Developmental Function and Participation in Life and School Activities in Patients With Autism Spectrum Disorder: A Follow-up Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change from baseline of body function & structures in 6 months and 12 months
研究概览
简要总结
Developmental function and Participation in life and school activities in patients with autism spectrum disorder: A follow-up study
详细描述
Most ASD studies have explored the body functions and core symptoms in children with ASD by follow-up, but less studies explore the activities and participation by follow-up, especially the changes in different ages. Although studies explore many predictors to predict the activities and participation in children with ASD, but less studies explore sensory perception to predict the activities and participation in children with ASD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Autism Spectrum Disorder
- •Age 2-18 y/o
- •Agree to sign informed consent
排除标准
- •Active medical condition (e.g. infection)
- •Concurrent progressive or degenerative disease (e.g. neurogenerative disease)
- •Concurrent illness or disease not typically associated with ASD (e.g. pneumonia)
结局指标
主要结局
Change from baseline of body function & structures in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
Bruininks- Oseretsky Test of Motor Proficiency II short form
Change from baseline of Participation in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
Preferences for Activity of Children(APCP): For children between the ages of two and five, the questionnaire model is used to allow parents to circle the level. There are 45 questions in total, so that the case or parent can review the activities in the past 4 months and ask if the child have done this activity (1 point means yes, 0 points means no).
Change from baseline of Visual Perception in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
Test of Visual Perceptual Skills-Third Edition
Change from baseline of general developmental for Healthy child and patients with Autism Spectrum Disorder in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
Comprehensive Developmental Inventory for Infants and Toddlers
Change from baseline of Sensory and Perceptual function in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
Sensory Profile:It is composed of 125 projects and is completed by the main caregivers of children. There are 14 sub-projects, which can be divided into three main areas: sensory processing (6 items), adjustment (5 items), and emotional response ( 3 items), the project score is divided into 0, 25, 50, 75, 100% (none, rarely, occasionally, often, almost always)
次要结局
- Change from baseline of Quality of Life in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Personal & Environment factor in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Social Responsiveness Scale in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of facial expression in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Clancy Behavior Scale in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Theory of Mind Inventory-2 in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Childhood Autism Rating Scale II in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Rehabilitation & community service factor in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of lower extremity function & structures in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of activities in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Childhood Asperger Syndrome Test in 6 months and 12 months(baseline, 6 months, 12 months)