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Doula Support for Young Mothers: A Randomized Trial

Primary Purpose

Parenting, Breastfeeding, Depression, Postpartum

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Doula
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parenting focused on measuring Doulas, Parenting, Breastfeeding, Pregnancy in Adolescence

Eligibility Criteria

14 Years - 21 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Doula

Usual Care

Arm Description

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

Mothers received normal prenatal and obstetric clinical care and had access to social work case management.

Outcomes

Primary Outcome Measures

Breastfeeding Initiation
Positive parenting behavior (Parent Child Observation Guide)
Videotaped interactions between mothers and infants coded by masked observers

Secondary Outcome Measures

Breastfeeding duration
Positive parenting behaviors (Parent Child Observation Guide)
Videotaped interactions between mothers and infants coded by masked observers
Use of labor anesthesia
Labour Agentry Scale
The Labour Agentry Scale is a self-report scale that assesses maternal feelings of efficacy during labor
Adult Adolescent Parenting Inventory (AAPI)
The AAPI is a self report scale that measures appropriate parenting attitudes
Maternal Self-Efficacy Scale
The Maternal Self-Efficacy Scale is a self report scale that measures parenting efficacy with regard to infant care.
Parenting Stress Index (PSI)
The PSI is a self report scale that measures parenting stress and parent perceptions of the difficulty of her child
Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D is a self report scale that measures depressive symptoms experienced in the prior week.
Timing of solid food introduction to infant
The Brief Infant Toddler Social Emotional Assessment (BITSEA)
The BITSEA is a parent report measure that assesses problem behaviors and social competence in infants and toddlers.
Mullen Scales of Early Learning
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.

Full Information

First Posted
August 14, 2013
Last Updated
September 4, 2013
Sponsor
University of Chicago
Collaborators
HRSA/Maternal and Child Health Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT01925664
Brief Title
Doula Support for Young Mothers: A Randomized Trial
Official Title
Doula Support for Young Mothers: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
HRSA/Maternal and Child Health Bureau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenting, Breastfeeding, Depression, Postpartum
Keywords
Doulas, Parenting, Breastfeeding, Pregnancy in Adolescence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doula
Arm Type
Experimental
Arm Description
Mothers received doula home visiting services in addition to normal prenatal and obstetric clinical care and had access to social work case management.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Mothers received normal prenatal and obstetric clinical care and had access to social work case management.
Intervention Type
Behavioral
Intervention Name(s)
Doula
Intervention Description
This intervention included doulas providing weekly home visits during the last trimester of pregnancy and up to three months postpartum. Home visits focused on prenatal health, preparation for childbirth, breastfeeding education, and developing a relationship with the baby. Doulas also were present in the hospital during labor, delivery, and postpartum providing emotional support, non-medical comfort measures, and breastfeeding counseling.
Primary Outcome Measure Information:
Title
Breastfeeding Initiation
Time Frame
Three days postpartum
Title
Positive parenting behavior (Parent Child Observation Guide)
Description
Videotaped interactions between mothers and infants coded by masked observers
Time Frame
4 months postpartum
Secondary Outcome Measure Information:
Title
Breastfeeding duration
Time Frame
4- and 12 months postpartum
Title
Positive parenting behaviors (Parent Child Observation Guide)
Description
Videotaped interactions between mothers and infants coded by masked observers
Time Frame
12- and 24 months postpartum
Title
Use of labor anesthesia
Time Frame
Start of labor through childbirth
Title
Labour Agentry Scale
Description
The Labour Agentry Scale is a self-report scale that assesses maternal feelings of efficacy during labor
Time Frame
1 day postpartum
Title
Adult Adolescent Parenting Inventory (AAPI)
Description
The AAPI is a self report scale that measures appropriate parenting attitudes
Time Frame
4 months postpartum
Title
Maternal Self-Efficacy Scale
Description
The Maternal Self-Efficacy Scale is a self report scale that measures parenting efficacy with regard to infant care.
Time Frame
4-, 12-, and 24 months postpartum
Title
Parenting Stress Index (PSI)
Description
The PSI is a self report scale that measures parenting stress and parent perceptions of the difficulty of her child
Time Frame
4-, 12-, and 24 months postpartum
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
The CES-D is a self report scale that measures depressive symptoms experienced in the prior week.
Time Frame
4-, 12-, and 24 months postpartum
Title
Timing of solid food introduction to infant
Time Frame
4- and 12 months postpartum
Title
The Brief Infant Toddler Social Emotional Assessment (BITSEA)
Description
The BITSEA is a parent report measure that assesses problem behaviors and social competence in infants and toddlers.
Time Frame
12- and 24 months postpartum
Title
Mullen Scales of Early Learning
Description
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.
Time Frame
24 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sydney L Hans, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24187119
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.
Results Reference
derived

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Doula Support for Young Mothers: A Randomized Trial

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