Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Doula Support for Young Mothers: A Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01925664
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : September 5, 2013
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parenting Breastfeeding Depression, Postpartum Behavioral: Doula Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Doula Support for Young Mothers: A Randomized Trial
Study Start Date : January 2001
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Doula
Mothers received doula home visiting services in addition to normal prenatal and obstetric clinical care and had access to social work case management.
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.

No Intervention: Usual Care
Mothers received normal prenatal and obstetric clinical care and had access to social work case management.



Primary Outcome Measures :
  1. Breastfeeding Initiation [ Time Frame: Three days postpartum ]
  2. Positive parenting behavior (Parent Child Observation Guide) [ Time Frame: 4 months postpartum ]
    Videotaped interactions between mothers and infants coded by masked observers


Secondary Outcome Measures :
  1. Breastfeeding duration [ Time Frame: 4- and 12 months postpartum ]
  2. Positive parenting behaviors (Parent Child Observation Guide) [ Time Frame: 12- and 24 months postpartum ]
    Videotaped interactions between mothers and infants coded by masked observers

  3. Use of labor anesthesia [ Time Frame: Start of labor through childbirth ]
  4. Labour Agentry Scale [ Time Frame: 1 day postpartum ]
    The Labour Agentry Scale is a self-report scale that assesses maternal feelings of efficacy during labor

  5. Adult Adolescent Parenting Inventory (AAPI) [ Time Frame: 4 months postpartum ]
    The AAPI is a self report scale that measures appropriate parenting attitudes

  6. Maternal Self-Efficacy Scale [ Time Frame: 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.

  7. Parenting Stress Index (PSI) [ Time Frame: 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

  8. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 4-, 12-, and 24 months postpartum ]
    The CES-D is a self report scale that measures depressive symptoms experienced in the prior week.

  9. Timing of solid food introduction to infant [ Time Frame: 4- and 12 months postpartum ]
  10. The Brief Infant Toddler Social Emotional Assessment (BITSEA) [ Time Frame: 12- and 24 months postpartum ]
    The BITSEA is a parent report measure that assesses problem behaviors and social competence in infants and toddlers.

  11. Mullen Scales of Early Learning [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925664


Locations
Layout table for location information
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
HRSA/Maternal and Child Health Bureau
Investigators
Layout table for investigator information
Principal Investigator: Sydney L Hans, PhD University of Chicago
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01925664    
Other Study ID Numbers: R40 MC 00203
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013
Keywords provided by University of Chicago:
Doulas
Parenting
Breastfeeding
Pregnancy in Adolescence
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression, Postpartum
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders