Early Socioemotional Intervention for Children With Autism Spectrum Disorder in Hong Kong and Mainland China
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
研究概览
简要总结
This study aims to develop a culturally-sensitive parent-training intervention to enhance socioemotional functioning of young children (aged 3-6) with Autism Spectrum Disorder (ASD) in Mainland China. The investigators will conduct randomized controlled trials to evaluate the effectiveness and feasibility of this program in a pilot study and then a large-scale community-based study in Shenzhen, China, to examine the generalizability of the treatment outcomes of this intervention for Chinese children with ASD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Children aged 3-6
- •Living in Shenzhen, Mainland China
- •Diagnosed with ASD or suspected of having ASD
排除标准
- 未提供
结局指标
主要结局
Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
时间窗: pre-intervention and 4-month post-intervention
ADOS-2 is a diagnostic measure used in this study to assess the change in children's ASD symptoms
Change in Dyadic Parent-Child Interaction Coding System (DPICS system)
时间窗: pre-intervention, immediately after the intervention, and 4-month post-intervention
The DPICS system is used in this study to measure the change in the quality of parent-child interaction through observations of dyads during free and structured play in the clinical setting and 5-minute parents' description of their children. The code categories include the number of command, praise, joint attention and verbal responsiveness, words used by parents and the intonation in their language.
Change in the Autism Spectrum Quotient (AQ)
时间窗: pre-intervention, immediately after the intervention, and 4-month post-intervention
AQ is a parent-report measure used in this study to measure change in children's ASD symptoms
次要结局
- Change in Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF)(pre-intervention, immediately after the intervention, and 4-month post-intervention)
- Change in Classroom Observation Scale (COS)(pre-intervention, immediately after the intervention, and 4-month post-intervention)
- Change in Self-Efficacy in Nurturing Role Questionnaire(pre-intervention, immediately after the intervention, and 4-month post-intervention)
- Change in Social Responsiveness Scale, Second Edition (SRS-2)(pre-intervention, immediately after the intervention, and 4-month post-intervention)
研究者
Professor Terry Kit-fong Au
Vice-President and Pro-Vice-Chancellor (Academic Staffing and Resources)
The University of Hong Kong