Intimate Partner ViolenceNCT05388565
Domestic Violence Enhanced Perinatal Care Program in China
A study testing Domestic Violence Enhanced Perinatal Care Program in people with Intimate Partner Violence, run by University of Texas at Austin at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Domestic Violence Enhanced Perinatal Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2023to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being in early pregnancy (less than 13 weeks gestation) and screened positive for IPV in the year before pregnancy or during the current pregnancy.
Who cannot join
- Women who are not able to read and understand Chinese.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong University
Jinan, Shandong, 250012
Fenglin Cao, PhD, 13065093172, caofenglin2008@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Intimate Partner Violence
- Being tested
- Domestic Violence Enhanced Perinatal Care Program, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Domestic Violence Enhanced Perinatal Care ProgramBehavioural
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.
Standard of CareBehavioural
Usual perinatal care (e.g., prenatal health education) and a list of resource information (e.g., crisis lines, local IPV and mental health resources)
| Study group | Role | What they receive |
|---|---|---|
| The DOVE in China Intervention Group | Experimental | 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. Receives: Behavioral: Domestic Violence Enhanced Perinatal Care Program |
| The Control Group | Placebo comparator | 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). Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intimate Partner Violence
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.
Measured: Baseline
Intimate Partner Violence
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.
Measured: 36-40 weeks before delivery
Intimate Partner Violence
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.
Measured: 3 months postpartum (6 weeks post-intervention)
Intimate Partner Violence
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.
Measured: 6 months postpartum (18 weeks post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start25 Feb 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University, Soochow University
- Responsible party
- Principal investigator, Yang Li, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388565
- Sponsor's protocol ID
- SVRI2022
- Status last verified
- Jun 2026
- First submitted
- 17 May 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Domestic Violence Enhanced Perinatal Care in China
- ClinicalTrials.gov ID
- NCT05388565
- Acronym / sponsor ID
- SVRI2022
- Conditions
- Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Shandong University, Soochow University
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The DOVE in China Intervention Group | Experimental | Behavioral: Domestic Violence Enhanced Perinatal Care ProgramOur 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. |
| The Control Group | Placebo comparator | Behavioral: Standard of CareThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being in early pregnancy (less than 13 weeks gestation) and screened positive for IPV in the year before pregnancy or during the current pregnancy.
Key exclusion criteria (1 listed)
- Women who are not able to read and understand Chinese.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Domestic Violence Enhanced Perinatal Care ProgramOur 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. | Behavioural | The DOVE in China Intervention Group |
| Standard of CareUsual perinatal care (e.g., prenatal health education) and a list of resource information (e.g., crisis lines, local IPV and mental health resources) | Behavioural | The Control Group |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domestic Violence Enhanced Perinatal Care Program in people with Intimate Partner Violence, run by University of Texas at Austin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fenglin Cao, MD (13065093172, caofenglin2008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intimate Partner Violence (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.