Overview

This trial is active, not recruiting.

Conditions breast feeding, parenting, child development, depression, postpartum
Treatments doula home visiting, case management
Sponsor University of Chicago
Collaborator Health Resources and Services Administration (HRSA)
Start date November 2011
End date September 2017
Trial size 300 participants
Trial identifier NCT01947244, D89MC23146

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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.
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)
Mothers in the comparison group receive low intensity case management services during pregnancy and following the birth.
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.

Primary Outcomes

Measure
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures
time frame: 3 weeks postpartum
Breastfeeding initiation
time frame: 3 weeks postpartum

Secondary Outcomes

Measure
Breastfeeding duration
time frame: 3 week, 3 month, and 13 months postpartum
Maternal Antenatal Attachment Scale (MAAS)
time frame: 37 weeks of pregnancy
Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: 37 weeks pregnancy, and 3 weeks, 3 months, 13 months, and 30 months postpartum
Labour Agentry Scale
time frame: 3 weeks postpartum
Use of labor analgesia
time frame: 3 weeks postpartum
Maternal Postnatal Attachment Scale (MPAS)
time frame: 3 weeks postpartum
Parenting Stress Inventory (PSI)
time frame: 3 weeks, 3 months, 13 months, and 30 months postpartum
Timing of solid food introduction
time frame: 3 weeks, 3 months, and 13 months postpartum
Knowledge of Infant Development Inventory (KIDI)
time frame: 3 months and 13 months postpartum
Infant ER visits
time frame: 3 weeks, 3 months, 13 months and 30 months postpartum
Infant immunizations
time frame: 13 months and 30 months postpartum
Infant hospitalizations
time frame: 3 weeks, 3 months, 13 months, and 30 months postpartum
Adult Adolescent Parenting Inventory (AAPI)
time frame: 3 months, 13 months, and 30 months postpartum
Preschool Language Scales-5 (PLS-5)
time frame: 13 months postpartum
Mullen Scales of Early Learning - Visual Reception
time frame: 13 months and 30 months postpartum
Infant Toddler Social and Emotional Assessment (ITSEA)
time frame: 13 months and 30 months postpartum
Subsequent pregnancy
time frame: 3 month,13 months, and 30 months postpartum
Parent-Child Conflict Tactics Scales (CTS PC)
time frame: 13 months and 30 months postpartum
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures.
time frame: 3 months, 13 months, and 30 months postpartum

Eligibility Criteria

Female participants from 14 years up to 24 years old.

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

Additional Information

Official title Illinois Maternal, Infant, and Early Childhood Home Visiting (MIECHV): Doula Randomized Controlled Trial
Principal investigator Sydney L Hans, PhD
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 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 and 30 month 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Chicago.