中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

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：

从From至To

征募观察对象时间：

Recruiting time：

从From2015-11-01至To

干预措施：

Interventions：

组别：	Two groups	样本量：	200
Group：	Two groups	Sample size：	200
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：	0
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：	0
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	岁 years
最大 Max age	7	岁 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）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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