The Effectiveness of a Parent-mediated Developmental Behavioral Intervention for Children With Autism Spectrum Disorder and Developmental Delay: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Peabody Developmental Motor Scales, Second Edition
研究概览
简要总结
This study explores the effectiveness of two intervention programs: "Long-distance developmental behavioral intervention" and "developmental behavioral interventions" for children with autism spectrum disorder or multiple 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)
入排标准
- 年龄范围
- 30 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child's age between 30-84 months old.
- •Children have a diagnosis of autism spectrum disorder or multiple developmental delays.
- •Children without physical disabilities or major health problems, such as congenital limb defects.
- •One of the fathers or mothers involved in the study shall be the primary caregiver of the child.
- •The father or mother participating in the study has at least 9 education years and can read and understand Chinese.
- •The father or mother participating in the study is willing to allow the child to undergo a comprehensive development assessment and is willing to video during the training process.
排除标准
- •Absence of chromosome abnormalities, congenital anomalies, and major neurological or sensory impairments or disorders (e.g., cerebral palsy, microcephalus, macrocephalus, severe brain damage, uncorrected vision, or hearing loss).
研究组 & 干预措施
Long-distance developmental behavioral intervention
Long-distance learning program combined parent-mediated developmental behavioral intervention
干预措施: Long-distance developmental behavioral intervention (Behavioral)
Developmental behavioral intervention
only parent-mediated developmental behavioral intervention
干预措施: Developmental behavioral intervention (Behavioral)
结局指标
主要结局
Peabody Developmental Motor Scales, Second Edition
时间窗: 3 months
measurement of multiple fine and gross motor functions
The Autism Diagnostic Observation Schedule
时间窗: 3 months
measurement of autism status and severity level
Child Behavior Checklist Ages 1.5-5
时间窗: 3 months
measurement of child's behavioral syndrome and problems
3D Gait Assessment Foot-worn Inertial Sensor
时间窗: 3 months
measurement of gait performance
Pediatric Evaluation of Disability Inventory
时间窗: 3 months
measurement of child's daily living function
Movement Assessment Battery for Children
时间窗: 3 months
measurement of child's motor coordination
Mullen Scale of Early Learning
时间窗: 3 months
measurement of child's cognitive and motor development
次要结局
- Parenting Sense of Competence Scale(3 months)
- Parenting Stress Index(3 months)