Doula Home Visiting Randomized Trial

The University of Chicago

Status: Completed

Conditions: Breast Feeding; Child Development; Parenting; Depression, Postpartum

Treatments: Behavioral: Case management; Behavioral: Doula Home Visiting

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01947244

D89MC23146

Details and patient eligibility

About

The purpose of this randomized controlled trial is to examine whether evidence-based home visiting programs enhanced by doula services have effects on positive parenting practices, breastfeeding, and child and maternal health outcomes.

Full description

The goal of this study is to evaluate the impact of doula enhanced evidence-based home visiting programs for young mothers in Illinois. Mothers in the intervention group receive home visits from doulas during pregnancy and in the first few weeks postpartum, and doulas provide mothers with support at the hospital during labor, delivery, and with early breastfeeding. Additionally, mothers in the intervention group receive prenatal and long-term postpartum home visitation services through an evidence-based home visiting program, such as Parents as Teachers and Healthy Families Illinois. Mothers in the comparison group receive a less intensive case management service.

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.

Enrollment: 312 patients

Sex: Female

Ages: 14 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pregnant and between 12 and 34 weeks gestation
• live within the catchment area of a program site
• between ages of 14-24
• English or Spanish speaking

Exclusion criteria

• ward of the Department of Children and Family Services (DCFS)
• under supervision of juvenile justice system
• planning to give up custody of infant
• pregnancy result of sexual assault

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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312 participants in 2 patient groups

Doula Home Visiting

Experimental group

Description:

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.

Treatment:

Behavioral: Doula Home Visiting

Case Management

Active Comparator group

Description:

Mothers in the comparison group receive low intensity case management services during pregnancy and following the birth.

Treatment:

Behavioral: Case management