Doula Support for Young Mothers: A Randomized Trial

Breastfeeding Clinical Trial

Official title:

Doula Support for Young Mothers: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925664
• Other study ID #: R40 MC 00203
• Status: Completed
• Phase: N/A
• First received: August 14, 2013
• Last updated: September 4, 2013
• Start date: January 2001
• Est. completion date: August 2006

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breastfeeding
• Depression, Postpartum
• Parenting

Intervention

Behavioral:
• Doula
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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding Initiation		Three days postpartum	No
Primary	Positive parenting behavior (Parent Child Observation Guide)	Videotaped interactions between mothers and infants coded by masked observers	4 months postpartum	No
Secondary	Breastfeeding duration		4- and 12 months postpartum	No
Secondary	Positive parenting behaviors (Parent Child Observation Guide)	Videotaped interactions between mothers and infants coded by masked observers	12- and 24 months postpartum	No
Secondary	Use of labor anesthesia		Start of labor through childbirth	No
Secondary	Labour Agentry Scale	The Labour Agentry Scale is a self-report scale that assesses maternal feelings of efficacy during labor	1 day postpartum	No
Secondary	Adult Adolescent Parenting Inventory (AAPI)	The AAPI is a self report scale that measures appropriate parenting attitudes	4 months postpartum	No
Secondary	Maternal Self-Efficacy Scale	The Maternal Self-Efficacy Scale is a self report scale that measures parenting efficacy with regard to infant care.	4-, 12-, and 24 months postpartum	No
Secondary	Parenting Stress Index (PSI)	The PSI is a self report scale that measures parenting stress and parent perceptions of the difficulty of her child	4-, 12-, and 24 months postpartum	No
Secondary	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.	4-, 12-, and 24 months postpartum	No
Secondary	Timing of solid food introduction to infant		4- and 12 months postpartum	No
Secondary	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.	12- and 24 months postpartum	No
Secondary	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.	24 months postpartum	No