REThink Chronic-A Mobile Therapeutic Game for the Prevention of Emotional Disorders Among Children Aged 8-16 Years With a Chronic Physical Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Children's negative and positive affect
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Children's negative and positive affect
时间窗: 7 months
The Positive and Negative Affect Schedule (PANAS-C; Laurent et al, 1999)
Children's emotional symptoms
时间窗: 7 months
The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997; Goodman et al.,1998)
次要结局
- Children's irrational beliefs(7 months)
- Emotional state(7 months)
- Child emotion regulation(7 months)
- Children's quality of life(7 months)
研究者
Oana David
Professor
Babes-Bolyai University