[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654499":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":47,"studyPopulation":37,"armGroups":48,"interventions":60,"overallOfficials":37,"centralContacts":37,"locations":68,"responsibleParty":94,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":37,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":127,"overallStatus":70,"whyStopped":37,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"University of Florida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluating the Effectiveness of UNITE Intervention","The primary outcome is a composite measure of perinatal depressive and\u002For 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.","4-6 weeks postpartum",[14,18,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"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.","Baseline (14-28 weeks gestation), 32-36 weeks gestation, 4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum",{"measure":19,"description":20,"timeFrame":17},"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.",{"measure":22,"description":23,"timeFrame":17},"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.",{"measure":25,"description":26,"timeFrame":17},"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.",{"measure":28,"description":29,"timeFrame":17},"Medical Mistrust","Medical mistrust will be assessed using the Group-Based Medical Mistrust Scale (GBMMS), a 12-item scale assessing perceptions of trustworthiness of doctors and healthcare workers toward one's ethnic group, rated on a 5-point scale (Strongly disagree to Strongly agree). Total scores range from 12 to 60, with higher scores indicating greater medical mistrust.",{"measure":31,"description":32,"timeFrame":12},"Birth Experience","Birth experience will be assessed using the Childbirth Experience Questionnaire (CEQ), a 22-item measure covering four domains: Own Capacity, Professional Support, Perceived Safety, and Participation. Items are rated on a 4-point scale (1=strongly disagree\u002Fmost negative to 4=strongly agree\u002Fmost positive), with 11 items reverse-scored. Each domain is scored as a mean ranging from 1 to 4, with higher scores indicating a more positive childbirth experience.",{"measure":34,"description":35,"timeFrame":36},"Breastfeeding Rates","Breastfeeding practices will be assessed using a study-adapted CDC Breastfeeding questionnaire, capturing participants who ever breastfed or fed pumped breast milk, currently breastfeeding at each assessment, and breastfeeding duration in weeks\u002Fmonths.","4-6 weeks postpartum, 3 months (±2 weeks) postpartum, and 9-12 months postpartum",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":37,"timePerspective":37,"maskingInfo":43},"RANDOMIZED","PARALLEL","A pragmatic two-armed Type 1 Effectiveness-Implementation Hybrid Randomized Controlled Trial (RCT)","SUPPORTIVE_CARE",{"masking":44,"maskingDescription":37,"whoMasked":45},"SINGLE",[46],"OUTCOMES_ASSESSOR","Women in the US have not reaped the benefits of the decline in worldwide maternal mortality (MM) rates (maternal deaths per 100,000 live births) as pregnancy-related deaths (death of a woman while pregnant or within 1 year of the end of a pregnancy) have increased steadily for the past 3 decades. The incidence of perinatal depression and anxiety disorders is high in the US. An estimated 1 out of 7 to 10 pregnant women and 1 out of 5 to 8 postpartum women will develop depressive and\u002For anxiety disorder.\n\nA doula is a non-medical person who provides informational, physical and emotional support to patients and their support persons. The support doulas provide may be instrumental in supporting maternal wellbeing and navigation of the healthcare system to obtain needed medical care. However, research on doulas have focused primarily on pregnancy and birth. Evidence as to the effectiveness of doula care in the postpartum is scant. This proposal will contribute to the sparse high-level evidence to support the use and expansion of doula services to improve health for low-income families.\n\nThis is a pragmatic, two-arm, Type 1 Effectiveness-Implementation Hybrid randomized controlled trial evaluating an enhanced doula support model, UNITE, against standard Medicaid covered doula care, in a socially high-risk population. Pregnant individuals in the study catchment area will be randomized to one of two groups: standard Medicaid doula care, or UNITE doula care, which adds more visits starting earlier in pregnancy, more frequent visits near the due date, several extended home visits in the first two months postpartum, and continued check-ins through the first year after birth. UNITE participants will be engaged in clinic or home settings, in person and\u002For virtually, and will receive emotional and physical support, education, referrals to community resources, and screening for risk factors for adverse outcomes.