Community-Partnered Doula Support for Neonatal Intensive Care Unit Families

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

Study Overview

• Status: Recruiting
• Conditions: Infant Admitted to Neonatal Intensive Care Unit (NICU); Doula Support
• Intervention / Treatment: Behavioral: Enhanced doula support

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alisse Hauspurg, MD; Phone Number: 47451 401-274-1122; Email: ahauspurg@carene.org
• Study Contact Backup: Name: Sarbattama Sen, MD; Email: ssen@carene.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Recruiting
      • Women and Infants Hospital
      • Principal Investigator: Alisse Hauspurg, MD
      • Contact: Research Assistant; Phone Number: 401-274-1122; Email: nicudoulas@wihri.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• baby admitted to NICU at Women and Infants Hospital
• anticipated NICU stay greater than or equal to 2 weeks
• English or Spanish speaking

Exclusion Criteria:

• Infant anticipated stay < 2 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal stress	Maternal stress as measured by perceived stress scale (PSS): NICU (range: 0-230, higher score indicates worse outcome)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial pressure	Mean arterial blood pressure	6 weeks
Diastolic blood pressure	Mean diastolic blood pressure	6 weeks
Systolic blood pressure	Mean systolic blood pressure	6 weeks
Anxiety	Anxiety as measured by Generalized Anxiety Disorder-7 (GAD-7) (range: 0-21, higher score indicates worse outcome)	6 weeks
Depression	Depression as measured by Edinburgh Postnatal Depression Scale (EPDS) (range: 0-30, higher score indicates worse outcome)	6 weeks
Experiences of care	Experience of care as measured by Family-Centered Care Scale in Neonatal Intensive Care Unit (FCCS-NICU) (range: 1-5, lower score indicates worse outcome)	6 weeks
Post-traumatic stress	Post-traumatic stress scores measured by Modified Perinatal Post-traumatic Stress Disorder Questionnaire (PPQ-II) (range: 0-56, higher score indicates a worse outcome)	6 weeks

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: NICU, infant in NICU; doula support
• Other Study ID Numbers: WIH 25-0026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No