Efficacy of the REThink Therapeutic Online Game

Resilience, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308981
• Other study ID #: REThink therapeutic game
• Status: Completed
• Phase: N/A
• First received: September 27, 2017
• Last updated: January 17, 2018
• Start date: September 15, 2016
• Est. completion date: November 1, 2017

Study information

• Verified date: January 2018
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Resilience, Psychological

Intervention

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.

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.

Locations

Country	Name	City	State
Romania	Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy	Cluj-Napoca

Sponsors (2)

Lead Sponsor	Collaborator
Babes-Bolyai University	Romanian National Authority for Scientific Research

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 months
Other	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.	12 months
Other	Anxiety in a stressful situation	The Profile of Affective Distress (PDA; Opri? & Macavei, 2007)	12 months
Other	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.	12 months
Other	Heart rate	Polar Heart Rate Sensor (http://www.polar.com) will measure heart rate in a stressful situation pre, post and at follow-up.	12 months
Primary	Emotional symptoms	Strengths and Difficulties Questionnaire - child version (SDQ; Goodman, 1997)	12 months
Primary	Depressed mood	The Early Adolescent Temperament Questionnaire - Revised (EATQ-R; Ellis, 2002)	12 months
Secondary	Emotion-regulation	The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker & Easterbrooks, 2001)	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	Satisfaction with the intervention	Treatment Satisfaction Visual Analogue Scales-TS-VAS (Zecca et al., 2014)	12 months