Doula Home Visiting Randomized Trial

November 4, 2020 updated by: University of Chicago

Illinois Maternal, Infant, and Early Childhood Home Visiting (MIECHV): Doula Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Doula Home Visiting
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.
Behavioral: Doula Home Visiting
The intervention is a doula enhancement to evidence-based home visiting services. Doulas provide home visits during pregnancy and for the first six weeks postpartum, which focus on prenatal health, preparation for childbirth, bonding with the baby, and breastfeeding education. Family support workers provide longer term home visiting services. These home visits focus on sensitive and responsive parenting, early infant care, bonding with the baby, child health and development, and maternal mental health.
Active Comparator: Case Management
Mothers in the comparison group receive low intensity case management services during pregnancy and following the birth.
Behavioral: Case management
Mothers are offered two prenatal and two postpartum case management meetings to assess whether mothers' basic needs (housing, nutrition, health care, mental health) are being met and make appropriate referrals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures
Time Frame: 3 weeks postpartum
Videotaped interactions between mothers and infants coded by masked observers for maternal sensitivity, intrusiveness, detachment, stimulation of cognitive development, positive and negative regard for the child, and flatness of affect.
3 weeks postpartum
Breastfeeding initiation
Time Frame: 3 weeks postpartum
3 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding duration
Time Frame: 3 week, 3 month, and 13 months postpartum
3 week, 3 month, and 13 months postpartum
Maternal Antenatal Attachment Scale (MAAS)
Time Frame: 37 weeks of pregnancy
The MAAS is a self-report scale that assesses a mother's emotional bond with her unborn infant.
37 weeks of pregnancy
Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: 37 weeks pregnancy, and 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
The CES-D is a self report scale that measures symptoms of depression experienced in the past week.
37 weeks pregnancy, and 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Labour Agentry Scale
Time Frame: 3 weeks postpartum
The Labour Agentry Scale is a self-report questionnaire that measures maternal feelings of efficacy during labor.
3 weeks postpartum
Use of labor analgesia
Time Frame: 3 weeks postpartum
3 weeks postpartum
Maternal Postnatal Attachment Scale (MPAS)
Time Frame: 3 weeks postpartum
The MPAS is a self-report measure used to assess the quality of mother to infant attachment.
3 weeks postpartum
Parenting Stress Inventory (PSI)
Time Frame: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
The PSI is a self report scale that assesses parenting stress and parent perceptions of the difficult of her child
3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Timing of solid food introduction
Time Frame: 3 weeks, 3 months, and 13 months postpartum
3 weeks, 3 months, and 13 months postpartum
Knowledge of Infant Development Inventory (KIDI)
Time Frame: 3 months,13 months, and 30 months postpartum
The KIDI is a self report questionnaire that assesses parent knowledge of parenting practices, infant behavior, and child development.
3 months,13 months, and 30 months postpartum
Infant/child ER visits
Time Frame: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Mother report of number of infant/child emergency room visits and reasons for visits
3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Infant/child immunizations
Time Frame: 13 months, 30 months, and 4 years postpartum
Mother report of whether child is up to date on immunizations
13 months, 30 months, and 4 years postpartum
Infant/child hospitalizations
Time Frame: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Mother report of number of infant/child hospitalizations and reasons for hospitalizations
3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Adult Adolescent Parenting Inventory (AAPI)
Time Frame: 3 months, 13 months, 30 months, and 4 years postpartum
The AAPI is a self report scale that measures appropriate parenting attitudes.
3 months, 13 months, 30 months, and 4 years postpartum
Preschool Language Scales-5 (PLS-5)
Time Frame: 13 months postpartum
The PLS-5 is an interactive assessment that measures children's auditory comprehension and expressive language. Trained assessors blind to intervention status administer the test to children of study participants.
13 months postpartum
Mullen Scales of Early Learning - Visual Reception
Time Frame: 13 months and 30 months postpartum
The visual reception subscale of the Mullen measures children's ability to process information using patterns, sequencing, and memory. Trained assessors blind to intervention status administer the test to children of study participants.
13 months and 30 months postpartum
Infant Toddler Social and Emotional Assessment (ITSEA)
Time Frame: 13 months and 30 months postpartum
The ITSEA is a parent report scale that assesses problem behaviors and social competence of infants and toddlers.
13 months and 30 months postpartum
Subsequent pregnancy
Time Frame: 3 month,13 months, 30 months, and 4 years postpartum
Mothers report on whether they are currently pregnant
3 month,13 months, 30 months, and 4 years postpartum
Parent-Child Conflict Tactics Scales (CTS PC)
Time Frame: 13 months, 30 months, and 4 years postpartum
The CTS-PC is a parent report scale that measures how often parents use various forms of discipline and punishment with their children.
13 months, 30 months, and 4 years postpartum
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures.
Time Frame: 3 months, 13 months, and 30 months postpartum
Videotaped interactions between mothers and infants coded by masked observers for maternal sensitivity, intrusiveness, detachment, stimulation of cognitive development, positive and negative regard for the child, and flatness of affect.
3 months, 13 months, and 30 months postpartum
Woodcock-Johnson III Tests of Achievement
Time Frame: 4 years postpartum
The WJ-III measures child achievement in reading readiness and quantitative skills
4 years postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Health Resources and Services Administration (HRSA)
Illinois Department of Human Services

Investigators

  • Principal Investigator: Sydney L Hans, PhD, The University of Chicago, School of Social Service Administration

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

September 13, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D89MC23146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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