【ChiCTR2600116651】Supporting the Transition to Parenthood: A Randomized Controlled Trial of a Couple-centered Psychosocial Intervention for Expectant Parents

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基本信息

登记号

ChiCTR2600116651

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2026-01-13

临床申请受理号

靶点

适应症

Pregnancy, childbirth, and puerperium

试验通俗题目

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

试验专业题目

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

申办单位信息

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

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.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

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.

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.

试验项目经费来源

The Hong Kong Polytechnic University

试验范围

目标入组人数

实际入组人数

第一例入组时间

2026-01-17

试验终止时间

2028-07-01

是否属于一致性

入选标准

1. Pregnant women between 3 and 7 months of gestation; 2. First pregnancy for the mother; 3. The pregnant woman’s partner is willing to participate in the study; and 4. Both the pregnant woman and their participating partner are able to understand and communicate in Cantonese Chinese.；

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.；

研究者信息

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试验机构

The Hong Kong Polytechnic University

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

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