\n\nThe study also builds the doula workforce it depends on. Through the UNITE Doula Collective, doulas are trained, supported to bill Medicaid, and mentored by an experienced doula network.\n\nParticipants in both arms will complete surveys at five time points from pregnancy through one year postpartum to assess the intervention's effectiveness. The primary outcome is a composite measure of perinatal depressive and anxiety symptoms. Secondary outcomes include psychosocial measures, maternal morbidity and mortality, clinical and birth outcomes, and knowledge of pregnancy warning signs. Implementation outcomes include reach, adoption, fidelity, and adaptation, will also be assessed.\n\nA nested qualitative component, including doula group debriefings and in-depth interviews with doula-client dyads, will contextualize the RCT findings.\n\nThe study is led by two Community Advisory Board (CAB), 1) Service Recipients - Women of childbearing age, partners\u002F support persons, and 2) Service Providers - doulas, medical personnel (midwifery, obstetrics, primary care, mental health), community representatives, and policy makers. The CABs meet quarterly throughout the study.\n\nFindings are intended to inform a communication campaign and a state-level policy on Medicaid reimbursement and the extension of doula services into the postpartum period.",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"Enhanced Doula Support","ACTIVE_COMPARATOR","Participants with Medicaid insurance will receive an enhanced doula support, which adds more visits starting earlier in pregnancy, more frequent visits near the due date, several extended home visits in the first two months postpartum, and continued check-ins through the first year after birth.",[54],"Other: Doula",{"label":56,"type":6,"description":57,"interventionNames":58},"Standard Medicaid Doula Support","Participants with Medicaid insurance will receive standard Medicaid doula support only.",[59],"Other: Standard (non-enhanced) Medicaid doula support",[61,65],{"type":6,"name":62,"description":63,"armGroupLabels":64,"otherNames":37},"Doula","Enhanced doula support in the post-partum period.",[50],{"type":6,"name":66,"description":66,"armGroupLabels":67,"otherNames":37},"Standard (non-enhanced) Medicaid doula support",[56],[69],{"facility":5,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"RECRUITING","Gainesville","Florida","32610","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-82.32483,29.65163,{"lat":80,"lon":79},[83,88,91],{"name":84,"role":85,"phone":86,"phoneExt":37,"email":87},"Clinical Research Manager","CONTACT","352-665-5255","ALJLAB@ad.ufl.edu",{"name":89,"role":85,"phone":86,"phoneExt":37,"email":90},"Director of Doula Programs","jrainer@ufl.edu",{"name":92,"role":93,"phone":37,"phoneExt":37,"email":37},"Adetola Louis-Jacques, MD","PRINCIPAL_INVESTIGATOR",{"type":95,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[97],{"name":98,"class":99},"National Institute of Nursing Research (NINR)","NIH","100654499","deconstructing-maternal-burdens-doulas-and-the-community-unite-for-health-100654499",false,"NCT07799805","Deconstructing Maternal Burdens: Doulas and the Community Unite for Health","UNITE","Inclusion Criteria:\n\n* 15-49 years old\n* 14-28 weeks pregnant\n* Medicaid Eligible\n* Resides in North Central Florida\n\nExclusion Criteria:\n\n* Severe physical or mental health conditions that Interfere with participation","FEMALE","15 Years","49 Years",{"count":111,"type":112},516,"ESTIMATED","INTERVENTIONAL",[115],"NA","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.\n\nThe study also builds the doula workforce needed to sustain this model of care, training doulas to become eligible to bill Medicaid for their services.\n\nThe 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.",[118,119,120,121,122,123,124,125,126],"Pregnancy","Post Partum","Doula Care","Postpartum Depression (PPD)","Perinatal Depression","Perinatal Anxiety","Health Disparities","Pregnancy Complications","Maternal Adverse Outcomes",[118,62,128,119,129],"Medicaid","Pregnancy Support","2026-09-24",{"date":132,"type":133},"2026-09-28","ACTUAL",{"date":135,"type":112},"2026-09-15",{"date":137,"type":112},"2029-11-30",{"name":5,"class":6},1]