Doula Support for Young Mothers: A Randomized Trial

Not Applicable

Completed

• Conditions: Parenting; Breastfeeding; Depression, Postpartum
• Interventions: Behavioral: Doula

• Registration Number: NCT01925664
• Lead Sponsor: University of Chicago

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-16
• Study First Posted: 2013-08-20
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 248

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doula	Doula	Mothers received doula home visiting services in addition to normal prenatal and obstetric clinical care and had access to social work case management.

Primary Outcome Measures

Name	Time	Method
Positive parenting behavior (Parent Child Observation Guide)	4 months postpartum	Videotaped interactions between mothers and infants coded by masked observers
Breastfeeding Initiation	Three days postpartum

Secondary Outcome Measures

Name	Time	Method
Parenting Stress Index (PSI)	4-, 12-, and 24 months postpartum	The PSI is a self report scale that measures parenting stress and parent perceptions of the difficulty of her child
Breastfeeding duration	4- and 12 months postpartum
Positive parenting behaviors (Parent Child Observation Guide)	12- and 24 months postpartum	Videotaped interactions between mothers and infants coded by masked observers
Center for Epidemiologic Studies Depression Scale (CES-D)	4-, 12-, and 24 months postpartum	The CES-D is a self report scale that measures depressive symptoms experienced in the prior week.
Timing of solid food introduction to infant	4- and 12 months postpartum
Mullen Scales of Early Learning	24 months postpartum	The Mullen is an assessment tool that measures child motor, cognitive, and language development. Trained assessors administered the instrument to the toddlers of study mothers.
Use of labor anesthesia	Start of labor through childbirth
Labour Agentry Scale	1 day postpartum	The Labour Agentry Scale is a self-report scale that assesses maternal feelings of efficacy during labor
Adult Adolescent Parenting Inventory (AAPI)	4 months postpartum	The AAPI is a self report scale that measures appropriate parenting attitudes
Maternal Self-Efficacy Scale	4-, 12-, and 24 months postpartum	The Maternal Self-Efficacy Scale is a self report scale that measures parenting efficacy with regard to infant care.
The Brief Infant Toddler Social Emotional Assessment (BITSEA)	12- and 24 months postpartum	The BITSEA is a parent report measure that assesses problem behaviors and social competence in infants and toddlers.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States