Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
312 participants
INTERVENTIONAL
2011-11-30
2019-10-31
Brief Summary
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Detailed Description
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Four existing doula home visiting programs located in economically distressed communities in Illinois were selected for participation in the study. At each site, young pregnant women are recruited for participation in the study, provide informed consent, and complete a baseline interview in their homes during mid-pregnancy. At completion of the baseline interview, mothers are randomly assigned to either the doula home visiting intervention group or the case management comparison group.
At 37 weeks of pregnancy, and at 3 weeks-, 3 months-, 13 months-, and 30 months, and 4 years postpartum, mothers are interviewed in their homes on topics including pregnancy, parenting, health, mental health, feeding practices, employment/education, and relationships. Additionally, at all postpartum visits, mothers are videorecorded interacting with their infants. At the 13 month, 30 month, and 4 year followup sessions, children of the study participants are administered developmental and behavioral assessments.
Based on prior studies of doula services and the goals of doula enhanced home visiting programs, a variety of outcomes are assessed at followup time points. These outcomes include prenatal medical care, prenatal bonding with infant, feelings of efficacy during labor, anesthesia use during labor, breastfeeding, positive parenting behaviors, parenting attitudes and stress, infant health, maternal health, maternal depressive symptoms, and child behavior and development.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Doula Home Visiting
Participants assigned to the intervention group receive prenatal and short-term postpartum home visitation from doulas, and support from doulas at the hospital during labor, delivery, and with early breastfeeding. Additionally, these participants receive longer-term home visiting services from family support workers during pregnancy and after the birth.
Doula Home Visiting
The intervention is a doula enhancement to evidence-based home visiting services. Doulas provide home visits during pregnancy and for the first six weeks postpartum, which focus on prenatal health, preparation for childbirth, bonding with the baby, and breastfeeding education. Family support workers provide longer term home visiting services. These home visits focus on sensitive and responsive parenting, early infant care, bonding with the baby, child health and development, and maternal mental health.
Case Management
Mothers in the comparison group receive low intensity case management services during pregnancy and following the birth.
Case management
Mothers are offered two prenatal and two postpartum case management meetings to assess whether mothers' basic needs (housing, nutrition, health care, mental health) are being met and make appropriate referrals.
Interventions
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Doula Home Visiting
The intervention is a doula enhancement to evidence-based home visiting services. Doulas provide home visits during pregnancy and for the first six weeks postpartum, which focus on prenatal health, preparation for childbirth, bonding with the baby, and breastfeeding education. Family support workers provide longer term home visiting services. These home visits focus on sensitive and responsive parenting, early infant care, bonding with the baby, child health and development, and maternal mental health.
Case management
Mothers are offered two prenatal and two postpartum case management meetings to assess whether mothers' basic needs (housing, nutrition, health care, mental health) are being met and make appropriate referrals.
Eligibility Criteria
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Inclusion Criteria
* live within the catchment area of a program site
* between ages of 14-24
* English or Spanish speaking
Exclusion Criteria
* under supervision of juvenile justice system
* planning to give up custody of infant
* pregnancy result of sexual assault
14 Years
24 Years
FEMALE
No
Sponsors
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Health Resources and Services Administration (HRSA)
FED
Illinois Department of Human Services
UNKNOWN
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Sydney L Hans, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Chicago, School of Social Service Administration
References
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Hans SL, Edwards RC, Zhang Y. Randomized Controlled Trial of Doula-Home-Visiting Services: Impact on Maternal and Infant Health. Matern Child Health J. 2018 Oct;22(Suppl 1):105-113. doi: 10.1007/s10995-018-2537-7.
Hans SL, Edwards RC, Zhang Y. Correction to: Randomized Controlled Trial of Doula-Home-Visiting Services: Impact on Maternal and Infant Health. Matern Child Health J. 2018 Oct;22(Suppl 1):125. doi: 10.1007/s10995-018-2626-7.
Edwards RC, Vieyra Y, Hans SL. Maternal support for infant learning: Findings from a randomized controlled trial of doula home visiting services for young mothers. Early Childhood Research Quarterly. 2020; 51: 26-38.
Other Identifiers
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D89MC23146
Identifier Type: -
Identifier Source: org_study_id