跳至主要内容
临床试验/NCT03812068
NCT03812068Unknown不适用

The Effectiveness of a Parent-mediated Developmental Behavioral Intervention for Children With Autism Spectrum Disorder and Developmental Delay: A Randomized Controlled Trial

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年9月30日最近更新:
适应症
干预措施

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

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

Experimental

Long-distance learning program combined parent-mediated developmental behavioral intervention

干预措施: Long-distance developmental behavioral intervention (Behavioral)

Developmental behavioral intervention

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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