ChiCTR2100044304 版本V1.1 版本创建时间2021/09/06 09:09:34 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：

 ChiCTR2100044304 

最近更新日期：

Date of Last Refreshed on：

 2021-09-06 09:09:04 

注册时间：

Date of Registration：

 2021-03-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Mindfulness-based Therapeutic Parenting Group (MTPG) for Parents with Adverse Childhood Experiences (ACEs): A Randomized Controlled Trial

Public title：

Mindfulness-based Therapeutic Parenting Group (MTPG) for Parents with Adverse Childhood Experiences (ACEs): A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Mindfulness-based Therapeutic Parenting Group (MTPG) for Parents with Adverse Childhood Experiences (ACEs): A Randomized Controlled Trial

Scientific title：

Mindfulness-based Therapeutic Parenting Group (MTPG) for Parents with Adverse Childhood Experiences (ACEs): A Randomized Controlled Trial

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：

吕仁慧 

研究负责人：

吕仁慧 

Applicant：

Lyu Renhui 

Study leader：

Lyu Renhui 

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 69907971

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：

 u3006280@connect.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, Hong Kong University, Hong Kong Special Administrative Region, China

研究负责人通讯地址：

Room 712, Jockey Club Tower, Centennial Campus, Hong Kong University, Hong Kong Special Administrative Region, China

Applicant address：

Room 712, Jockey Club Tower, Centennial Campus, Hong Kong University, Hong Kong Special Administrative Region, China

Study leader's address：

Room 712, Jockey Club Tower, Centennial Campus, Hong Kong University, Hong Kong Special Administrative Region, 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：

香港大學

Applicant's institution：

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

研究负责人所在单位：

香港大學

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：

 EA210069

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：

香港大學人類研究倫理委員會

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：

 2021-03-12 00:00:00

伦理委员会联系人：

香港大學人類研究倫理委員會

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：

N/A

Primary sponsor：

N/A

研究实施负责（组长）单位地址：

N/A

Primary sponsor's address：

N/A

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

N/A

Source(s) of funding：

N/A

研究疾病：

N/A  

Target disease：

N/A

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：

This project aims to improve the parenting and reduce parental stress of parents with adverse childhood experiences (ACEs). An 8-week Mindfulness-based Therapeutic Parenting Group (MTPG) intervention protocol that integrates basic mindfulness elements with group therapy will be developed. A randomized controlled trial will be conducted to examine the effectiveness of MTPG compared with an active control condition. Outcomes will be assessed at baseline before intervention, post-intervention, and 1 month after the intervention.  

Objectives of Study：

This project aims to improve the parenting and reduce parental stress of parents with adverse childhood experiences (ACEs). An 8-week Mindfulness-based Therapeutic Parenting Group (MTPG) intervention protocol that integrates basic mindfulness elements with group therapy will be developed. A randomized controlled trial will be conducted to examine the effectiveness of MTPG compared with an active control condition. Outcomes will be assessed at baseline before intervention, post-intervention, and 1 month after the intervention.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria are parents who:
(1) at least have one school-age child below age 18 years old;
(2) are living with the child;
(3) express difficulties in handling the relationship with the child, including having a hard time in child-rearing, viewing child-rearing to be difficult, experiencing frequent conflicts with child, perceiving that her or his own parenting is problematic or wanting to improve the current parenting;
(4) have at least one type of adverse childhood experience listed in Adverse Childhood Experience (ACE) Questionnaire.

Inclusion criteria

Inclusion criteria are parents who:
(1) at least have one school-age child below age 18 years old;
(2) are living with the child;
(3) express difficulties in handling the relationship with the child, including having a hard time in child-rearing, viewing child-rearing to be difficult, experiencing frequent conflicts with child, perceiving that her or his own parenting is problematic or wanting to improve the current parenting;
(4) have at least one type of adverse childhood experience listed in Adverse Childhood Experience (ACE) Questionnaire.

排除标准：

Parents with severe mental illness (e.g. major depression, schizophrenia) or risk of committing suicide.

Exclusion criteria：

Parents with severe mental illness (e.g. major depression, schizophrenia) or risk of committing suicide.

研究实施时间：

Study execute time：

从 From 2021-03-20 00:00:00至 To 2022-03-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-03-25 00:00:00 至 To 2021-04-30 00:00:00

干预措施：

Interventions：

组别：

Parent intervention group

样本量：

 46

Group：

Parent intervention group

Sample size：

干预措施：

8-week Mindfulness group curriculum

干预措施代码：

Intervention：

8-week Mindfulness group curriculum

Intervention code：

组别：

Parent active control group

样本量：

 46

Group：

Parent active control group

Sample size：

干预措施：

Self-study reading materials parallel to the intervention group.

干预措施代码：

Intervention：

Self-study reading materials parallel to the intervention group.

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：

Parent Depression, Anxiety and Stress

指标类型：

主要指标

Outcome：

Parent Depression, Anxiety and Stress

Type：

Primary indicator

测量时间点：

Pre-, post- assessment (8 weeks, 2 months after intervention), and follow-up assessment after a month.

测量方法：

Measure time point of outcome：

Pre-, post- assessment (8 weeks, 2 months after intervention), and follow-up assessment after a month.

Measure method：

指标中文名：

Early maladaptive schemas

指标类型：

主要指标

Outcome：

Early maladaptive schemas

Type：

Primary indicator

测量时间点：

Pre-, post- assessment (8 weeks, 2 months after intervention), and follow-up assessment after a month.

测量方法：

Measure time point of outcome：

Pre-, post- assessment (8 weeks, 2 months after intervention), and follow-up assessment after a month.

Measure method：

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-, post- assessment (8 weeks, 2 months after intervention), and follow-up assessment after a month.

测量方法：

Measure time point of outcome：

Pre-, post- assessment (8 weeks, 2 months after intervention), and follow-up assessment after a month.

Measure method：

指标中文名：

Interpersonal Mindfulness in Parenting

指标类型：

主要指标

Outcome：

Interpersonal Mindfulness in Parenting

Type：

Primary indicator

测量时间点：

Pre-, post- assessment (8 weeks, 2 months after intervention), and follow-up assessment after a month.

测量方法：

Measure time point of outcome：

Pre-, post- assessment (8 weeks, 2 months after intervention), and follow-up assessment after a month.

Measure method：

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-, post- assessment (8 weeks, 2 months after intervention), and follow-up assessment after a month.

测量方法：

Measure time point of outcome：

Pre-, post- assessment (8 weeks, 2 months after intervention), and follow-up assessment after a month.

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 50 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：

Not stated

Blinding：

Not stated

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 online. Indirect personal identifiers will be used to link participants to their responses. data containing personal identifiers and anonymized data well be kept for 3 years after publication of the first paper arising from the research project.

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

Data will be collected in online. Indirect personal identifiers will be used to link participants to their responses. data containing personal identifiers and anonymized data well be kept for 3 years after publication of the first paper arising from the research project.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-03-16 05:20:01