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Efficacy of the REThink Therapeutic Online Game

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ClinicalTrials.gov Identifier: NCT03308981
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Romanian National Authority for Scientific Research
Information provided by (Responsible Party):
Oana David, Babes-Bolyai University

Brief 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.

Condition or disease Intervention/treatment Phase
Resilience, Psychological Device: REThink therapeutic online game Other: REBE group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of the REThink Therapeutic Online Game in Promoting Child and Adolescent Mental Health
Actual Study Start Date : September 15, 2016
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Arm Intervention/treatment
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
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.

Active Comparator: REBE group
Participants will follow 7 modules, structured based on the strategies practiced in each of the REThink level.
Other: REBE 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.

No Intervention: Wait-list
Participants will not receive any intervention.



Primary Outcome Measures :
  1. Emotional symptoms [ Time Frame: 12 months ]
    Strengths and Difficulties Questionnaire - child version (SDQ; Goodman, 1997)

  2. Depressed mood [ Time Frame: 12 months ]
    The Early Adolescent Temperament Questionnaire - Revised (EATQ-R; Ellis, 2002)


Secondary Outcome Measures :
  1. Emotion-regulation [ Time Frame: 12 months ]
    The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker & Easterbrooks, 2001)

  2. Temperament [ Time Frame: 12 months ]
    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.

  3. Negative and positive emotions [ Time Frame: 12 months ]
    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.

  4. Satisfaction with the intervention [ Time Frame: 12 months ]
    Treatment Satisfaction Visual Analogue Scales-TS-VAS (Zecca et al., 2014)


Other Outcome Measures:
  1. Irrational beliefs [ Time Frame: 12 months ]
    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.

  2. Automatic Thoughts [ Time Frame: 12 months ]
    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.

  3. Anxiety in a stressful situation [ Time Frame: 12 months ]
    The Profile of Affective Distress (PDA; Opriș & Macavei, 2007)

  4. Frontal alpha asymmetry [ Time Frame: 12 months ]
    EMOTIV Epoc+ (www.emotiv.com) will measure frontal brain activity at rest and during a stressful task at pre-post and follow-up.

  5. Heart rate [ Time Frame: 12 months ]
    Polar Heart Rate Sensor (http://www.polar.com) will measure heart rate in a stressful situation pre, post and at follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308981


Locations
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Romania
Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy
Cluj-Napoca, Romania, 400015
Sponsors and Collaborators
Babes-Bolyai University
Romanian National Authority for Scientific Research
Investigators
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Study Director: Oana A David, PhD Babes-Bolyai University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oana David, Associate Professor Oana David, Babes-Bolyai University
ClinicalTrials.gov Identifier: NCT03308981    
Other Study ID Numbers: REThink therapeutic game
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oana David, Babes-Bolyai University:
therapeutic online game
resilience
prevention
emotional disorders
child
adolescent