Domestic Violence Enhanced Perinatal Care Program in China

June 6, 2026 updated by: Yang Li, University of Texas at Austin

Testing the Domestic Violence Enhanced Perinatal Care in China

The proposed project addresses intimate partner violence (IPV) against pregnant women, which is a serious social and health issue. Pregnant women represent a particularly vulnerable population of IPV survivors in China, who have been largely underserved. There have been no interventions developed in China to prevent maternal IPV and its effects on maternal and infant health. The proposed project is the first structured IPV intervention integrated into prenatal care in China, which may have the potential to be translated into more prenatal clinics in China to prevent violence against pregnant women and improve maternal and infant health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intimate partner violence (IPV) is a serious social and health issue. It is prevalent during pregnancy and in the postpartum period, causing tremendous effects on maternal and child health such as maternal depression, preterm birth, low birth weight, and impaired child neuropsychological development. However, IPV has been overlooked and is a low priority in China. No IPV intervention and prevention program has been implemented in China to help women deal with IPV in the perinatal period and eliminate its effects on maternal and child health. The Domestic Violence Enhanced Home Visitation Program (DOVE), which is a structured IPV intervention integrated into the perinatal home visitation program in the United States, focuses on educating and empowering women about IPV and their options for preventing further IPV. Building on the demonstrated effectiveness of the DOVE intervention in preventing IPV as well as the well-established perinatal care system in China, we adapted the DOVE intervention for the context of perinatal care in China. The aim of the proposed project is to test the feasibility and acceptability of the adapted DOVE intervention ("DOVE in China") in reducing maternal IPV and infant exposure to IPV and improving maternal and child health in a sample of women recruited from two perinatal clinics located in two cities (richer vs. poorer) of China. The pilot study will use a randomized two-arm pre-posttest control group design with repeated measures and mixed methods. A total of 25 women per group, who are in early pregnancy and screened positive for IPV in the year before pregnancy or during the current pregnancy, will be recruited at each of the two perinatal clinics. The intervention group will receive three prenatal sessions and one postpartum session, while the control group will receive standard of care. The frequency of IPV, depression, perceived stress, safety behaviors, birth outcomes, and child growth and development will be assessed on the web-based survey. The phone interview will ask about women's acceptability and satisfaction with the intervention and how it impacts their well-being. All women will complete the survey at baseline, 36-40 weeks before delivery, and 3 and 6 months postpartum. The interview will be conducted with women in the intervention group immediately post-intervention. The findings will help enhance the intervention by making appropriate modifications to the processes and procedures involved and provide a foundation upon which to implement a subsequent effectiveness trial. The findings will be disseminated through various means (e.g., publications, presentations). The long-term goal is to create an integrated, sustainable model for the universal screening, assessment, and treatment of IPV in China's perinatal care and improve the health of abused women and their infants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being in early pregnancy (less than 13 weeks gestation) and screened positive for IPV in the year before pregnancy or during the current pregnancy.

Exclusion Criteria:

  • Women who are not able to read and understand Chinese.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The DOVE in China Intervention Group
Our intervention consists of four major components: a) information about IPV and effects on maternal and infant health, b) danger assessment, c) options and safety plan, and d) resources.
Behavioral: Domestic Violence Enhanced Perinatal Care Program
Our intervention consists of four major components: a) information about IPV and its effects on maternal and infant health, b) danger assessment, c) options and safety plan, and d) resources.
Placebo Comparator: The Control Group
The control group will be provided with a standard of care including usual perinatal care (e.g., prenatal health education) and a list of resource information (e.g., crisis lines, local IPV, and mental health resources).
Behavioral: Standard of Care
Usual perinatal care (e.g., prenatal health education) and a list of resource information (e.g., crisis lines, local IPV and mental health resources)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intimate Partner Violence
Time Frame: Baseline
The Revised Conflict Tactics Scales (CTS2) will be used to measure the frequency of violent behaviors used by the partner. Higher total scores indicate more frequent violent behaviors from the partner.
Baseline
Intimate Partner Violence
Time Frame: 36-40 weeks before delivery
The Revised Conflict Tactics Scales (CTS2) will be used to measure the frequency of violent behaviors used by the partner. Higher total scores indicate more frequent violent behaviors from the partner.
36-40 weeks before delivery
Intimate Partner Violence
Time Frame: 3 months postpartum (6 weeks post-intervention)
The Revised Conflict Tactics Scales (CTS2) will be used to measure the frequency of violent behaviors used by the partner. Higher total scores indicate more frequent violent behaviors from the partner.
3 months postpartum (6 weeks post-intervention)
Intimate Partner Violence
Time Frame: 6 months postpartum (18 weeks post-intervention)
The Revised Conflict Tactics Scales (CTS2) will be used to measure the frequency of violent behaviors used by the partner. Higher total scores indicate more frequent violent behaviors from the partner.
6 months postpartum (18 weeks post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shandong University
Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SVRI2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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