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【ChiCTR2000034585】World Health Organization Caregiver Skills Training (WHO-CST) Programme for Hong Kong Chinese families of young children with developmental delays or Autism Spectrum Disorders– Phase Three: evaluation of the pilot implementation

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基本信息

登记号

ChiCTR2000034585

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2020-07-11

临床申请受理号

靶点

适应症

疑似自閉症譜系障礙和發育遲緩

试验通俗题目

World Health Organization Caregiver Skills Training (WHO-CST) Programme for Hong Kong Chinese families of young children with developmental delays or Autism Spectrum Disorders– Phase Three: evaluation of the pilot implementation

试验专业题目

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

This study aimed to examine the effectiveness of the adapted WHO-CST intervention in the local settings. The specific objectives of the study are: 1) to examine the effectiveness of WHO-CST programme in Hong Kong context; 2) to examine potential factors influencing the effectiveness of WHO-CST programme in Hong Kong context

试验分类

试验类型

随机平行对照

试验分期

其它

随机化

The research team will randomly assign participants into 12 groups, as well as condition.

盲法

试验项目经费来源

Charities Trust

试验范围

目标入组人数

实际入组人数

第一例入组时间

2020-09-01

试验终止时间

2021-07-31

是否属于一致性

入选标准

The caregiver-child dyads will be recruited if they fulfilled the following inclusion criteria: For caregivers, they should be; 1. At least 18 years or above; 2. the primary caregiver who is responsible for the role of parenting the child, this could be biological parent (father or mother), guardian or other adult family member (i.e., the same caregiver who will attend the WHO-CST programme if s/he agrees); 3. living together with the target child; 4. able to communicate in Cantonese; 5. able to read and write basic Chinese; 6. planned to stay in Hong Kong for at least six months for most of the time for home visits and 9 sections of face-to-face group intervention and accessible by phone; Additionally, to ensure the adherence of WHO-CST programme, these caregivers shall allow the following procedures to be carried out during the programme implementation: 1. allow three home visits by facilitators who deliver the programme (World Health Organization, 2016). These MTs would be the professionals or para-professionals from HKU, governmental bodies and/or NGOs, and 2. agree to take videos for research purposes. The video-recording will take place on three home visits and 9 sections of face-to-face group intervention. For children, they should be: 1. between 2 and 6 years old; 2. screened positive on Chinese version of the Checklist for Autism in Toddlers (C-CHAT-23) Wong et al. (2004) or 3. suspected to display symptoms or behaviours of autism spectrum disorder, such as persistent deficits in social communication and social interaction across multiple contexts and restricted, repetitive patterns of behaviours, interest, or activities; 4. suspected to display symptoms or behaviours of communication disorder, such as persistent difficulties in the acquisition and use of language across modalities and language abilities are substantially and quantifiably below those expected age; 5. the above symptoms or behaviours are the primary concerns of developmental issues the child face as reported by caregivers or clinicians (children who are suspected to co-morbid other conditions, such as intellectual disability, attention deficit hyperactivity disorder, specific learning disorder, motor disorder are also eligible if these other conditions are not primary concerns of developmental issues).；

排除标准

Caregivers will be excluded if they fulfil the following criterion: Physical or mental condition that required hospitalization or frequent outpatient visits (e.g., three visits for 6 months). Children will be excluded if they fulfil one of the following criteria; 1. Deafness or blindness in the child; 2. Co-morbid physical and mental conditions that the child is now hospitalized; 3. Co-morbid motor skill developmental delays, physical disabilities or motor disorders, including stereotypic movement disorder, tic disorder, and other.；

研究者信息

研究负责人姓名

试验机构

Hong Kong Jockey Club Charities Trust

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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