Doula Home Visiting Randomized Trial
- Conditions
- Breast FeedingChild DevelopmentParentingDepression, Postpartum
- Interventions
- Behavioral: Doula Home VisitingBehavioral: Case management
- Registration Number
- NCT01947244
- Lead Sponsor
- University of Chicago
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 312
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Doula Home Visiting 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. Case Management Case management Mothers in the comparison group receive low intensity case management services during pregnancy and following the birth.
- Primary Outcome Measures
Name Time Method National Institute of Child Health and Human Development (NICHD) mother-child interaction measures 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.
Breastfeeding initiation 3 weeks postpartum
- Secondary Outcome Measures
Name Time Method Woodcock-Johnson III Tests of Achievement 4 years postpartum The WJ-III measures child achievement in reading readiness and quantitative skills
Breastfeeding duration 3 week, 3 month, and 13 months postpartum Center for Epidemiologic Studies Depression Scale (CES-D) 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.
Adult Adolescent Parenting Inventory (AAPI) 3 months, 13 months, 30 months, and 4 years postpartum The AAPI is a self report scale that measures appropriate parenting attitudes.
Mullen Scales of Early Learning - Visual Reception 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.
Subsequent pregnancy 3 month,13 months, 30 months, and 4 years postpartum Mothers report on whether they are currently pregnant
Parenting Stress Inventory (PSI) 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
Timing of solid food introduction 3 weeks, 3 months, and 13 months postpartum Knowledge of Infant Development Inventory (KIDI) 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.
Infant Toddler Social and Emotional Assessment (ITSEA) 13 months and 30 months postpartum The ITSEA is a parent report scale that assesses problem behaviors and social competence of infants and toddlers.
Labour Agentry Scale 3 weeks postpartum The Labour Agentry Scale is a self-report questionnaire that measures maternal feelings of efficacy during labor.
Use of labor analgesia 3 weeks postpartum Maternal Postnatal Attachment Scale (MPAS) 3 weeks postpartum The MPAS is a self-report measure used to assess the quality of mother to infant attachment.
Infant/child hospitalizations 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum Mother report of number of infant/child hospitalizations and reasons for hospitalizations
Parent-Child Conflict Tactics Scales (CTS PC) 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.
Maternal Antenatal Attachment Scale (MAAS) 37 weeks of pregnancy The MAAS is a self-report scale that assesses a mother's emotional bond with her unborn infant.
Infant/child ER visits 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
Infant/child immunizations 13 months, 30 months, and 4 years postpartum Mother report of whether child is up to date on immunizations
Preschool Language Scales-5 (PLS-5) 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.
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures. 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.