Community-Partnered Doula Support for Neonatal Intensive Care Unit Families
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enhanced doula support.
- Who it may be relevant to
- Registry conditions: Infant Admitted to Neonatal Intensive Care Unit (NICU), Doula Support. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Maternal stress [Time frame: 6 weeks]
Secondary outcome measures (7)
- Mean arterial pressure [Time frame: 6 weeks]
- Diastolic blood pressure [Time frame: 6 weeks]
- Systolic blood pressure [Time frame: 6 weeks]
- Anxiety [Time frame: 6 weeks]
- Depression [Time frame: 6 weeks]
- Experiences of care [Time frame: 6 weeks]
- Post-traumatic stress [Time frame: 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Women and Infants Hospital — Providence
Identifiers
NCT: NCT07437131 · WIH 25-0026