NCT07437131

Community-Partnered Doula Support for Neonatal Intensive Care Unit Families

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

One in eight babies are admitted to the Neonatal Intensive Care Unit (NICU) in Rhode Island due to pregnancy or neonatal complications. Approximately half of NICU parents experience clinically significant levels of depression, anxiety and trauma. Structural and institutional barriers and unmet health-related social needs limit healthcare access, adversely impacting outcomes in NICU families. Innovative solutions to support NICU families are urgently needed. Doula care is recommended by The Department of Health and Human Services to provide emotional, physical, and informational support and advocacy. Despite the vulnerability of NICU families, doula care has not been trialed in the NICU setting. The overall goal of this line of research is to address the challenges that families face in the NICU through our novel community-partnered doula intervention. In this application, the objective is to conduct a single-site type 1 hybrid effectiveness-implementation pilot study of a NICU-based parental doula care program. This will be achieved through two specific aims: (1) to evaluate whether enhanced doula care compared to treatment as usual in NICU families, improves parental stress and (2) To conduct a summative evaluation of the implementation of doula care in the NICU. Our central hypothesis is that doula care rooted will improve parental emotional and physical health outcomes with NICU infants. The research proposed in this application is innovative as it provides the first rigorous evidence for incorporating community-partnered doula care into the NICU setting. This proposal is significant as it will adapt an evidence-based, multi-level approach to improve outcomes and meet the needs of high-risk NICU families. The investigators anticipate that our evidence-based, community-driven approach will be a first step towards a scalable, and sustainable strategy to improve health outcomes for NICU families. Our findings will provide a valuable framework to generate data to support a subsequent large-scale randomized trial of enhanced doula support in NICU families, incorporating a proposed community co-leadership model. Through evaluation of implementation, the investigators will gather critical data to inform implementation strategies to scale doula care in the NICU. These innovations in care practices will provide a rigorous evidence base to further develop and support community partnerships in other NICUs, and to advocate for spread of legislation needed to sustain such interventions across the United States to benefit all Americans.

Conditions

• Infant Admitted to Neonatal Intensive Care Unit (NICU)
• Doula Support

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2026-03-10
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-02-27
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States