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 — BEHAVIORAL
    The 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 Care
    Participants will receive usual clinical care with a baby admitted to the Neonatal Intensive Care Unit
  • Experimental: Enhanced doula support
    The 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

Locations (1)

FacilityCityStateZIPSite coordinators
Women and Infants HospitalProvidenceRhode Island02905
Research Assistant
401-274-1122
Alisse Hauspurg, MD (PRINCIPAL_INVESTIGATOR)

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