Clinical trial NCT05163938: REThink Chronic-A Mobile Therapeutic Game
Official title: REThink Chronic-A Mobile Therapeutic Game for the Prevention of Emotional Disorders Among Children Aged 8-16 Years With a Chronic Physical Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: REThink Game
Treatment-as-usual
Keywords: chronic physical disease
youth
emotional disorders
therapeutic game
prevention
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 158
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: REThink mobile therapeutic game intervention group and Treatment-as-usual group which receives the trial version of the app.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Children's emotional symptoms
timeFrame: 7 months
measure: Children's negative and positive affect
timeFrame: 7 months
Secondary outcomes:
measure: Child emotion regulation
timeFrame: 7 months
measure: Children's irrational beliefs
timeFrame: 7 months
measure: Children's quality of life
timeFrame: 7 months
measure: Emotional state
timeFrame: 7 months
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
affiliation: Babes-Bolyai University
name: Oana David, PhD
role: STUDY_DIRECTOR
References: