Breastfeeding Clinical Trial
Official title:
Doula Support for Young Mothers: A Randomized Trial
The goal of this study was to evaluate the impact of a doula home visiting intervention on young, low-income mothers' birth outcomes, breastfeeding, postpartum depressive symptoms, and parenting, and on their children's development.
The goal of this study is to evaluate a doula home visiting model -- sometimes called the
"community doula model." This model differs from typical hospital based doula interventions
in several ways. Doulas are providers from the same community backgrounds as their clients.
Services are not just provided during labor and delivery, but throughout the final trimester
and during the first weeks after delivery. Prenatal and postpartum services are provided in
the homes of the mothers. The model was developed specifically for working with low-income
mothers and with young mothers.
A two-armed randomized controlled trial was conducted at the University of Chicago
Hospitals. Participants were recruited through two out-patient obstetric clinics affiliated
with the Hospitals. The clinics primarily served a low-income, African-American population,
reflective of the families in the communities near to the hospital. The study was open to
all young women receiving prenatal care at the clinics who met age and eligibility criteria.
After providing informed consent and completing a baseline interview, participants were
randomized into two groups. The experimental group, in addition to receiving regular
clinical care, received weekly home visiting services from a doula and the support of a
doula at the hospital during labor and delivery. Doulas worked with their clients until
three months postpartum. The control group received standard clinical care and had access to
social work case management.
Four paraprofessional doulas delivered the study intervention. Before providing study
services, doulas had been trained to provide childbirth education, labor support,
breastfeeding education, and parent-child interaction support.
Followup research assessments of the doula and control group mothers and infants were
conducted during the first three days postpartum, at 4 months postpartum, at 12 months
postpartum, and at 24 months postpartum. 80% of the sample was retained through the 24 month
followup assessment. Follow up assessments involved interviews with the mothers, videotaping
of mother-infant interaction, and behavioral assessment of the infants. Obstetric and
newborn hospital medical charts were also reviewed.
The study evaluated outcomes that have been the focus of prior studies of hospital-only
doula services: use of obstetrical intervention in labor and delivery (anesthesia, surgical
delivery), mother labor efficacy, breastfeeding, and maternal depression. A major
contribution of this study is to explore longer term outcomes not evaluated in prior studies
of doula intervention, particularly parenting and child development outcomes. The study
evaluated multiple dimensions of parenting including parenting behavior (sensitivity,
stimulation), parenting efficacy, parenting attitudes, and parenting stress. Child
development outcomes included cognitive development and early behavior problems.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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