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Resilience, PsychologicalNCT03308981

Efficacy of the REThink Therapeutic Online Game

A study testing REThink therapeutic online game and REBE group in people with Resilience, Psychological, run by Babes-Bolyai University at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to test the efficacy of the REThink therapeutic online video game. Children and adolescents (N = 150), aged between 10-16 years, will be randomly assigned to one of three groups: 1) REThink group, 2) Rational-Emotive-Behavioral Education (REBE) group and 3) wait-list condition. Read more about this study

Who is it for?
Ages 10 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Resilience, Psychological
What is being tested?
REThink therapeutic online game and REBE group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
1 siteRomania
Study dates
15 Sep 2016to 1 Nov 2017
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 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • aged between 10-16 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
  • Had had (in past three months) or was having psychotherapy or psychiatric treatment

Trial locations and contacts

1 site in 1 country.

Romania1 site

  • Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy

    Cluj-Napoca, 400015

Other trials in Romania

About this study

Official title: Efficacy of the REThink Therapeutic Online Game in Promoting Child and Adolescent Mental Health

This study aims to test the efficacy of the REThink therapeutic online video game. Children and adolescents (N = 150), aged between 10-16 years, will be randomly assigned to one of three groups: 1) REThink group, 2) Rational-Emotive-Behavioral Education (REBE) group and 3) wait-list condition.

Read the detailed description

Background:The prevalence of emotional disorders in children and adolescents is constantly growing and leads to long-term negative consequences for later functioning. An efficient way to approach emotional disorders in youths is to provide adequate services to them prior to the onset of symptoms. A new strategy for implementing prevention programs in youths is the use of therapeutic games. The aim of this study is to test the effectiveness of the REThink therapeutic online game,in helping children and adolescents, aged between 10-16 years, to develop psychological resilience.

Methods: To test the effectiveness of the REThink therapeutic online game, 150 children and adolescents aged between 10-16 years will be included in the study. Participants will be randomly assigned to one of three groups: 1) the online therapeutic game intervention (REThink group), 2) the control condition Rational-Emotive-Behavioral Education (REBE) group and 3) the wait-list condition. Participants in the REThink group will play the seven levels of the game, structured into seven modules. In the REBE group, participants will follow seven REBE lessons, structured based on the strategies practiced in each of the REThink level. Assessment of participants will be made before, at the middle, at the end of the intervention, and at 6 months after the intervention.

Results: It is expected that participants in the REThink group will provide significantly better results regarding primary outcomes, namely psychological adjustment and the intensity of emotions. Significant improvements are expected at post-test and follow up for the REThink group regarding secondary outcomes, emotion regulation skills, temperamental variables, anxiety in a stressful situation, problem solving skills, relaxation skills,and alpha asymmetry index, compared to wait-list condition, and similarly to the REBE group. Also, it is expected that REThink efficacy will be related to changes in irrational beliefs, and negative and positive automatic thoughts. In addition, it is expected that the REThink game will register high satisfaction with the intervention.

Conclusions: This is randomized controlled trial which aims to analyze the effectiveness of a new therapeutic game developed for children and adolescents will provide important information regarding this promising tool.

Being tested
REThink therapeutic online game, REBE group
Keywords
therapeutic online game, resilience, prevention, emotional disorders, child, adolescent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REThink therapeutic online gameDevice

    The REThink therapeutic online game has seven levels. Each level has various degrees of complexity, which increase as the player progresses in the game. The scenario of the game was developed based on the REBT model, such that it focuses on: a. identifying the emotional and behavioral reactions; b. identifying cognitive processes; c. identifying the relation between cognitive processes and emotions and behavioral reactions; d. changing irrational cognitions into rational cognitions; e. building problem solving skills; f. building relaxation skills and g. building happiness skills.

  • REBE groupOther

    In the Rational-Emotive-Behavioral Education (REBE) group participants will follow 7 modules, structured based on the strategies practiced in each of the REThink level.

Study groups in NCT03308981
Study groupRoleWhat they receive
REThink therapeutic online gameExperimentalREThink group will play twice the seven levels of the game, divided into seven modules.
Receives: Device: REThink therapeutic online game
REBE groupActive comparatorParticipants will follow 7 modules, structured based on the strategies practiced in each of the REThink level.
Receives: Other: REBE group
Wait-listNo interventionParticipants will not receive any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Emotional symptoms

    Strengths and Difficulties Questionnaire - child version (SDQ; Goodman, 1997)

    Measured: 12 months

  2. Depressed mood

    The Early Adolescent Temperament Questionnaire - Revised (EATQ-R; Ellis, 2002)

    Measured: 12 months

Secondary outcomes (4)

  1. Emotion-regulation

    The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001)

    Measured: 12 months

  2. Temperament

    The Early Adolescent Temperament Questionnaire - Revised (EATQ-R; Ellis, 2002) contains 65 questions in the self-report form and is designed to measure temperamental effortful control, affiliativeness, surgency, and negative affectivity. We will use in the present study only 4 subscales from the original questionnaire: attention, fear, inhibitory control and depressive mood.

    Measured: 12 months

  3. Negative and positive emotions

    The Functional and Dysfunctional Child Mood Scales (David \& DiGiuseppe, 2016) is used in the game having included faces of children that appear during the game levels. The scale is new and will be used cautiously since only preliminary data is available concerning its psychometrics.

    Measured: 12 months

  4. Satisfaction with the intervention

    Treatment Satisfaction Visual Analogue Scales-TS-VAS (Zecca et al., 2014)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2017
  2. Study start15 Sep 2016
  3. Primary completion1 Nov 2017
  4. Study completion1 Nov 2017

Resources

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
Model description
Participants will be randomly assigned to one of three groups: 1) REThink group, 2) Rational-Emotive-Behavioral Education (REBE) group and 3) wait-list condition.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03308981
Sponsor's protocol ID
REThink therapeutic game
Status last verified
Jan 2018
First submitted
27 Sep 2017
Last updated
18 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • David OA, Fodor LA. Are gains in emotional symptoms and emotion-regulation competencies after the REThink therapeutic game maintained in the long run? A 6-month follow-up. Eur Child Adolesc Psychiatry. 2023 Oct;32(10):1853-1862. doi: 10.1007/s00787-022-02002-w. Epub 2022 May 20.

    PubMed 35593966

  • David OA, Cardos RAI, Matu S. Is REThink therapeutic game effective in preventing emotional disorders in children and adolescents? Outcomes of a randomized clinical trial. Eur Child Adolesc Psychiatry. 2019 Jan;28(1):111-122. doi: 10.1007/s00787-018-1192-2. Epub 2018 Jul 10.

    PubMed 29992353

  • David OA, Cardos RAI, Matu S. Changes in irrational beliefs are responsible for the efficacy of the REThink therapeutic game in preventing emotional disorders in children and adolescents: mechanisms of change analysis of a randomized clinical trial. Eur Child Adolesc Psychiatry. 2019 Mar;28(3):307-318. doi: 10.1007/s00787-018-1195-z. Epub 2018 Jul 9.

    PubMed 29987559

Questions about this trial

What is this clinical trial studying?

A study testing REThink therapeutic online game and REBE group in people with Resilience, Psychological, 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 3 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 18 Jan 2018. 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?

Emotional symptoms (time frame: 12 months). 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?

On the ClinicalTrials.gov record for NCT03308981, which also lists 3 linked publications.

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 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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