Clinical trial NCT01925664: Doula Support for Young Mothers: A Randomized Trial
Official title: Doula Support for Young Mothers: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Breastfeeding
Depression, Postpartum
Keywords: Doulas
Parenting
Breastfeeding
Pregnancy in Adolescence
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2013-08-20
Enrollment: 248
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* pregnant and less than 34 weeks gestation
* planning to deliver at study hospital
* between ages 14 and 21

Exclusion Criteria:

* planning to move out of community after giving birth
* planning to give up custody of infant
* prior c-section delivery

Primary outcomes:
measure: Breastfeeding Initiation
timeFrame: Three days postpartum
measure: Positive parenting behavior (Parent Child Observation Guide)
timeFrame: 4 months postpartum
Secondary outcomes:
measure: Breastfeeding duration
timeFrame: 4- and 12 months postpartum
measure: Positive parenting behaviors (Parent Child Observation Guide)
timeFrame: 12- and 24 months postpartum
measure: Use of labor anesthesia
timeFrame: Start of labor through childbirth
measure: Labour Agentry Scale
timeFrame: 1 day postpartum
measure: Adult Adolescent Parenting Inventory (AAPI)
timeFrame: 4 months postpartum
measure: Maternal Self-Efficacy Scale
timeFrame: 4-, 12-, and 24 months postpartum
measure: Parenting Stress Index (PSI)
timeFrame: 4-, 12-, and 24 months postpartum
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 4-, 12-, and 24 months postpartum
measure: Timing of solid food introduction to infant
timeFrame: 4- and 12 months postpartum
measure: The Brief Infant Toddler Social Emotional Assessment (BITSEA)
timeFrame: 12- and 24 months postpartum
measure: Mullen Scales of Early Learning
timeFrame: 24 months postpartum
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Sydney L Hans, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edwards RC, Thullen MJ, Korfmacher J, Lantos JD, Henson LG, Hans SL. Breastfeeding and complementary food: randomized trial of community doula home visiting. Pediatrics. 2013 Nov;132 Suppl 2:S160-6. doi: 10.1542/peds.2013-1021P.