ChiCTR1900022923 版本V1.2 版本创建时间2019/05/03 19:33:15 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR1900022923 

最近更新日期：

Date of Last Refreshed on：

2019-05-03 19:30:49 

注册时间：

Date of Registration：

2019-05-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Mindful Parents, Happy Kids

Public title：

Mindful Parents, Happy Kids

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Mindful Parents, Happy Kids

Scientific title：

Mindful Parents, Happy Kids

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：

Lawrence Luk 

研究负责人：

Prof. Samuel Wong Yeung Shan Samuel 

Applicant：

Lawrence Luk 

Study leader：

Prof. Samuel Wong Yeung Shan Samuel 

申请注册联系人电话：

Applicant telephone：

+852 2252-8463

研究负责人电话：

Study leader's telephone：

+852 22528774

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：

fujailuk@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

yeungshanwong@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：

中國香港特別行政區新界沙田威爾士親王醫院公共衛生學院4樓426室

研究负责人通讯地址：

中國香港特別行政區新界沙田威爾士親王醫院公共衛生學院4樓409室

Applicant address：

Rm426, 4/F School of Public Health, Prince of Wales Hospital, Shatin, Hong Kong, China

Study leader's address：

Rm409, 4/F School of Public Health, 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：

Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

Chinese University of Hong Kong

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

1

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

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 Committee

伦理委员会批准日期：

Date of approved by ethic committee：

1990-01-01 00:00:00

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威爾士親王醫院呂志和臨床科學大樓8樓

Contact Address of the ethic committee：

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

Fine Wine Experience

Primary sponsor：

Fine Wine Experience

研究实施负责（组长）单位地址：

中國香港特別行政區西營盤干諾道西（朝光街口）165-166號

Primary sponsor's address：

Shop A, 165-166 Connaught Road West (Entrance on Chiu Kwong Street), Sai Ying Pun, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Private

Source(s) of funding：

Private

Target disease：

Stress

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

Mindful Parents, Happy Kids aims at training up local Mindful Parenting facilitators to deliver mindful parenting course to local parents. The project also aims at establishing local tools, including sound tracks and information booklet for a wider and more sustainable development. Ultimately, we hope to increase parental well-being, improve parent-child relationship, and mental well-being of children.  

Objectives of Study：

Mindful Parents, Happy Kids aims at training up local Mindful Parenting facilitators to deliver mindful parenting course to local parents. The project also aims at establishing local tools, including sound tracks and information booklet for a wider and more sustainable development. Ultimately, we hope to increase parental well-being, improve parent-child relationship, and mental well-being of children.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Parents experiencing parenting stress with children age between 4 and 17 will be included. Those with a total score of 46 or above of PSS which suggests high level of parenting stress will be included

Inclusion criteria

Parents experiencing parenting stress with children age between 4 and 17 will be included. Those with a total score of 46 or above of PSS which suggests high level of parenting stress will be included

排除标准：

1) diagnosed psychiatric disorders such as psychotic, substance use disorders;
2) suicidality such as suicidal intention or plan;
3) physical conditions that leading to constraints in participation;
4) taking any mindfulness and parenting related course/training.

Exclusion criteria：

1) diagnosed psychiatric disorders such as psychotic, substance use disorders;
2) suicidality such as suicidal intention or plan;
3) physical conditions that leading to constraints in participation;
4) taking any mindfulness and parenting related course/training

研究实施时间：

Study execute time：

从 From 2019-05-03 00:00:00至 To 2031-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2019-05-08 00:00:00 至 To 2020-12-30 00:00:00  

干预措施：

Interventions：

组别：

Mindful parenting

样本量：

200

Group：

Mindful parenting

Sample size：

干预措施：

Mindful parenting

干预措施代码：

Intervention：

Mindful parenting

Intervention code：

组别：

Mindful parenting Intervention

样本量：

80

Group：

Mindful parenting Intervention

Sample size：

干预措施：

Mindful parenting

干预措施代码：

Intervention：

Mindful parenting

Intervention code：

组别：

Usual care waitlist control

样本量：

80

Group：

Usual care waitlist control

Sample size：

干预措施：

Usual care

干预措施代码：

Intervention：

Usual care

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：

HKSAR 

单位(医院)：

香港中文大學 

单位级别：

大學 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Parental Stress Scale

指标类型：

主要指标

Outcome：

Parental Stress Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Strengths and Difficulties Questionnaire

指标类型：

次要指标

Outcome：

Strengths and Difficulties Questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

WHO-5 Well-being Index

指标类型：

次要指标

Outcome：

WHO-5 Well-being Index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Multidimensional Assessment of Parenting Scale

指标类型：

次要指标

Outcome：

Multidimensional Assessment of Parenting 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：

Parenting Scale

指标类型：

次要指标

Outcome：

Parenting 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：

9-item Patient Health Questionnaire

指标类型：

次要指标

Outcome：

9-item Patient Health Questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

7-item Generalised Anxiety Disorder

指标类型：

次要指标

Outcome：

7-item Generalised Anxiety Disorder

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Interpersonal Mindfulness in Parenting Scale

指标类型：

次要指标

Outcome：

Interpersonal Mindfulness in Parenting 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：

Mindfulness practice

指标类型：

次要指标

Outcome：

Mindfulness practice

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 4 岁 years
最大 Max age 80 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

Simple randomization will be applied. The randomisation will be conducted by an experienced independent statistician using computer generated random results which will be stored in a pass-word protected computer kept by a research staff who is not involved in the study. Once an eligible parent is recruited in&#

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

Simple randomization will be applied. The randomisation will be conducted by an experienced independent statistician using computer generated random results which will be stored in a pass-word protected computer kept by a research staff who is not involved in the study. Once an eligible parent is recruited in&#

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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

Yes

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）：

Available upon request after trial completion

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

Available upon request after trial completion

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：

The study purpose and procedures will be explained in details to study participants. Consent form will be signed before data collection. Assessments will be conducted at baseline, after the intervention and 3 months after the intervention. In the end, a total of 400 parents including those in the trial (n=240) will be followed up every two years up to 10 years after intervention. Telephone reminders will be provided at least three times if the questionnaire is not returned or answered. A return envelope with stamp on it will be provided to them in each mail. Only for those who may have difficulties in mailing, we will consider to collect the information through other methods such as telephone survey. Original data will be locked in a password protected computer with access only to an authorized research personnel. She will be responsible for safekeeping of the personal data during and after the study.

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

The study purpose and procedures will be explained in details to study participants. Consent form will be signed before data collection. Assessments will be conducted at baseline, after the intervention and 3 months after the intervention. In the end, a total of 400 parents including those in the trial (n=240) will be followed up every two years up to 10 years after intervention. Telephone reminders will be provided at least three times if the questionnaire is not returned or answered. A return envelope with stamp on it will be provided to them in each mail. Only for those who may have difficulties in mailing, we will consider to collect the information through other methods such as telephone survey. Original data will be locked in a password protected computer with access only to an authorized research personnel. She will be responsible for safekeeping of the personal data during and after the study.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-05-03 19:28:57