Treatment Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder and Developmental Delay
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change of attention
研究概览
简要总结
Using a single blind, randomized controlled design to study the additional therapeutic effects of cognitive training on traditional rehabilitation programs for children with attention deficit hyperactivity disorder and developmental delays.
详细描述
A total of 30 children with attention deficit hyperactivity disorder and developmental delays who are receiving traditional rehabilitation programs will be enrolled.
The participants will be randomized into two groups, including study group (traditional rehabilitation program with additional cognitive training: 2 times per week, 15 min per session, a total of 24 sessions) and control group (traditional rehabilitation program without additional cognitive training).
Memory related functions, quality of life, and physical function evaluations will be performed at baseline, 3 months and 6 months later, respectively.
Evaluator will be blinded to the group's classification during the whole course of study.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children diagnosed with attention deficit hyperactivity disorder with developmental delay receiving regular rehabilitation programs intelligence quotient 70 or greater
排除标准
- •age less than 4 years or elder than 8 years children diagnosed with attention deficit hyperactivity disorder receiving regular rehabilitation programs intelligence quotient less than 70
研究组 & 干预措施
study group
3 months of individualized interactive cognitive training, 2 times per week, 15 min per session, a total of 24 sessions, in addition to traditional rehabilitation programs.
干预措施: interactive cognitive training (Other)
control group
3 months of traditional rehabilitation programs, without individualized interactive cognitive training.
结局指标
主要结局
change of attention
时间窗: scores change from baseline to 3 months of treatment, and 3 months after treatment
score assessed by Swanson, Nolan and Pelham questionnaire
次要结局
- change of sensory integration(scores change from baseline to 3 months of treatment, and 3 months after treatment)
- change of intelligence(scores change from baseline to 3 months of treatment, and 3 months after treatment)
- change of health-related quality of life(changes from baseline to 3 months of treatment, and 3 months after treatment)
- change of visual motor integration(scores change from baseline to 3 months of treatment, and 3 months after treatment)
- change of functional performance(changes from baseline to 3 months of treatment, and 3 months after treatment)
研究者
Ru-Lan Hsieh
Principal investigator
Taipei Medical University