Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Adolescents With Attention-Deficit/Hyperactivity Disorder and Emotion Dysregulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Emotion dysregulation severity
研究概览
简要总结
To assess the effectiveness and security of a mobile App (beta version) for self-managing emotion dysregulation in a pragmatic randomized controlled trial with 80 adolescents with attention-deficit/hyperactivity disorder comparing 40 patients with treatment as usual (TAU) with 40 patients with TAU plus the mobile App
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of attention-deficit/hyperactivity disorder
- •High emotion dysregulation severity
- •Aged 14 to 17 years
- •Outpatient setting (Consorci Sanitari del Maresme
排除标准
- •Comorbidity with mental retardation
- •Comorbidity with psychotic disorder
- •Comorbidity with autism spectrum disorder
结局指标
主要结局
Emotion dysregulation severity
时间窗: 9 months
Severity of emotional dysregulation as measured by a single score from the The DERS (Difficulties in Emotion Regulation Scale) (range: 0-88; the higher the score, the more severe the emotion dysregulation severity).
Smartphone addiction
时间窗: 9.months
Severity of smartphone addiction as measured by the Spanish version of the The Smartphone Addiction Scale (SAS) (range: 10-60; the higher the score, the more severe the smartphone addiction severity).
次要结局
未报告次要终点