Family DynamicsNCT06481631
Patient-clinical Linkages to Improve Trust and Engagement in Postpartum Healthcare
A study testing The PEN-3 Intervention Model in people with Family Dynamics and Trust in Healthcare System, run by Jackson State University at 1 site in United States.
Trial summary
Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Family Dynamics, Trust in Healthcare System, Family Structure
- What is being tested?
- The PEN-3 Intervention Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 30 Jun 2030
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Identified as high risk pregnancy
- Postpartum mothers/parents 18-45 years
- Resident of the one of 5 target counties (Washington, Bolivar, Scott, Humphreys, and Carroll)
- Maternal healthcare providers in target counties
- Maternal community health leaders
Who cannot join
- not identified as high risk pregnancy
- 18 years of age postpartum
- cesarean birth
- non-resident of the 5 target counties
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Jackson State University/Department of Behavioral & Environmental Health
Jackson, Mississippi, 39213
About this study
Official title: Empowering Women for Postpartum Care and Reproductive Health in Mississippi Delta
Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This patient-clinical linkages intervention study will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities.
These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity health and health care outcomes.
Read the detailed description
Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This research center will conduct two multi-layered research projects. Research Project 1 will determine the effectiveness of an evidenced-based community health worker home visiting program grounded in extensive patient and community participation. Research Project 2 will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities. These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity care.
- Conditions
- Family Dynamics, Trust in Healthcare System, Family Structure, Health Literacy, Contraception, Maternal Behavior
- Being tested
- The PEN-3 Intervention Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The PEN-3 Intervention ModelBehavioural
The PEN-3 Model is a sociocultural model for planning and assessing participant behavior within the context a cultural phenomenon. It will be used to assess intervention impact on patient-clinical linkages in the Mississippi Delta.
| Study group | Role | What they receive |
|---|---|---|
| PEN-3 Assessment Model | Other | Application of a sociocultural model to assess patient-clinical linkages that support positive maternal health outcomes Receives: Behavioral: The PEN-3 Intervention Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve trust in the healthcare system
Mixed methods approach using Trust in Physician Scale \& Researcher developed qualitative tool
Measured: 12 months from consent to participate
Increase maternal health literacy (patient and provider perspectives)
Brief literacy screening tool to evaluate health literacy in the health system (Qualitative and Quantitative Measures
Measured: 12 months from consent to participate in the intervention
Increase engagement in the maternal health care system (patient-clinic linkages)
Contraceptive Counseling measure tool to evaluate the patient experiences with provider care and vice-versa; minimally 2 post-partum clinec visits in postpartum period
Measured: 12 month from consent to participation in the intervention
Strengthen structuring of family support systems
Family crisis coping response (F-COPES) measure to determine patient (mother) and family perceptions and experiences with structuring family support fo postpartum care period.
Measured: 12 months from consent to participation in the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jun 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family DynamicsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trial with one arm.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jackson State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mississippi Medical Center, Harvard School of Public Health (HSPH), Mississippi State Department of Health
- Responsible party
- Sponsor
- Investigators
- Mary Shaw, PhD, Principal investigator, Jackson State UniversityMary Shaw, PHD, M.ED, Study director, Jackson State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481631
- Sponsor's protocol ID
- 1U54HD113238-02
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Women for Postpartum Care and Reproductive Health in Mississippi Delta
- ClinicalTrials.gov ID
- NCT06481631
- Acronym / sponsor ID
- 1U54HD113238-02
- Conditions
- Family Dynamics, Trust in Healthcare System, Family Structure, Health Literacy, Contraception, Maternal Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Jackson State UniversityUniversity, hospital or other
- Collaborators
- University of Mississippi Medical Center, Harvard School of Public Health (HSPH), Mississippi State Department of Health
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 1 Jul 2024 (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.
Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This patient-clinical linkages intervention study will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities.
These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity health and health care outcomes.
Detailed description
Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This research center will conduct two multi-layered research projects. Research Project 1 will determine the effectiveness of an evidenced-based community health worker home visiting program grounded in extensive patient and community participation. Research Project 2 will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities. These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity care.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trial with one arm.
| Arm | Type | Receives |
|---|---|---|
| PEN-3 Assessment Model | Other | Behavioral: The PEN-3 Intervention ModelApplication of a sociocultural model to assess patient-clinical linkages that support positive maternal health outcomes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Identified as high risk pregnancy
- Postpartum mothers/parents 18-45 years
- Resident of the one of 5 target counties (Washington, Bolivar, Scott, Humphreys, and Carroll)
- Maternal healthcare providers in target counties
- Maternal community health leaders
Key exclusion criteria (4 listed)
- not identified as high risk pregnancy
- 18 years of age postpartum
- cesarean birth
- non-resident of the 5 target counties
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 |
|---|---|---|
| The PEN-3 Intervention ModelThe PEN-3 Model is a sociocultural model for planning and assessing participant behavior within the context a cultural phenomenon. It will be used to assess intervention impact on patient-clinical linkages in the Mississippi Delta. | Behavioural | PEN-3 Assessment Model |
Primary outcome
Improve trust in the healthcare system
Time frame: 12 months from consent to participate
Mixed methods approach using Trust in Physician Scale \& Researcher developed qualitative tool
Increase maternal health literacy (patient and provider perspectives)
Time frame: 12 months from consent to participate in the intervention
Brief literacy screening tool to evaluate health literacy in the health system (Qualitative and Quantitative Measures
Increase engagement in the maternal health care system (patient-clinic linkages)
Time frame: 12 month from consent to participation in the intervention
Contraceptive Counseling measure tool to evaluate the patient experiences with provider care and vice-versa; minimally 2 post-partum clinec visits in postpartum period
Strengthen structuring of family support systems
Time frame: 12 months from consent to participation in the intervention
Family crisis coping response (F-COPES) measure to determine patient (mother) and family perceptions and experiences with structuring family support fo postpartum care period.
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 8 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Mary Shaw, PhD principal investigator
Jackson State University
Mary Shaw, PHD, M.ED study director
Jackson State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The PEN-3 Intervention Model in people with Family Dynamics and Trust in Healthcare System, run by Jackson State University at 1 site in United States.
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 5 inclusion and 4 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 8 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 United States. 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. 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 Mary Shaw, PhD (601-979-3103, mary.shaw@jsums.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve trust in the healthcare system (time frame: 12 months from consent to participate). 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 8 Jun 2026.