The Multi-site Study of the Early Integrated Intervention for Child Brain-developmental Disorders in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Change from baseline score of the Conners Early Childhood (Conners EC) at 1 year, 2 years for ADHD
研究概览
简要总结
This study is focused on developing the early integrated intervention for child brain-developmental disorders, including globe developmental delay (GDD), autism spectrum disorder (ASD), and attention deficit-hyperactivity disorder (ADHD), in China.
详细描述
The early integrated intervention of GDD and ASD is developed by Children's Hospital of Fudan University.
The early integrated intervention of ADHD is developed by Nanjing Brain Hospital.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GDD: IQ<70, in more than 2 areas of development;
- •ASD: Diagnose must meet the criteria of DSM-V;
- •ADHD: Diagnose must meet the criteria of DSM-V, and IQ>70 tested by Wechsler Intelligence Scale；
- •At least one of the parents could take part in the whole courses, and do the training at home.
排除标准
- •Physical disability, visual or hearing loss;
- •Combined other sever chronic diseases: liver or kidney function failure, rheumatic diseases, or tumor, and so on;
结局指标
主要结局
Change from baseline score of the Conners Early Childhood (Conners EC) at 1 year, 2 years for ADHD
时间窗: from enrollment to end of intervention (2 years). The score of Conners EC will be measured at the following time point: enrollment, 1 year, 2 years.
The Conners Early Childhood (Conners EC) aids in the early identification of behavioral, social, and emotional problems. It consists of 110 items. According to the 110 items of Conners EC, parents score children's behavioral frequency based on daily observations. The higher the score is, the more serious behavioral problems the children have. This is a repeate measurement
Change from baseline development quotient (DQ) in the Griffiths Development Scales-Chinese version at 1 year, 2 years for GDD and ASD
时间窗: from enrollment to end of intervention (2 years). The DQ will be measured at the following time point: enrollment, 1 year, 2 years.
Griffiths Development Scales-Chinese version consists of 5 subscales, which are locomotor scale, personal-social scale, eye\& hand coordination scale, hearing\& language scale. Each subscale has a development quotient. The developmental ages (DA) are referred from the norms and developmental quotients (DQ) are calculated by DA/CA (chronological age)\*100. DQ for subscales have a mean of 100 (SD: 15). Higher DQ represent a better outcome. This is a repeate measurement
次要结局
- Change from baseline score of the Communication and Symbolic Behavior Scales Developmental Profile-Infant Toddler Checklist（CSBS-DP-ITC）at 1 year, 2 years for ASD(from enrollment to end of intervention (2 years). The score of CSBS-DP-ITC will be measured at the following time point: enrollment, 1 year, 2 years.)
- Change from baseline intelligence quotient (IQ) in the Wechsler Intelligence Scale at 1 year, 2 years for ADHD(from enrollment to end of intervention (2 years). The IQ will be measured at the following time point: enrollment, 1 year, 2 years)