Today is 2020-12-01

Online multicomponent health intervention to support children with special education needs (SEN) and their families during COVID-19 pandemic
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注册号:

Registration number:

ChiCTR2000038827 

最近更新日期:

Date of Last Refreshed on:

2020-10-05 

注册时间:

Date of Registration:

2020-10-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Online multicomponent health intervention to support children with special education needs (SEN) and their families during COVID-19 pandemic  

Public title:

Online multicomponent health intervention to support children with special education needs (SEN) and their families during COVID-19 pandemic  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Online multicomponent health intervention to support children with special education needs (SEN) and their families during COVID-19 pandemic  

Scientific title:

Online multicomponent health intervention to support children with special education needs (SEN) and their families during COVID-19 pandemic  

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

Yuk Fai Ryan Ho 

研究负责人:

Prof. Eric Lee Kam Pui 

Applicant:

Yuk Fai Ryan Ho 

Study leader:

Prof. Eric Lee Kam Pui 

申请注册联系人电话:

Applicant telephone:

+852 2252 8742 

研究负责人电话:

Study leader's telephone:

+852 2252 8742 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

yukfairyanho@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

lkp032@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

Room 426, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong SAR, China 

研究负责人通讯地址:

Room 402, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong SAR, China 

Applicant address:

Room 426, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong SAR, China 

Study leader's address:

Room 402, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

香港中文大學 

Applicant's institution:

The Chinese University of Hong Kong 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2020.486-T 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會 

Name of the ethic committee:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Comittee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-09-23 

伦理委员会联系人:

Envy Lee 

Contact Name of the ethic committee:

Envy LEE 

伦理委员会联系地址:

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓八樓 

Contact Address of the ethic committee:

8/F, Lui Che Woo Clinical Science Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

香港賽馬會慈善信託基金 

Primary sponsor:

The Hong Kong Jockey Club Charities Trust  

研究实施负责(组长)单位地址:

1 Sports Road, Happy Valley, Hong Kong, China 

Primary sponsor's address:

1 Sports Road, Happy Valley, Hong Kong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

香港賽馬會慈善信託基金 

Source(s) of funding:

The Hong Kong Jockey Club 

研究疾病:

2-10 children with autism spectrum disorder or attention deficit/hyperactivity disorder 

Target disease:

2-10 children with autism spectrum disorder or attention deficit/hyperactivity disorder 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

To design a multicomponent online health intervention for children with special educational need (SEN) and their families during the COVID-19 pandemic. To evaluate the effectiveness of the online intervention in improving overall well-being in both children and parents and reducing parenting stress and increasing childrens healthy lifestyle behaviours. 

Objectives of Study:

To design a multicomponent online health intervention for children with special educational need (SEN) and their families during the COVID-19 pandemic. To evaluate the effectiveness of the online intervention in improving overall well-being in both children and parents and reducing parenting stress and increasing childrens healthy lifestyle behaviours. To provide children with SEN and their parents with the multicomponent online health intervention during and after the COVID-19 pandemic.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

(1) children aged 2-10 years who have been previously diagnosed with ASD or ADHD or both by a doctor/psychologist according to the Diagnostic and Statistical Manual of Mental Disorders-4/5 (DSM-4/5) diagnostic criteria; (2) and at least one of their parents agrees to participate.  

Inclusion criteria

(1) children aged 2-10 years who have been previously diagnosed with ASD or ADHD or both by a doctor/psychologist according to the Diagnostic and Statistical Manual of Mental Disorders-4/5 (DSM-4/5) diagnostic criteria; (2) and at least one of their parents agrees to participate.  

排除标准:

(1) being unable to communicate and understand Chinese language as the intervention will be conducted in Chinese, (2) having a medical condition rendering him/her to be incapable to participate in the study; (3) unwilling or unable to give consent. 

Exclusion criteria:

(1) being unable to communicate and understand Chinese language as the intervention will be conducted in Chinese, (2) having a medical condition rendering him/her to be incapable to participate in the study; (3) unwilling or unable to give consent. 

研究实施时间:

Study execute time:

From2020-11-02To 2021-12-02 

征募观察对象时间:

Recruiting time:

From2020-11-02To 2021-10-02 

干预措施:

Interventions:

组别:

Child with SEN and their parents

样本量:

1500

Group:

Child with SEN and their parents

Sample size:

干预措施:

multi-component online health intervention

干预措施代码:

Intervention:

multi-component online health intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

 

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

CBCL - externalizing problem

指标类型:

主要指标 

Outcome:

CBCL - externalizing problem

Type:

Primary indicator 

测量时间点:

baseline and after intervention

测量方法:

questionnaire

Measure time point of outcome:

baseline and after intervention

Measure method:

questionnaire

指标中文名:

CBCL - anxious/depressed problem

指标类型:

次要指标 

Outcome:

CBCL - anxious/depressed problem

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SWAN

指标类型:

次要指标 

Outcome:

SWAN

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CARS

指标类型:

次要指标 

Outcome:

CARS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

PSI

指标类型:

次要指标 

Outcome:

PSI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

APQ

指标类型:

次要指标 

Outcome:

APQ

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

N/A

组织:

Sample Name:

NA

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 2 years
最大 Max age 10 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A

Randomization Procedure (please state who generates the random number sequence and by what method):

NA

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

For who interested in IPD will contact PI and we will provide it upon a reasonable request

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

For who interested in IPD will contact PI and we will provide it upon a reasonable request

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

Data will be collected online and secured in a password-protected folder

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data will be collected online and secured in a password-protected folder

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-10-05
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