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Supporting the Transition to Parenthood: A Randomized Controlled Trial of a Couple-centered Psychosocial Intervention for Expectant Parents
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注册号：

Registration number：

 ChiCTR2600116651 

最近更新日期：

Date of Last Refreshed on：

 2026-01-13 14:21:11 

注册时间：

Date of Registration：

 2026-01-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Supporting the Transition to Parenthood: A Randomized Controlled Trial of a Couple-centered Psychosocial Intervention for Expectant Parents

Public title：

Supporting the Transition to Parenthood: A Randomized Controlled Trial of a Couple-centered Psychosocial Intervention for Expectant Parents

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Supporting the Transition to Parenthood: A Randomized Controlled Trial of a Couple-centered Psychosocial Intervention for Expectant Parents

Scientific title：

Supporting the Transition to Parenthood: A Randomized Controlled Trial of a Couple-centered Psychosocial Intervention for Expectant Parents

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：

盧健銘 

研究负责人：

盧健銘 

Applicant：

Dr. Camilla Lo 

Study leader：

Dr. Camilla Lo 

申请注册联系人电话：

Applicant telephone：

 +852 2766 5760

研究负责人电话：

Study leader's
telephone：

+852 2766 5760

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：

 camilla.lo@polyu.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 camilla.lo@polyu.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：

Room 429, 4/F, Block HJ, Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong

研究负责人通讯地址：

Room 429, 4/F, Block HJ, Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong

Applicant address：

Room 429, 4/F, Block HJ, Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong

Study leader's address：

Room 429, 4/F, Block HJ, Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hung Hom, 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：

The Hong Kong Polytechnic University

Applicant's institution：

The Hong Kong Polytechnic University

研究负责人所在单位：

The Hong Kong Polytechnic University

Affiliation of the Leader：

The Hong Kong Polytechnic University

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：

 HSEARS20251013003

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：

The Hong Kong Polytechnic University Institutional Review Board

Name of the ethic committee：

The Hong Kong Polytechnic University Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-19 00:00:00

伦理委员会联系人：

Siu Yuen Man, Delegate

Contact Name of the ethic committee：

Siu Yuen Man, Delegate

伦理委员会联系地址：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

Contact Address of the ethic committee：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2766 6378

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 judy.ym.siu@polyu.edu.hk

研究实施负责（组长）单位：

The Hong Kong Polytechnic University

Primary sponsor：

The Hong Kong Polytechnic University

研究实施负责（组长）单位地址：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

Primary sponsor's address：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong SAR

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Department of Applied Social Sciences

具体地址：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

Institution
hospital：

The Hong Kong Polytechnic University

Address：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

经费或物资来源：

The Hong Kong Polytechnic University

Source(s) of funding：

The Hong Kong Polytechnic University

研究疾病：

Pregnancy, childbirth, and puerperium  

Target disease：

Pregnancy, childbirth, and puerperium

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The primary aim of this research project is to develop and evaluate the efficacy of a couple-centered psychosocial intervention in supporting expectant parents as they transition to parenthood. Specifically, the project seeks to provide early, targeted support during this transitional phase, with a strong emphasis on strengthening couple relationships. The ultimate goal is to ensure that parents are better prepared and supported both before and after the arrival of their child, thereby promoting healthier family dynamics and improved outcomes for parents and children. Specific objectives include: 1. Evaluate the intervention's impacts on couple relationship quality and satisfaction. 2. Evaluate the intervention's impact on parental mental health for both mothers and fathers. 3. Evaluate the intervention's impact on parenting behaviors and competence. 4. Evaluate the intervention’s impact on perceived social support. 5. Explore participants’ perceived usefulness of the intervention.  

Objectives of Study：

The primary aim of this research project is to develop and evaluate the efficacy of a couple-centered psychosocial intervention in supporting expectant parents as they transition to parenthood. Specifically, the project seeks to provide early, targeted support during this transitional phase, with a strong emphasis on strengthening couple relationships. The ultimate goal is to ensure that parents are better prepared and supported both before and after the arrival of their child, thereby promoting healthier family dynamics and improved outcomes for parents and children. Specific objectives include: 1. Evaluate the intervention's impacts on couple relationship quality and satisfaction. 2. Evaluate the intervention's impact on parental mental health for both mothers and fathers. 3. Evaluate the intervention's impact on parenting behaviors and competence. 4. Evaluate the intervention’s impact on perceived social support. 5. Explore participants’ perceived usefulness of 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

排除标准：

Physical or mental health conditions that would significantly interfere with participation, or pose a safety concern, as determined by the research team.

