Metacognitive Executive Function Training for Preschool Children With ADHD - A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- The executive function of preschool child of ADHD
研究概览
简要总结
The goal of this study is to provide a new, early treatment approach for preschoolers with ADHD, which could facilitate the EF developing well to achieve better outcome.
详细描述
ADHD in preschoolers has become established as a valid psychiatric disorder with characterized core deficits of executive function (EF). The EF impairments occurred in preschool period could persist to childhood, adolescent and adulthood, causing extensive and deep damage of individual's academic and career achievement, social function, and peer relationship. Psychostimulants remain a controversial opinion for preschoolers and appear less efficacious and more common side effects. It is very important to explore the effective nonpharmacological intervention targeting the EF deficits and appropriately tailored to young children. Therefore, the investigators conduct this randomized and controlled study to find out the therapeutic efficacy of metacognitive Executive Function Training for Preschool Children with ADHD (MEFP), and follow the subjects to observe whether the therapeutic efficacy would persist. In the mean time, the investigators also observe the factors which can influence the therapeutic efficacy. The goal of this study is to provide a new, early treatment approach for preschoolers with ADHD, which could facilitate the EF developing well to achieve better outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •meet both the criteria of ADHD based on the interview by the DIPA and clinical diagnosis with DSM-5;
- •full-scale IQ estimated by the Wechsler Primary and Preschool Scale of Intelligence (WPPSI) above 80;
- •their parents volunteered to participate in this study.
排除标准
- •child with severe mental disorder or physical disease that might interfere the assessment and intervention, such as Autistic Spectrum Disorder(ASD), schizophrenia, epilepsy, traumatic brain injury, etc.;
- •receive medication intervention for their ADHD symptoms before study;
- •parents with severe mental illness, such as schizophrenia, mood disorder (period of onset), etc..
研究组 & 干预措施
Intervention group
Subjects in this group will receive the "Metacognitive Executive Function Training (MEFP)" program in aiming to reduce ADHD symptoms and improve the executive function.
干预措施: Metacognitive Executive Function Training (Behavioral)
Waiting group
Subjects in this group will not receive the MEFP program during the study period.
结局指标
主要结局
The executive function of preschool child of ADHD
时间窗: through the intervention completion, an average of 8 weeks
The executive function of preschool children of ADHD assessed by neuropsychological evaluation tool NEPSY
次要结局
- The executive function in real life of preschool child of ADHD(through the intervention completion, an average of 8 weeks)
- The ADHD symptoms of child(through the intervention completion, an average of 8 weeks)
研究者
Jinsong Zhang
Director of Department of Medical Psychology, Department of Developmental Behavioral and Child Healthcare
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine