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Doula Home Visiting Randomized Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01947244
Enrollment
312
Registered
2013-09-20
Start date
2011-11-30
Completion date
2019-10-31
Last updated
2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding, Child Development, Depression, Postpartum, Parenting

Keywords

Doulas, Parenting, Breast Feeding, Pregnancy in Adolescence, Child Development

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.

Interventions

BEHAVIORALDoula 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.

BEHAVIORALCase 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.

Sponsors

Health Resources and Services Administration (HRSA)
CollaboratorFED
Illinois Department of Human Services
CollaboratorUNKNOWN
University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 24 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures3 weeks postpartumVideotaped 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.
Breastfeeding initiation3 weeks postpartum

Secondary

MeasureTime frameDescription
Center for Epidemiologic Studies Depression Scale (CES-D)37 weeks pregnancy, and 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartumThe CES-D is a self report scale that measures symptoms of depression experienced in the past week.
Labour Agentry Scale3 weeks postpartumThe Labour Agentry Scale is a self-report questionnaire that measures maternal feelings of efficacy during labor.
Use of labor analgesia3 weeks postpartum
Maternal Postnatal Attachment Scale (MPAS)3 weeks postpartumThe MPAS is a self-report measure used to assess the quality of mother to infant attachment.
Parenting Stress Inventory (PSI)3 weeks, 3 months, 13 months, 30 months, and 4 years postpartumThe PSI is a self report scale that assesses parenting stress and parent perceptions of the difficult of her child
Timing of solid food introduction3 weeks, 3 months, and 13 months postpartum
Knowledge of Infant Development Inventory (KIDI)3 months,13 months, and 30 months postpartumThe KIDI is a self report questionnaire that assesses parent knowledge of parenting practices, infant behavior, and child development.
Infant/child ER visits3 weeks, 3 months, 13 months, 30 months, and 4 years postpartumMother report of number of infant/child emergency room visits and reasons for visits
Infant/child immunizations13 months, 30 months, and 4 years postpartumMother report of whether child is up to date on immunizations
Breastfeeding duration3 week, 3 month, and 13 months postpartum
Adult Adolescent Parenting Inventory (AAPI)3 months, 13 months, 30 months, and 4 years postpartumThe AAPI is a self report scale that measures appropriate parenting attitudes.
Preschool Language Scales-5 (PLS-5)13 months postpartumThe 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.
Mullen Scales of Early Learning - Visual Reception13 months and 30 months postpartumThe 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.
Infant Toddler Social and Emotional Assessment (ITSEA)13 months and 30 months postpartumThe ITSEA is a parent report scale that assesses problem behaviors and social competence of infants and toddlers.
Subsequent pregnancy3 month,13 months, 30 months, and 4 years postpartumMothers report on whether they are currently pregnant
Parent-Child Conflict Tactics Scales (CTS PC)13 months, 30 months, and 4 years postpartumThe CTS-PC is a parent report scale that measures how often parents use various forms of discipline and punishment with their children.
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures.3 months, 13 months, and 30 months postpartumVideotaped 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.
Woodcock-Johnson III Tests of Achievement4 years postpartumThe WJ-III measures child achievement in reading readiness and quantitative skills
Infant/child hospitalizations3 weeks, 3 months, 13 months, 30 months, and 4 years postpartumMother report of number of infant/child hospitalizations and reasons for hospitalizations
Maternal Antenatal Attachment Scale (MAAS)37 weeks of pregnancyThe MAAS is a self-report scale that assesses a mother's emotional bond with her unborn infant.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026