Exclusion criteria：

Physical or mental health conditions that would significantly interfere with participation, or pose a safety concern, as determined by the research team.

研究实施时间：

Study execute time：

从 From 2026-01-17 00:00:00至 To 2028-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-17 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 64

Group：

Intervention group

Sample size：

干预措施：

The intervention group will receive six program sessions (90 minutes per session) designed to support couples throughout their transition to parenthood, starting with mental and physical preparation during pregnancy. At the pre-natal stage, intervention sessions focus on helping couples understand each other's strengths and roles as future parents, fostering effective communication, and resolving conflicts that may arise regarding parenting approaches. This foundation is enhanced by prenatal yoga class, which incorporate modified poses and relaxation techniques to reduce stress and prepare for labor; fathers are encouraged to participate for increased support and bonding. Expert online talk from obstetrician and gynecologist / midwives provides valuable knowledge about maternal physiological changes, labor preparation, and the significance of prenatal nutrition, enabling couples to make informed prenatal care decisions. At the postnatal stage, support is equally emphasized, including online session on practical newborn care led by experienced postpartum nanny and discussions on addressing emotional challenges faced by new mothers. Baby massage workshop teaches parents how to strengthen emotional bonds and aid infants’ physical development. The program concludes with a celebratory reflection session, reviewing the couple’s journey, reinforcing their confidence and relationship, and preparing them for the next stage of parenthood. The overall aim is to equip couples with the skills, knowledge, and emotional resilience needed to thrive as new parents.

干预措施代码：

Intervention：

The intervention group will receive six program sessions (90 minutes per session) designed to support couples throughout their transition to parenthood, starting with mental and physical preparation during pregnancy. At the pre-natal stage, intervention sessions focus on helping couples understand each other's strengths and roles as future parents, fostering effective communication, and resolving conflicts that may arise regarding parenting approaches. This foundation is enhanced by prenatal yoga class, which incorporate modified poses and relaxation techniques to reduce stress and prepare for labor; fathers are encouraged to participate for increased support and bonding. Expert online talk from obstetrician and gynecologist / midwives provides valuable knowledge about maternal physiological changes, labor preparation, and the significance of prenatal nutrition, enabling couples to make informed prenatal care decisions. At the postnatal stage, support is equally emphasized, including online session on practical newborn care led by experienced postpartum nanny and discussions on addressing emotional challenges faced by new mothers. Baby massage workshop teaches parents how to strengthen emotional bonds and aid infants’ physical development. The program concludes with a celebratory reflection session, reviewing the couple’s journey, reinforcing their confidence and relationship, and preparing them for the next stage of parenthood. The overall aim is to equip couples with the skills, knowledge, and emotional resilience needed to thrive as new parents.

Intervention code：

组别：

Active control group

样本量：

 64

Group：

Active control group

Sample size：

干预措施：

This group will receive a brief version of the intervention with only two program sessions: one during the prenatal stage featuring an online talk by obstetrician and gynecologist / midwvies, and the other during the postnatal stage led by a postpartum nanny.

干预措施代码：

Intervention：

This group will receive a brief version of the intervention with only two program sessions: one during the prenatal stage featuring an online talk by obstetrician and gynecologist / midwvies, and the other during the postnatal stage led by a postpartum nanny.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong  

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 The Boys' and Girls' Clubs Association of Hong Kong 

单位级别：

 N/A 

Institution
hospital：

The Boys' and Girls' Clubs Association of Hong Kong

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

Marital adjustment

指标类型：

主要指标

Outcome：

Marital adjustment

Type：

Primary indicator

测量时间点：

测量方法：

The Chinese version of the Revised Dyadic Adjustment Scale

Measure time point of outcome：

Measure method：

The Chinese version of the Revised Dyadic Adjustment Scale

指标中文名：

Marital satisfaction

指标类型：

主要指标

Outcome：

Marital satisfaction

Type：

Primary indicator

测量时间点：

测量方法：

The Chinese version of the Kansas Marital Satisfaction Scale

Measure time point of outcome：

Measure method：

The Chinese version of the Kansas Marital Satisfaction Scale

指标中文名：

Marital communication

指标类型：

主要指标

Outcome：

Marital communication

Type：

Primary indicator

测量时间点：

测量方法：

Marital Communication Scale

Measure time point of outcome：

Measure method：

Marital Communication Scale

指标中文名：

Attachment anxiety and avoidance

指标类型：

主要指标

Outcome：

Attachment anxiety and avoidance

Type：

Primary indicator

测量时间点：

测量方法：

The Experience in Close Relationships-Revised

Measure time point of outcome：

Measure method：

The Experience in Close Relationships-Revised

指标中文名：

Depression

指标类型：

次要指标

Outcome：

Depression

Type：

Secondary indicator

测量时间点：

测量方法：

Chinese version of the Edinburgh Postnatal Depression Scale

Measure time point of outcome：

Measure method：

Chinese version of the Edinburgh Postnatal Depression Scale

指标中文名：

Stress and Anxiety

指标类型：

次要指标

Outcome：

Stress and Anxiety

Type：

Secondary indicator

测量时间点：

测量方法：

Stress and anxiety subscales of the Chinese version of the Depression Anxiety and Stress Scale

