental health
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: post-test, 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 posted21 Jun 2022
- Study start3 May 2021
- Primary completion15 Sep 2022
- Study completion30 Sep 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oana David
- Sponsor type
- University, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Responsible party
- Sponsor-investigator, Oana David, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424900
- Sponsor's protocol ID
- REThink Preventive
- Status last verified
- Oct 2023
- First submitted
- 15 Jun 2022
- Last updated
- 5 Oct 2023
- 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 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrative Intervention for Preventing Children's Emotional Disorders
- ClinicalTrials.gov ID
- NCT05424900
- Acronym / sponsor ID
- REThink Preventive
- Conditions
- Emotional Problem
- Keywords
- online therapeutic game, emotional problems, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Oana DavidUniversity, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Study start
- 3 May 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 21 Jun 2022 (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 prevention of emotional disorders in children aged 8-12 without any clinical symptoms.
Detailed description
The general objective of the study is to test an online platform for the prevention of emotional disorders in children aged 8-12 without any clinical symptoms. The game will be used by children and adolescents for a period of four weeks. Pre-test and post-test measurements will be taken.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REThink game | Experimental | Behavioral: Rethink 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. |
| 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). |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged 8 to 12 years
- parental consent provided
- al least one answer different than never true on the Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein \& Fink, 1998; Bernstein et al., 2003), measuring dichotomically the presence of Emotional Neglect, Physical Neglect, Emotional Abuse, Physical Abuse
Key exclusion criteria (1 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 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 |
Primary outcome
Child emotion regulation
Time frame: baseline; pre-intervention (one week before the intervention)
The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilitie
Changes in child emotion regulation
Time frame: post-test, one week after the intervention
The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities.
Children emotional regulation
Time frame: baseline; pre-intervention (one week before the intervention)
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.
Changes in children emotional regulation
Time frame: post-test, one week after the intervention
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.
child emotional simptoms
Time frame: baseline; pre-intervention (one week before the intervention)
SDQ - Strengths and Difficulties Questionnaire "Goodman R, Meltzer H, Bailey V (1998)
Changes in child emotional simptoms
Time frame: post-test, one week after the intervention
SDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998)
5 secondary outcomes
Children's irrational beliefs
Time frame: baseline; pre-intervention (one week before the intervention)
changes in Children's irrational beliefs
Time frame: post-test, one week after the intervention
child behavioral difficulties
Time frame: baseline; pre-intervention (one week before the intervention)
Mental health
Time frame: baseline; pre-intervention (one week before the intervention)
Changes child mental health
Time frame: post-test, one week after the intervention
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 5 Oct 2023.
- 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 game in people with Emotional Problem, run by Oana David 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 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 5 Oct 2023. 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?
Child emotion regulation (time frame: baseline; pre-intervention (one week before the intervention)). The study lists 6 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 5 Oct 2023.