This study is a randomized controlled trial comparing two models of doula support for pregnant individuals enrolled in Medicaid: an enhanced doula support model, in which support starts earlier in pregnancy, occurs more frequently, and continues through the first year after birth, versus the standard doula care currently covered by Medicaid in Florida.
The study also builds the doula workforce needed to sustain this model of care, training doulas to become eligible to bill Medicaid for their services.
The primary goal is to determine whether the enhanced doula model results in significantly lower rates of perinatal depressive and anxiety symptoms compared to standard doula support, while gathering data on real-world implementation. The study also evaluates the effectiveness of Medicaid-covered doula services more broadly, with findings intended to inform state-level policy on Medicaid reimbursement and the extension of doula services into the postpartum period.
15-49 years old
14-28 weeks pregnant
Medicaid Eligible
Resides in North Central Florida
Severe physical or mental health conditions that Interfere with participation
Parallel
Doula
Other interventionEnhanced doula support in the post-partum period.
Standard (non-enhanced) Medicaid doula support
Other interventionStandard (non-enhanced) Medicaid doula support
Evaluating the Effectiveness of UNITE Intervention
The primary outcome is a composite measure of perinatal depressive and/or anxiety symptoms. Depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), with a score greater than 9 indicating clinically significant symptoms; the EPDS ranges from 0 to 30, with higher scores indicating greater severity of depressive symptoms. As well as the Generalized Anxiety Disorder 7-item Scale (GAD-7), ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
Perinatal Depressive Symptoms
Depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), the EPDS ranges from 0 to 30, with higher scores indicating greater severity of depressive symptoms. Longitudinal models will allow comparison of trends over time in mean depressive symptom scores and inferences at specific time points.
Perinatal Anxiety Symptoms
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item Scale (GAD-7), which ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms. Longitudinal models will allow comparison of trends over time in mean anxiety scores and inferences at specific time points.
Perceived Stress
Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10), administered at all time points. The PSS-10 ranges from 0 to 40, with higher scores indicating greater perceived stress.
Social Support
The Medical Outcomes Study Social Support Survey (MOS-SSS) is a 19-item self-administered survey, with items rated on a 5-point scale. Scores are transformed to a 0-to-100 scale, where higher scores represent higher, better perceived social support.
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