Measure time point of outcome：

Measure method：

Stress and anxiety subscales of the Chinese version of the Depression Anxiety and Stress Scale

指标中文名：

Life satisfaction

指标类型：

次要指标

Outcome：

Life satisfaction

Type：

Secondary indicator

测量时间点：

测量方法：

Chinese version of the Satisfaction with Life Scale

Measure time point of outcome：

Measure method：

Chinese version of the Satisfaction with Life Scale

指标中文名：

Perceived social support

指标类型：

次要指标

Outcome：

Perceived social support

Type：

Secondary indicator

测量时间点：

测量方法：

Multidimensional Scale of Perceived Social Support

Measure time point of outcome：

Measure method：

Multidimensional Scale of Perceived Social Support

指标中文名：

Parenting competence/self-efficacy

指标类型：

次要指标

Outcome：

Parenting competence/self-efficacy

Type：

Secondary indicator

测量时间点：

测量方法：

Parenting Sense of Competence Scale

Measure time point of outcome：

Measure method：

Parenting Sense of Competence Scale

指标中文名：

Parenting stress

指标类型：

次要指标

Outcome：

Parenting stress

Type：

Secondary indicator

测量时间点：

测量方法：

Parenting Stress Scale

Measure time point of outcome：

Measure method：

Parenting Stress Scale

指标中文名：

Adherence rate

指标类型：

附加指标

Outcome：

Adherence rate

Type：

Additional indicator

测量时间点：

测量方法：

An average of 80% adherence to the intervention, defined as the percentage of the total sessions attended

Measure time point of outcome：

Measure method：

An average of 80% adherence to the intervention, defined as the percentage of the total sessions attended

指标中文名：

Retention rate

指标类型：

附加指标

Outcome：

Retention rate

Type：

Additional indicator

测量时间点：

测量方法：

80% retention rate, defined as the number of participants completing the post-intervention assessments in the intervention group, divided by the total number of participants enrolled in the intervention group

Measure time point of outcome：

Measure method：

80% retention rate, defined as the number of participants completing the post-intervention assessments in the intervention group, divided by the total number of participants enrolled in the intervention group

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 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）：

Eligible and consenting participant couples will be randomly assigned to either the intervention group or a control group in a 1:1 allocation ratio. This ensures that any observed differences between groups can be attributed to the intervention, minimizing bias. A research assistant (RA1) not involved in the study will generate a random sequence for each site.

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

Eligible and consenting participant couples will be randomly assigned to either the intervention group or a control group in a 1:1 allocation ratio. This ensures that any observed differences between groups can be attributed to the intervention, minimizing bias. A research assistant (RA1) not involved in the study will generate a random sequence for each site.

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：

Participants will be blinded to their group allocation during the baseline assessment because randomization occurs only after baseline data collection. The full randomization sequence will be concealed from all study personnel except RA1. The data analyst (RA3) will be blinded to group allocation during analysis; group indicators in the data file will be masked using codes unknown to the analyst. No personnel involved in data analysis will participate in data collection or allocation procedures.

Blinding：

Participants will be blinded to their group allocation during the baseline assessment because randomization occurs only after baseline data collection. The full randomization sequence will be concealed from all study personnel except RA1. The data analyst (RA3) will be blinded to group allocation during analysis; group indicators in the data file will be masked using codes unknown to the analyst. No personnel involved in data analysis will participate in data collection or allocation procedures.

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）：

Data of the study will be made available at https://researchdata.lib.polyu.edu.hk/ after publication of the study’s findings.

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

Data of the study will be made available at https://researchdata.lib.polyu.edu.hk/ after publication of the study’s findings.

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 via Qualtrics, and data will be stored in the university's network drive, which is a stable and secure platform for data and file storage.

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

Data will be collected via Qualtrics, and data will be stored in the university's network drive, which is a stable and secure platform for data and file storage.

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：

  2026-01-13 14:20:53
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