ChiCTR2000029016 版本V1.0 版本创建时间2020/11/19 21:18:24 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：

 ChiCTR2000029016 

最近更新日期：

Date of Last Refreshed on：

 2020-01-11 18:07:53 

注册时间：

Date of Registration：

 2020-01-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Enhancing Family Wellness through Parallel Parent–Child Mindfulness Intervention in Migrant Communities

Public title：

Enhancing Family Wellness through Parallel Parent–Child Mindfulness Intervention in Migrant Communities

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Enhancing Family Wellness through Parallel Parent–Child Mindfulness Intervention in Migrant Communities

Scientific title：

Enhancing Family Wellness through Parallel Parent–Child Mindfulness Intervention in Migrant Communities

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：

Lyu Renhui 

研究负责人：

Lu Shuang 

Applicant：

Lyu Renhui 

Study leader：

Lu Shuang 

申请注册联系人电话：

Applicant telephone：

 +852 69907971

研究负责人电话：

Study leader's
telephone：

+852 3917 2080

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：

 u3006280@connect.hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 shuanglu@hku.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 712, Jockey Club Tower, Centennial Campus, HKU, HKSRA, China

研究负责人通讯地址：

Room 523, Jockey Club Tower, Centennial Campus, HKU, HKSRA, China

Applicant address：

Room 712, Jockey Club Tower, Centennial Campus, HKU, HKSRA, China

Study leader's address：

Room 523, Jockey Club Tower, Centennial Campus, HKU, HKSRA, China

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：

香港中文大學社會工作和社會管理系

Applicant's institution：

Department of Social Work and Social Administration, University of Hong Kong

研究负责人所在单位：

香港中文大學社會工作和社會管理系

Affiliation of the Leader：

Department of Social Work and Social Administration, 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：

 EA1910015

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：

香港中文大學人體研究倫理聯席委員會

Name of the ethic committee：

Human Research Ethics Committee, University of Hong Kong

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-11-22 00:00:00

伦理委员会联系人：

香港中文大學人體研究倫理聯席委員會

Contact Name of the ethic committee：

Human Research Ethics Committee

伦理委员会联系地址：

Research Services, The Registry The University of Hong Kong 9th Floor, Knowles Building Pokfulam, Hong Kong

Contact Address of the ethic committee：

Research Services, The Registry The University of Hong Kong 9th Floor, Knowles Building Pokfulam, Hong Kong

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：

香港中文大學

Primary sponsor：

The University of Hong Kong

研究实施负责（组长）单位地址：

The University of Hong Kong, Pokfulam Road, Hong Kong

Primary sponsor's address：

The University of Hong Kong, Pokfulam Road, 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：

Knowledge Exchange (KE) Funding

Source(s) of funding：

Knowledge Exchange (KE) Funding

研究疾病：

parental stress, family function  

Target disease：

parental stress, family function

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

(1) To examine the effectiveness of a parallel mindfulness parent-child intervention on parenting stress, parental interpersonal mindfulness, child mindfulness, and family functioning among low-income rural-to-urban migrant families; (2) To empower community organizations to use evidence-based interventions to work with the under-served migrant families.  

Objectives of Study：

(1) To examine the effectiveness of a parallel mindfulness parent-child intervention on parenting stress, parental interpersonal mindfulness, child mindfulness, and family functioning among low-income rural-to-urban migrant families; (2) To empower community organizations to use evidence-based interventions to work with the under-served migrant families.

药物成份或治疗方案详述：

The intervention is adapted from the Mindfulness-based Stress Reduction and Mindfulness Parenting curriculum, including topics on emotional awareness and regulation, using sensational awareness to cope with stress, mindful communication, and applying mindfulness in parent-child interaction. Didactic lectures, group discussions, and experiential activities will be used in each session. Meanwhile, the child group will be in a separate room for the same amount of time as the parent group. The intervention covers the same topics as parent intervention, but the content and activities are adapted to fit children's developmental stage. 

Description for medicine or protocol of treatment in detail：

The intervention is adapted from the Mindfulness-based Stress Reduction and Mindfulness Parenting curriculum, including topics on emotional awareness and regulation, using sensational awareness to cope with stress, mindful communication, and applying mindfulness in parent-child interaction. Didactic lectures, group discussions, and experiential activities will be used in each session. Meanwhile, the child group will be in a separate room for the same amount of time as the parent group. The intervention covers the same topics as parent intervention, but the content and activities are adapted to fit children's developmental stage. 

