Community-Partnered Doula Support for Neonatal Intensive Care Unit Families
Part of paid clinical trials in Providence, Rhode Island.
- Sponsor
- Women and Infants Hospital of Rhode Island
- Study ID
- NCT07437131
- Status
- Recruiting
Conditions
- Doula Support
- Infant Admitted to Neonatal Intensive Care Unit (NICU)
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Enhanced doula support — BEHAVIORALThe doula intervention will be delivered by a dedicated postpartum NICU doula. The postpartum doula will provide one-on-one support at least weekly for a period of six weeks, to intensively engage and support participants, reinforce health behavior education, and screen for and help families to access quality medical care, mental health and social needs support.
Study Details
The goal of this clinical trial is to learn if pairing families who have a baby in the Neonatal Intensive Care Unit with a community doula improves stress. The main questions it aims to answer are: Researchers will compare stress levels among families with a baby in the neonatal intensive care unit who are paired with a community doula compared to those who receive standard care. Participants will: Complete baseline surveys and physical assessments (blood pressure and blood sample collection) and again after six weeks If they are randomized to receive doula support, they will meet with the doula weekly to receive additional parental support for six weeks
Key Dates
- Start date
- Mar 10, 2026
- Status verified
- Mar 2026
- Primary completion
- Dec 1, 2026
- Completion
- Dec 1, 2026
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- No Intervention: Standard CareParticipants will receive usual clinical care with a baby admitted to the Neonatal Intensive Care Unit
- Experimental: Enhanced doula supportThe doula intervention will be delivered by a dedicated postpartum NICU doula. The postpartum doula will provide one-on-one support at least weekly for a period of six weeks, to intensively engage and support participants, reinforce health behavior education, and screen for and help families to access quality medical care, mental health and social needs support.
Primary Outcome Measure
Maternal stress [ Time Frame: 6 weeks ]
Central Contacts
- Alisse Hauspurg, MD401-274-1122
- Sarbattama Sen, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Women and Infants Hospital | Providence | Rhode Island | 02905 | Alisse Hauspurg, MD (PRINCIPAL_INVESTIGATOR) |