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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
312
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.
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.
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures
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.
Time frame: 3 weeks postpartum
Breastfeeding initiation
Time frame: 3 weeks postpartum
Breastfeeding duration
Time frame: 3 week, 3 month, and 13 months postpartum
Maternal Antenatal Attachment Scale (MAAS)
The MAAS is a self-report scale that assesses a mother's emotional bond with her unborn infant.
Time frame: 37 weeks of pregnancy
Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D is a self report scale that measures symptoms of depression experienced in the past week.
Time frame: 37 weeks pregnancy, and 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Labour Agentry Scale
The Labour Agentry Scale is a self-report questionnaire that measures maternal feelings of efficacy during labor.
Time frame: 3 weeks postpartum
Use of labor analgesia
Time frame: 3 weeks postpartum
Maternal Postnatal Attachment Scale (MPAS)
The MPAS is a self-report measure used to assess the quality of mother to infant attachment.
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Time frame: 3 weeks postpartum
Parenting Stress Inventory (PSI)
The PSI is a self report scale that assesses parenting stress and parent perceptions of the difficult of her child
Time frame: 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
Knowledge of Infant Development Inventory (KIDI)
The KIDI is a self report questionnaire that assesses parent knowledge of parenting practices, infant behavior, and child development.
Time frame: 3 months,13 months, and 30 months postpartum
Infant/child ER visits
Mother report of number of infant/child emergency room visits and reasons for visits
Time frame: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Infant/child immunizations
Mother report of whether child is up to date on immunizations
Time frame: 13 months, 30 months, and 4 years postpartum
Infant/child hospitalizations
Mother report of number of infant/child hospitalizations and reasons for hospitalizations
Time frame: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Adult Adolescent Parenting Inventory (AAPI)
The AAPI is a self report scale that measures appropriate parenting attitudes.
Time frame: 3 months, 13 months, 30 months, and 4 years postpartum
Preschool Language Scales-5 (PLS-5)
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.
Time frame: 13 months postpartum
Mullen Scales of Early Learning - Visual Reception
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.
Time frame: 13 months and 30 months postpartum
Infant Toddler Social and Emotional Assessment (ITSEA)
The ITSEA is a parent report scale that assesses problem behaviors and social competence of infants and toddlers.
Time frame: 13 months and 30 months postpartum
Subsequent pregnancy
Mothers report on whether they are currently pregnant
Time frame: 3 month,13 months, 30 months, and 4 years postpartum
Parent-Child Conflict Tactics Scales (CTS PC)
The CTS-PC is a parent report scale that measures how often parents use various forms of discipline and punishment with their children.
Time frame: 13 months, 30 months, and 4 years postpartum
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures.
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.
Time frame: 3 months, 13 months, and 30 months postpartum
Woodcock-Johnson III Tests of Achievement
The WJ-III measures child achievement in reading readiness and quantitative skills
Time frame: 4 years postpartum