纳入标准：

Migrant parents (either father or mother) without official Shenzhen residency, and their children aged 9-12 years

Inclusion criteria

Migrant parents (either father or mother) without official Shenzhen residency, and their children aged 9-12 years

排除标准：

exclude children and parents who have a clinical diagnosis of severe mental illness, or children with special education needs (e.g. ADHD, Autism Spectrum Disorder, learning disabilities)

Exclusion criteria：

exclude children and parents who have a clinical diagnosis of severe mental illness, or children with special education needs (e.g. ADHD, Autism Spectrum Disorder, learning disabilities)

研究实施时间：

Study execute time：

从 From 2019-09-01 00:00:00至 To 2020-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-01-13 00:00:00 至 To 2020-02-01 00:00:00

干预措施：

Interventions：

组别：

Parent intervention group

样本量：

 30

Group：

Parent intervention group

Sample size：

干预措施：

8-week Mindfulness parenting curriculum

干预措施代码：

Intervention：

8-week Mindfulness parenting curriculum

Intervention code：

组别：

Children intervention group

样本量：

 30

Group：

Children intervention group

Sample size：

干预措施：

8-week Mindfulness children curriculum

干预措施代码：

Intervention：

8-week Mindfulness children curriculum

Intervention code：

组别：

Parent wait-list control group

样本量：

 30

Group：

Parent wait-list control group

Sample size：

干预措施：

blank control

干预措施代码：

Intervention：

blank control

Intervention code：

组别：

children wait-list control group

样本量：

 30

Group：

children wait-list control group

Sample size：

干预措施：

blank control

干预措施代码：

Intervention：

blank control

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 廣東 

市(区县)：

 深圳 

Country：

China

Province：

Guangdong

City：

Shenzhen

单位(医院)：

 深圳帝利社會工作服務中心（NGO） 

单位级别：

  

Institution
hospital：

Shenzhen Dili Social Work Service Center (NGO)

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Child and Adolescent Mindfulness

指标类型：

主要指标

Outcome：

Child and Adolescent Mindfulness

Type：

Primary indicator

测量时间点：

pre-test and post-test

测量方法：

self report

Measure time point of outcome：

pre-test and post-test

Measure method：

self report

指标中文名：

parenting stress

指标类型：

主要指标

Outcome：

parenting stress

Type：

Primary indicator

测量时间点：

pre-test and post-test

测量方法：

self report

Measure time point of outcome：

pre-test and post-test

Measure method：

self report

指标中文名：

parenting mindfulness

指标类型：

主要指标

Outcome：

parenting mindfulness

Type：

Primary indicator

测量时间点：

pre-test and post-test

测量方法：

self report

Measure time point of outcome：

pre-test and post-test

Measure method：

self report

指标中文名：

parent-child attachment

指标类型：

主要指标

Outcome：

parent-child attachment

Type：

Primary indicator

测量时间点：

pre-test and post-test

测量方法：

self report

Measure time point of outcome：

pre-test and post-test

Measure method：

self report

指标中文名：

Strengths and Difficulties of children

指标类型：

主要指标

Outcome：

Strengths and Difficulties of children

Type：

Primary indicator

测量时间点：

pre-test and post-test

测量方法：

self report

Measure time point of outcome：

pre-test and post-test

Measure method：

self report

指标中文名：

Mindful awareness attention

指标类型：

主要指标

Outcome：

Mindful awareness attention

Type：

Primary indicator

测量时间点：

pre-test and post-test

测量方法：

self report

Measure time point of outcome：

pre-test and post-test

Measure method：

self report

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 岁 years
最大 Max age 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）：

A research assistant will use a computerized randomization program to allocate participants to intervention and wait-list control groups on a 1:1 ratio.

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

A research assistant will use a computerized randomization program to allocate participants to intervention and wait-list control groups on a 1:1 ratio.

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：

Open label

Blinding：

Open label

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

是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）：

https://hub.hku.hk/advanced-search?location=crisdataset

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

https://hub.hku.hk/advanced-search?location=crisdataset

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 in hardcopy. Indirect personal identifiers will be used to link participants to their responses. Direct identifiers will be removed after entering all assessments into Excel. Data will be kept for no more than 5 years after the study completes.

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

Data will be collected in hardcopy. Indirect personal identifiers will be used to link participants to their responses. Direct identifiers will be removed after entering all assessments into Excel. Data will be kept for no more than 5 years after the study completes.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-01-11 18:07:53