Doula Home Visiting Randomized Trial

Study Overview
=================
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.

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

Conditions
-----------------
Breast Feeding, Parenting, Child Development, Depression, Postpartum

Intervention / Treatment
-----------------
* Behavioral: Doula Home Visiting
* Behavioral: Case management


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doula Home Visiting<br>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. | Behavioral: Doula Home Visiting<br>* 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.<br>|
| Active Comparator: Case Management<br>Mothers in the comparison group receive low intensity case management services during pregnancy and following the birth. | Behavioral: Case management<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 weeks postpartum | 
| Breastfeeding initiation |  | 3 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding duration |  | 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. | 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. | 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. | 3 weeks postpartum | 
| Use of labor analgesia |  | 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. | 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 | 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum | 
| Timing of solid food introduction |  | 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. | 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 | 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 | 13 months, 30 months, and 4 years postpartum | 
| Infant/child hospitalizations | Mother report of number of infant/child hospitalizations and reasons for hospitalizations | 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. | 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. | 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. | 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. | 13 months and 30 months postpartum | 
| Subsequent pregnancy | Mothers report on whether they are currently pregnant | 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. | 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. | 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 | 4 years postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Doulas, Parenting, Breast Feeding, Pregnancy in Adolescence, Child Development