A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With Attention Deficit Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- total score change in SNAP-IV scale
研究概览
简要总结
This study is designed to test if the medical-education-community collaborated intervention can reduce the symptoms of children with Attention deficit hyperactivity disorder (ADHD) compared to routine clinical care. Investigators will also evaluate if the intervention will positively affect organizational skills and academic achievement compared to controls.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The medical treatment of participants will be given by a doctor who does not know the study group of the patient. The investigator of the primary outcome and secondary outcome will also be unaware of the grouping of the patient. One psychiatrist blind of grouping will ask parents about the ADHD symptom of their children and rate it with SNAP-IV score.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ADHD
- •Doctor rated SNAP-IV Inattention of Hyperactivity/Impulsivity score>12
- •Full-Scale Intelligence Quotient>=80 (Wechsler intelligence scale for children-IV)
排除标准
- •Accepting any type of psychological treatment during the intervention
- •Comorbid with epileptic disorder or other existing physical disorder, Tourette syndrome, Autism Spectrum Disorder, learning disorder, mood disorder, psychiatric disorder, or under suicidal risk
- •Attending any other clinical research at the same time
研究组 & 干预措施
Medical-education-community Collaborated Intervention
干预措施: Medical-education-community Collaborated Intervention (Behavioral)
routine clinical care
干预措施: routine clinical care (Behavioral)
结局指标
主要结局
total score change in SNAP-IV scale
时间窗: Baseline, 3 months after enrollment
It is a repeated measurement. The Swanson, Nolan, and Pelham Questionnaire (SNAP-IV) Rating Scale is a revised version of the Swanson, Nolan and Pelham (SNAP) Questionnaire that utilizes the DSM-IV criteria for ADHD and oppositional defiant disorder, rated by caregiver or professionals. It comprises three subscales: Inattention, Hyperactivity/Impulsivity, and Oppositional Defiant Disorder. The score of each item is rated with a 4-point Likert scale (0 = not at all, 3 = very much). We choose the total score ofInattention and Hyperactivity/Impulsivityfor the evaluation of change in ADHD symptom in children. The score is calculated by adding all the items inthe two subscales. The change of score is calculated by score at 3 months enrollment minus score at baseline (enrollment).
次要结局
- total score change in Behavior Rating Inventory of Executive Function scale(Baseline, 3 months after enrollment)