Doula Home Visiting Randomized Trial
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|ClinicalTrials.gov Identifier: NCT01947244|
Recruitment Status : Active, not recruiting
First Posted : September 20, 2013
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Feeding Parenting Child Development Depression, Postpartum||Behavioral: Doula Home Visiting Behavioral: Case management||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Illinois Maternal, Infant, and Early Childhood Home Visiting (MIECHV): Doula Randomized Controlled Trial|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: 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.
Behavioral: Doula 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.
Active Comparator: Case Management
Mothers in the comparison group receive low intensity case management services during pregnancy and following the birth.
Behavioral: Case 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.
- National Institute of Child Health and Human Development (NICHD) mother-child interaction measures [ Time Frame: 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 [ Time Frame: 3 weeks postpartum ]
- Breastfeeding duration [ Time Frame: 3 week, 3 month, and 13 months postpartum ]
- Maternal Antenatal Attachment Scale (MAAS) [ Time Frame: 37 weeks of pregnancy ]The MAAS is a self-report scale that assesses a mother's emotional bond with her unborn infant.
- Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 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.
- Labour Agentry Scale [ Time Frame: 3 weeks postpartum ]The Labour Agentry Scale is a self-report questionnaire that measures maternal feelings of efficacy during labor.
- Use of labor analgesia [ Time Frame: 3 weeks postpartum ]
- Maternal Postnatal Attachment Scale (MPAS) [ Time Frame: 3 weeks postpartum ]The MPAS is a self-report measure used to assess the quality of mother to infant attachment.
- Parenting Stress Inventory (PSI) [ Time Frame: 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 [ Time Frame: 3 weeks, 3 months, and 13 months postpartum ]
- Knowledge of Infant Development Inventory (KIDI) [ Time Frame: 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/child ER visits [ Time Frame: 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 [ Time Frame: 13 months, 30 months, and 4 years postpartum ]Mother report of whether child is up to date on immunizations
- Infant/child hospitalizations [ Time Frame: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum ]Mother report of number of infant/child hospitalizations and reasons for hospitalizations
- Adult Adolescent Parenting Inventory (AAPI) [ Time Frame: 3 months, 13 months, 30 months, and 4 years postpartum ]The AAPI is a self report scale that measures appropriate parenting attitudes.
- Preschool Language Scales-5 (PLS-5) [ Time Frame: 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.
- Mullen Scales of Early Learning - Visual Reception [ Time Frame: 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.
- Infant Toddler Social and Emotional Assessment (ITSEA) [ Time Frame: 13 months and 30 months postpartum ]The ITSEA is a parent report scale that assesses problem behaviors and social competence of infants and toddlers.
- Subsequent pregnancy [ Time Frame: 3 month,13 months, 30 months, and 4 years postpartum ]Mothers report on whether they are currently pregnant
- Parent-Child Conflict Tactics Scales (CTS PC) [ Time Frame: 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.
- National Institute of Child Health and Human Development (NICHD) mother-child interaction measures. [ Time Frame: 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.
- Woodcock-Johnson III Tests of Achievement [ Time Frame: 4 years postpartum ]The WJ-III measures child achievement in reading readiness and quantitative skills
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947244
|Principal Investigator:||Sydney L Hans, PhD||The University of Chicago, School of Social Service Administration|