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提升專注力不足/過度活躍兒童及其家庭的身心健康
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注册号:

Registration number:

ChiCTR-IOR-15007292 

最近更新日期:

Date of Last Refreshed on:

2015-10-28 

注册时间:

Date of Registration:

2015-10-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

提升專注力不足/過度活躍兒童及其家庭的身心健康 

Public title:

Promoting wellbeing of families with children at-risk of Attention Deficit Hyperactivity Disorder (ADHD) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

提升專注力不足/過度活躍兒童及其家庭的身心健康 

Scientific title:

Promoting wellbeing of families with children at-risk of Attention Deficit Hyperactivity Disorder (ADHD) 

研究课题代号(代码):

Study subject ID:

3-3-201504_03 

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:

CUHK_CCRB00481 

申请注册联系人:

Hay Ming Herman Lo 

研究负责人:

Hay Ming Herman Lo 

Applicant:

Hay Ming Herman Lo 

Study leader:

Hay Ming Herman Lo 

申请注册联系人电话:

Applicant telephone:

+852 34428116 

研究负责人电话:

Study leader's telephone:

+852 34428116 

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:

hm.lo@cityu.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

hm.lo@cityu.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/328 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/328 

申请注册联系人通讯地址:

B7409, AC1, City University of Hong Kong, Tat Chee Avenue, Kowloon Tong 

研究负责人通讯地址:

B7409, AC1, City University of Hong Kong, Tat Chee Avenue, Kowloon Tong 

Applicant address:

B7409, AC1, City University of Hong Kong, Tat Chee Avenue, Kowloon Tong 

Study leader's address:

B7409, AC1, City University of Hong Kong, Tat Chee Avenue, Kowloon Tong 

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:

Department of Applied Social Sciences, City University of Hong Kong 

Applicant's institution:

Department of Applied Social Sciences, City 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:

3-3-201504_03 

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:

Research Grants & Contracts Office, City University of Hong Kong 

Name of the ethic committee:

Research Grants & Contracts Office, City University of Hong Kong 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-06-01 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

City University of Hong Kong 

Primary sponsor:

City University of Hong Kong 

研究实施负责(组长)单位地址:

City University of Hong Kong 

Primary sponsor's address:

City University of Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

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):

Hong Kong Family Welfare Society, Christian Family Service Centre, Yang Memorial Methodist Social Service

具体地址:

Hong Kong Family Welfare Society, Christian Family Service Centre, Yang Memorial Methodist Social Service

Institution
hospital:

Hong Kong Family Welfare Society, Christian Family Service Centre, Yang Memorial Methodist Social Service

Address:

Hong Kong Family Welfare Society, Christian Family Service Centre, Yang Memorial Methodist Social Service

经费或物资来源:

Health Care and Promotion Fund, the Government of the Hong Kong Special Administrative Region 

Source(s) of funding:

Health Care and Promotion Fund, the Government of the Hong Kong Special Administrative Region 

研究疾病:

Attention Deficit Hyperactivity Disorder 

Target disease:

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:

提升專注力不足/過度活躍兒童及其家庭的身心健康 

Objectives of Study:

Promoting wellbeing of families with children at-risk of Attention Deficit Hyperactivity Disorder (ADHD) 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

Children's age is 5 to 7; Children reach the borderline cutoff scores of Strengths and Weaknesses of ADHD Symptoms and Normal Behaviours Rating Scale (SWAN); Both parents and children are committed to join the program. 

Inclusion criteria

Children's age is 5 to 7; Children reach the borderline cutoff scores of Strengths and Weaknesses of ADHD Symptoms and Normal Behaviours Rating Scale (SWAN); Both parents and children are committed to join the program. 

排除标准:

Children have autism, developmental delay or other developmental disorders which may influence the learning or the course of the lessons.  

Exclusion criteria:

Children have autism, developmental delay or other developmental disorders which may influence the learning or the course of the lessons. 

研究实施时间:

Study execute time:

FromTo  

征募观察对象时间:

Recruiting time:

From2015-11-01To  

干预措施:

Interventions:

组别:

Two groups

样本量:

200

Group:

Two groups

Sample size:

干预措施:

Mindfulness-based intervention. This is a family-based intervention, including a parent programme and a children programme. The design of the parent programme is based on mindfulness-based intervention. The content is adjusted with the special needs of parents having children with ADHD, or at risk of ADHD.

干预措施代码:

Intervention:

Mindfulness-based intervention. This is a family-based intervention, including a parent programme and a children programme. The design of the parent programme is based on mindfulness-based intervention. The content is adjusted with the special needs of parents having children with ADHD, or at risk of ADHD.

Intervention code:

组别:

(to be continued)

样本量:

0

Group:

(to be continued)

Sample size:

干预措施:

The parent programme has six 1.5-hour weekly sessions in group setting, and the children programme has eight 1 hour weekly sessions in group setting. Both contains the exercises of mindful breathing, mindful sitting, bodyscan, stretching, reflection, discussion and sharing.

干预措施代码:

Intervention:

The parent programme has six 1.5-hour weekly sessions in group setting, and the children programme has eight 1 hour weekly sessions in group setting. Both contains the exercises of mindful breathing, mindful sitting, bodyscan, stretching, reflection, discussion and sharing.

Intervention code:

组别:

(to be continued)

样本量:

0

Group:

(to be continued)

Sample size:

干预措施:

6 weeks for parents and 8 weeks for children, 1.5 hour per week for parents and 1 hour per week for children, once a week. Control group: Treatment as usual

干预措施代码:

Intervention:

6 weeks for parents and 8 weeks for children, 1.5 hour per week for parents and 1 hour per week for children, once a week. Control group: Treatment as usual

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):

City University of Hong Kong 

单位级别:

City University of Hong Kong 

Institution
hospital:

City University of Hong Kong  

Level of the institution:

City University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

Parental stress. Questionnaire: Parenting Stress Index Short Form.

指标类型:

主要指标 

Outcome:

Parental stress. Questionnaire: Parenting Stress Index Short Form.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Child ADHD problems. Questionnaire: Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Rating Scales.

指标类型:

主要指标 

Outcome:

Child ADHD problems. Questionnaire: Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Rating Scales.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Child attention. Computer-based test: Child Attention Network Test.

指标类型:

主要指标 

Outcome:

Child attention. Computer-based test: Child Attention Network Test.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Parents' mindfulness in parenting. Questionnaire: Interpersonal Mindfulness in Parenting.

指标类型:

次要指标 

Outcome:

Parents' mindfulness in parenting. Questionnaire: Interpersonal Mindfulness in Parenting.

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Parental ADHD problems. Questionnaire: World Health Organization Adult ADHD Self-Report Scale.

指标类型:

次要指标 

Outcome:

Parental ADHD problems. Questionnaire: World Health Organization Adult ADHD Self-Report Scale.

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Heart rate variability of parents and children. Apparatus-based measurement: A heart belt with an electronic watch.

指标类型:

次要指标 

Outcome:

Heart rate variability of parents and children. Apparatus-based measurement: A heart belt with an electronic watch.

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Child behavioral problems. Questionnaire: Child Behavior Checklist.

指标类型:

次要指标 

Outcome:

Child behavioral problems. Questionnaire: Child Behavior Checklist.

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:

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 5 years
最大 Max age 7 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):

Randomisation

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

Randomisation

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

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

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-10-28
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