Clinical trial NCT03308981: Efficacy of the REThink Therapeutic Online Game
Official title: Efficacy of the REThink Therapeutic Online Game in Promoting Child and Adolescent Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience, Psychological
Keywords: therapeutic online game
resilience
prevention
emotional disorders
child
adolescent
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: Romanian National Authority for Scientific Research
First posted: 2017-10-13
Enrollment: 165
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Emotional symptoms
timeFrame: 12 months
measure: Depressed mood
timeFrame: 12 months
Secondary outcomes:
measure: Emotion-regulation
timeFrame: 12 months
measure: Temperament
timeFrame: 12 months
measure: Negative and positive emotions
timeFrame: 12 months
measure: Satisfaction with the intervention
timeFrame: 12 months
Other outcomes:
measure: Irrational beliefs
timeFrame: 12 months
measure: Automatic Thoughts
timeFrame: 12 months
measure: Anxiety in a stressful situation
timeFrame: 12 months
measure: Frontal alpha asymmetry
timeFrame: 12 months
measure: Heart rate
timeFrame: 12 months
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy
Study officials:
affiliation: Babes-Bolyai University
name: Oana A David, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.