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NCT Number: NCT07437131

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location status: Recruiting

Location contact

Alisse Hauspurg, MD

PRINCIPAL_INVESTIGATOR

Research Assistant

CONTACT

[email protected]

401-274-1122

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Maternal stress

    Time frame: 6 weeks

    Maternal stress as measured by perceived stress scale (PSS): NICU (range: 0-230, higher score indicates worse outcome)

Secondary outcomes

  1. Mean arterial pressure

    Time frame: 6 weeks

    Mean arterial blood pressure

  2. Diastolic blood pressure

    Time frame: 6 weeks

    Mean diastolic blood pressure

  3. Systolic blood pressure

    Time frame: 6 weeks

    Mean systolic blood pressure

  4. Anxiety

    Time frame: 6 weeks

    Anxiety as measured by Generalized Anxiety Disorder-7 (GAD-7) (range: 0-21, higher score indicates worse outcome)

  5. Depression

    Time frame: 6 weeks

    Depression as measured by Edinburgh Postnatal Depression Scale (EPDS) (range: 0-30, higher score indicates worse outcome)

  6. Experiences of care

    Time frame: 6 weeks

    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)

  7. Post-traumatic stress

    Time frame: 6 weeks

    Post-traumatic stress scores measured by Modified Perinatal Post-traumatic Stress Disorder Questionnaire (PPQ-II) (range: 0-56, higher score indicates a worse outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Alisse Hauspurg, MD

CONTACT

[email protected]

401-274-1122 ext. 47451

Sarbattama Sen, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.