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CompletedNCT03308981Updated Jan 18, 2018

Efficacy of the REThink Therapeutic Online Game

An interventional study of REThink therapeutic online game and REBE group in Resilience, Psychological, sponsored by Babes-Bolyai University. Completed at 1 site in Romania. Open to participants aged 10 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-18.

Sponsored by Babes-Bolyai University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
10 Years to 16 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Resilience, Psychological

Keywords

  • therapeutic online game
  • resilience
  • prevention
  • emotional disorders
  • child
  • adolescent
03

Who can participate

Ages eligible
10 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • aged between 10-16 years
  • provided written parental consent

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
165 participants (actual)

Study arms

  • Experimental
    REThink therapeutic online game

    REThink group will play twice the seven levels of the game, divided into seven modules.

    Device: REThink therapeutic online game

  • Active comparator
    REBE group

    Participants will follow 7 modules, structured based on the strategies practiced in each of the REThink level.

    Other: REBE group

  • No intervention
    Wait-list

    Participants will not receive any intervention.

Interventions

  • DeviceREThink therapeutic online game

    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.

  • OtherREBE group

    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.

05

What researchers measure

Primary outcomes

  1. Emotional symptoms

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

    Time frame: 12 months

  2. Depressed mood

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

    Time frame: 12 months

Secondary outcomes

  1. Emotion-regulation

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 12 months

  4. Satisfaction with the intervention

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

    Time frame: 12 months

Other outcomes

  1. Irrational beliefs

    The Child and Adolescent Scale of Irrationality (CASI; Bernard \& Cronan, 1999) will be used to measure irrational cognitions in children and adolescents, a hypothesized mediating variable.

    Time frame: 12 months

  2. Automatic Thoughts

    Children's Automatic Thoughts Scale-Negative/Positive (CATS-N/P; Hogendoorn et al., 2010) is a 50-item questionnaire that assesses negative and positive automatic thoughts in children and adolescents. This variable is a hypothesized mediating variable.

    Time frame: 12 months

  3. Anxiety in a stressful situation

    The Profile of Affective Distress (PDA; Opriș \& Macavei, 2007)

    Time frame: 12 months

  4. Frontal alpha asymmetry

    EMOTIV Epoc+ (www.emotiv.com) will measure frontal brain activity at rest and during a stressful task at pre-post and follow-up.

    Time frame: 12 months

  5. Heart rate

    Polar Heart Rate Sensor (http://www.polar.com) will measure heart rate in a stressful situation pre, post and at follow-up.

    Time frame: 12 months

06

Study locations

1 site
  • Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy
    Cluj-Napoca, 400015, Romania
07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03308981
Lead sponsor
Babes-Bolyai University
Collaborators
Romanian National Authority for Scientific Research
Responsible party
Oana David (Associate Professor Oana David, Babes-Bolyai University) — Principal investigator
First posted
Oct 13, 2017
Start date
Sep 15, 2016
Primary completion
Nov 1, 2017
Completion
Nov 1, 2017
Last update
Jan 18, 2018

Study contacts

Oana A David, PhD
study director · Babes-Bolyai University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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