Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03308981
Other study ID # REThink therapeutic game
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03270943 - The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens N/A
Terminated NCT04970641 - Three Good Things (3GT) - Intervention for Transitional Care Patients N/A
Not yet recruiting NCT06061965 - Facilitating Advance Care Planning Discussions for People With Advance Cancer N/A
Active, not recruiting NCT05293431 - Promote Brain Resilience for the Coronavirus (COVID-19) Pandemic N/A
Recruiting NCT05072340 - Evaluation of Resilience Skills Enhancement (RISE) Training Among University Students N/A
Recruiting NCT05094115 - Enhancing Resiliency and Optimizing Readiness in Military Personnel N/A
Completed NCT03673098 - The BRIgHT Program: Building Resilience in HIV Together N/A
Active, not recruiting NCT05719129 - The Lasting Change Study
Completed NCT03071887 - Resilience Intervention for Older, HIV-Infected Women N/A
Recruiting NCT05130879 - Building Resilience @ Work Training Among Healthcare Workers N/A
Active, not recruiting NCT03705208 - Youth First: A Longitudinal Impact Evaluation N/A
Completed NCT05703529 - Group-based Positive Psychotherapy in Psychological Resilience of Only-Child-Lost People N/A
Completed NCT02603133 - Web-based Implementation for the Science of Enhancing Resilience Study N/A
Completed NCT05133115 - Fostering Resilience in Adolescents at Risk. N/A
Recruiting NCT04935710 - Prevention and Early Identification for High Risk Youth in School-based Clinics Phase 1
Completed NCT04231604 - Evaluation of a School-based Programme Aimed at Promoting Well-being in Adolescents N/A
Enrolling by invitation NCT06021236 - Efficacy of a Mindfulness-Based Intervention in Patients With Cardiovascular Implantable Electronic Device N/A
Active, not recruiting NCT05648045 - Resilience and Obesity Prevention in Adolescents
Recruiting NCT03458936 - Resilience in Adolescent Development
Completed NCT05154565 - Effect of a Daily Meditation Intervention in Student Pharmacists N/A