Cognitive Training Effects for Preschool Children With Attention Deficit Hyperactivity Disorder and Developmental Delays
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes of executive function
研究概览
简要总结
To explore whether children with Attention Deficit Hyperactivity Disorder and developmental delays who receive cognitive training and conventional rehabilitation can improve executive function more than traditional rehabilitation alone. A magnetoencephalographic examination will be arranged to explore how brain network activation works.
Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated.
详细描述
Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated, including Sensory Profile, Swanson, Nolan and Pelham version IV, Conners Kiddie Continuous Performance test, Chinese Childhood Executive Functioning Inventory, and Chinese version of Wechsler Intelligence Scale for Children-IV; and physical health conditions, including Pediatric Daily Occupation Scale, Pediatric Outcome Data Collection Instrument (PODCI), Child Health Questionnaire- Parent Form, Pediatric Quality of Life Inventory (PedsQL)will be evaluated by an investigator who is blinded to the group's allocation at before treatment and after 12 weeks of treatment. All participants will be investigated by magnetoencephalography (MEG) to identify the brain network connectivity while performing different tasks before and after 12 weeks of treatment. Brain Magnetic Resonance Imaging will be performed for brain mapping.
Possible results: The study will shed light on therapeutic effects and brain network connectivity by cognitive training for preschool children with Attention Deficit Hyperactivity Disorder and developmental delays.
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)
盲法说明
Outcome measurements will be performed by a researcher who is blind to the groups' allocation.
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under regular rehabilitation programs intelligence quotient 70 or greater
排除标准
- •age less than 4 or greater than 6 metal in teeth intelligence quotient less than 70
研究组 & 干预措施
Intervention group
Traditional rehabilitation program with additional cognitive training
干预措施: cognitive training (Other)
Active Control
Traditional rehabilitation programs without additional cognitive training
干预措施: active control (Other)
结局指标
主要结局
Changes of executive function
时间窗: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Changes in scores assessed by the Taiwanese Traditional Chinese Childhood Executive Functioning Inventory range from 1 to 5, higher scores indicate a worse outcome
次要结局
- Changes of family impact(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
- changes of symptoms of attention deficit hyperactivity disorder(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
- Changes of sensory integration(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
- Changes in performance activity in kindergarten(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
- changes of attention(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
- changes of functional performance(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
- changes of intelligence(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
- Changes of quality of life(score change from baseline to 12 weeks of treatment, higher score, the better outcome)