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Clinical Trials/NCT05163938
NCT05163938
Active, not recruiting
Not Applicable

REThink Chronic-A Mobile Therapeutic Game for the Prevention of Emotional Disorders Among Children Aged 8-16 Years With a Chronic Physical Disease

Babes-Bolyai University1 site in 1 country158 target enrollmentJanuary 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
REThink Game
Sponsor
Babes-Bolyai University
Enrollment
158
Locations
1
Primary Endpoint
Children's negative and positive affect
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The general objective of the study is to test the efficacy of an online therapeutic game (REThink Game) for the prevention of emotional disorders in children and adolescents aged between 8-16 years with a chronic physical disease.

Detailed Description

The objective of the study is to test an online therapeutic game which, being an evidence-based prevention tool for children and adolescents, might contribute to preventing emotional disorders in children and adolescents aged between 8-16 years old diagnosed with a chronic physical disease. REThink is a scientifically validated therapeutic game for children and adolescents to improve their emotional skills. The enrollment will take place both online and in pediatric medical institutions. The research study will include one parent of the eligible child/adolescent. The children and adolescents will be randomized into two equal groups: the intervention group which benefits of the entire REThink game and the treatment-as-usual group which benefits of a free trial version of the app. Three assessments will be performed to evaluate the variables of interest: before intervention (baseline), after intervention (post-intervention), and a follow-up six months after the post-intervention assessment was performed.

Registry
clinicaltrials.gov
Start Date
January 10, 2022
End Date
June 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Babes-Bolyai University
Responsible Party
Principal Investigator
Principal Investigator

Oana David

Professor

Babes-Bolyai University

Eligibility Criteria

Inclusion Criteria

  • are aged 8 to 16 years old
  • are diagnosed with a chronic physical disease
  • have consent from the parent or legal tutor to participate in the study
  • are fluent in Romanian
  • have access to a mobile phone, tablet or laptop

Exclusion Criteria

  • have intellectual disabilities or physical limitations which make it impossible for the them to play the game
  • have traumatic brain injuries
  • have a diagnosed mental disorder
  • demised during the study period

Outcomes

Primary Outcomes

Children's negative and positive affect

Time Frame: 7 months

The Positive and Negative Affect Schedule (PANAS-C; Laurent et al, 1999)

Children's emotional symptoms

Time Frame: 7 months

The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997; Goodman et al.,1998)

Secondary Outcomes

  • Children's irrational beliefs(7 months)
  • Emotional state(7 months)
  • Child emotion regulation(7 months)
  • Children's quality of life(7 months)

Study Sites (1)

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