Community-Partnered Doula Support for Neonatal Intensive Care Unit Families
1 other identifier
interventional
60
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2026
CompletedFirst Submitted
Initial submission to the registry
February 20, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 3, 2026
February 1, 2026
10 months
February 20, 2026
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maternal stress
Maternal stress as measured by perceived stress scale (PSS): NICU (range: 0-230, higher score indicates worse outcome)
6 weeks
Secondary Outcomes (7)
Mean arterial pressure
6 weeks
Diastolic blood pressure
6 weeks
Systolic blood pressure
6 weeks
Anxiety
6 weeks
Depression
6 weeks
- +2 more secondary outcomes
Study Arms (2)
Standard Care
NO INTERVENTIONParticipants will receive usual clinical care with a baby admitted to the Neonatal Intensive Care Unit
Enhanced doula support
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- baby admitted to NICU at Women and Infants Hospital
- anticipated NICU stay greater than or equal to 2 weeks
- English or Spanish speaking
You may not qualify if:
- Infant anticipated stay \< 2 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2026
First Posted
February 27, 2026
Study Start
February 15, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 3, 2026
Record last verified: 2026-02