Clinical trial NCT01947244: Doula Home Visiting Randomized Trial
Official title: Illinois Maternal, Infant, and Early Childhood Home Visiting (MIECHV): Doula Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Parenting
Child Development
Depression, Postpartum
Keywords: Doulas
Parenting
Breast Feeding
Pregnancy in Adolescence
Child Development
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: Illinois Department of Human Services
First posted: 2013-09-20
Enrollment: 312
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: National Institute of Child Health and Human Development (NICHD) mother-child interaction measures
timeFrame: 3 weeks postpartum
measure: Breastfeeding initiation
timeFrame: 3 weeks postpartum
Secondary outcomes:
measure: Breastfeeding duration
timeFrame: 3 week, 3 month, and 13 months postpartum
measure: Maternal Antenatal Attachment Scale (MAAS)
timeFrame: 37 weeks of pregnancy
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 37 weeks pregnancy, and 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
measure: Labour Agentry Scale
timeFrame: 3 weeks postpartum
measure: Use of labor analgesia
timeFrame: 3 weeks postpartum
measure: Maternal Postnatal Attachment Scale (MPAS)
timeFrame: 3 weeks postpartum
measure: Parenting Stress Inventory (PSI)
timeFrame: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
measure: Timing of solid food introduction
timeFrame: 3 weeks, 3 months, and 13 months postpartum
measure: Knowledge of Infant Development Inventory (KIDI)
timeFrame: 3 months,13 months, and 30 months postpartum
measure: Infant/child ER visits
timeFrame: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
measure: Infant/child immunizations
timeFrame: 13 months, 30 months, and 4 years postpartum
measure: Infant/child hospitalizations
timeFrame: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
measure: Adult Adolescent Parenting Inventory (AAPI)
timeFrame: 3 months, 13 months, 30 months, and 4 years postpartum
measure: Preschool Language Scales-5 (PLS-5)
timeFrame: 13 months postpartum
measure: Mullen Scales of Early Learning - Visual Reception
timeFrame: 13 months and 30 months postpartum
measure: Infant Toddler Social and Emotional Assessment (ITSEA)
timeFrame: 13 months and 30 months postpartum
measure: Subsequent pregnancy
timeFrame: 3 month,13 months, 30 months, and 4 years postpartum
measure: Parent-Child Conflict Tactics Scales (CTS PC)
timeFrame: 13 months, 30 months, and 4 years postpartum
measure: National Institute of Child Health and Human Development (NICHD) mother-child interaction measures.
timeFrame: 3 months, 13 months, and 30 months postpartum
measure: Woodcock-Johnson III Tests of Achievement
timeFrame: 4 years postpartum
Other outcomes:
Locations:
Study officials:
affiliation: The University of Chicago, School of Social Service Administration
name: Sydney L Hans, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hans SL, Edwards RC, Zhang Y. Randomized Controlled Trial of Doula-Home-Visiting Services: Impact on Maternal and Infant Health. Matern Child Health J. 2018 Oct;22(Suppl 1):105-113. doi: 10.1007/s10995-018-2537-7.
citation: Hans SL, Edwards RC, Zhang Y. Correction to: Randomized Controlled Trial of Doula-Home-Visiting Services: Impact on Maternal and Infant Health. Matern Child Health J. 2018 Oct;22(Suppl 1):125. doi: 10.1007/s10995-018-2626-7.
citation: Edwards RC, Vieyra Y, Hans SL. Maternal support for infant learning: Findings from a randomized controlled trial of doula home visiting services for young mothers. Early Childhood Research Quarterly. 2020; 51: 26-38.