- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05388565
Domestic Violence Enhanced Perinatal Care Program in China
May 8, 2023 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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
100
Phase
- 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
- Name: Fenglin Cao, MD
- Phone Number: 13065093172
- Email: caofenglin2008@126.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Shandong University
-
Contact:
- Fenglin Cao, PhD
- Phone Number: 13065093172
- Email: caofenglin2008@126.com
-
-
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
Ages Eligible for Study
16 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 |
Intervention / Treatment |
---|---|
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.
|
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).
|
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
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
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)
February 25, 2023
Primary Completion (Anticipated)
January 1, 2024
Study Completion (Anticipated)
February 1, 2024
Study Registration Dates
First Submitted
May 17, 2022
First Submitted That Met QC Criteria
May 19, 2022
First Posted (Actual)
May 24, 2022
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID 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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