Effects of Individualized Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder With 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
- changes of hyperactivity
研究概览
简要总结
Under traditional rehabilitation programs, investigate the additional effects of individualized fairytales on preschool children with Attention Deficit Hyperactivity Disorder with developmental delays.
详细描述
Thirty preschool children with Attention Deficit Hyperactivity Disorder and developmental delays will be enrolled in regular traditional rehabilitation programs.
They will be randomized to the intervention group and control group. The participants in the intervention group will receive an additional 30 minutes per week for 12 sessions of individualized fairytales classes by a child and educational teacher for three months. The participants of both groups will continue to receive the traditional rehabilitation programs.
Therapeutic effects, including attention, cognitive function, vocabulary function, physical functional performance, and quality of life at baseline, will be evaluated after 12 weeks of treatment and three months after the treatment.
The evaluator will be blinded to the group's allocation during the whole course of the intervention.
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)
盲法说明
The participants and outcome assessor will be blinded to the groups' allocation.
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preschool children with a diagnosis of Attention Deficit Hyperactivity Disorder and developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
排除标准
- •age less than 3 or greater than 6 of children diagnosed with Attention Deficit Hyperactivity Disorder and developmental delay, under regular traditional rehabilitation programs, intelligence quotient below 70
结局指标
主要结局
changes of hyperactivity
时间窗: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
score assessed by Swanson, Nolan and Pelham questionnaire, higher score indicating greater hyperactivity
changes of attention
时间窗: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
score change by Conners Kiddie Continuous Performance Test, greater score indicating lower attention span
次要结局
- change of physical functional performance(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
- change of walking time(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
- change of vocabulary(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
- change of sensory integration(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
- change of intelligence(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
- change of quality of life(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
- change of family impact(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
- change of stairs climbing time(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
- change of balance(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)
- change of physical function(score change from baseline to 12 weeks of treatment, and 12 weeks after treatment)