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Completed

NCT Number: NCT03308981

Efficacy of the REThink Therapeutic Online Game

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.

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Key information

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy

Cluj-Napoca, 400015, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REThink therapeutic online game

Device

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.

REBE group

Other

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Collaborators

  • Romanian National Authority for Scientific Research

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 13, 2017
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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