Doula Home Visiting Randomized Trial
Primary Purpose
Breast Feeding, Parenting, Child Development
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Doula Home Visiting
Case management
Sponsored by
About this trial
This is an interventional prevention trial for Breast Feeding focused on measuring Doulas, Parenting, Breast Feeding, Pregnancy in Adolescence, Child Development
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Doula Home Visiting
Case Management
Arm Description
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.
Mothers in the comparison group receive low intensity case management services during pregnancy and following the birth.
Outcomes
Primary Outcome Measures
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.
Breastfeeding initiation
Secondary Outcome Measures
Breastfeeding duration
Maternal Antenatal Attachment Scale (MAAS)
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)
The CES-D is a self report scale that measures symptoms of depression experienced in the past week.
Labour Agentry Scale
The Labour Agentry Scale is a self-report questionnaire that measures maternal feelings of efficacy during labor.
Use of labor analgesia
Maternal Postnatal Attachment Scale (MPAS)
The MPAS is a self-report measure used to assess the quality of mother to infant attachment.
Parenting Stress Inventory (PSI)
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
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.
Infant/child ER visits
Mother report of number of infant/child emergency room visits and reasons for visits
Infant/child immunizations
Mother report of whether child is up to date on immunizations
Infant/child hospitalizations
Mother report of number of infant/child hospitalizations and reasons for hospitalizations
Adult Adolescent Parenting Inventory (AAPI)
The AAPI is a self report scale that measures appropriate parenting attitudes.
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.
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.
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.
Subsequent pregnancy
Mothers report on whether they are currently pregnant
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.
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.
Woodcock-Johnson III Tests of Achievement
The WJ-III measures child achievement in reading readiness and quantitative skills
Full Information
NCT ID
NCT01947244
First Posted
September 13, 2013
Last Updated
November 4, 2020
Sponsor
University of Chicago
Collaborators
Health Resources and Services Administration (HRSA), Illinois Department of Human Services
1. Study Identification
Unique Protocol Identification Number
NCT01947244
Brief Title
Doula Home Visiting Randomized Trial
Official Title
Illinois Maternal, Infant, and Early Childhood Home Visiting (MIECHV): Doula Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Health Resources and Services Administration (HRSA), Illinois Department of Human Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Feeding, Parenting, Child Development, Depression, Postpartum
Keywords
Doulas, Parenting, Breast Feeding, Pregnancy in Adolescence, Child Development
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
312 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doula Home Visiting
Arm Type
Experimental
Arm Description
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.
Arm Title
Case Management
Arm Type
Active Comparator
Arm Description
Mothers in the comparison group receive low intensity case management services during pregnancy and following the birth.
Intervention Type
Behavioral
Intervention Name(s)
Doula Home Visiting
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Case management
Intervention Description
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.
Primary Outcome Measure Information:
Title
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures
Description
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
Title
Breastfeeding initiation
Time Frame
3 weeks postpartum
Secondary Outcome Measure Information:
Title
Breastfeeding duration
Time Frame
3 week, 3 month, and 13 months postpartum
Title
Maternal Antenatal Attachment Scale (MAAS)
Description
The MAAS is a self-report scale that assesses a mother's emotional bond with her unborn infant.
Time Frame
37 weeks of pregnancy
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
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
Title
Labour Agentry Scale
Description
The Labour Agentry Scale is a self-report questionnaire that measures maternal feelings of efficacy during labor.
Time Frame
3 weeks postpartum
Title
Use of labor analgesia
Time Frame
3 weeks postpartum
Title
Maternal Postnatal Attachment Scale (MPAS)
Description
The MPAS is a self-report measure used to assess the quality of mother to infant attachment.
Time Frame
3 weeks postpartum
Title
Parenting Stress Inventory (PSI)
Description
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
Title
Timing of solid food introduction
Time Frame
3 weeks, 3 months, and 13 months postpartum
Title
Knowledge of Infant Development Inventory (KIDI)
Description
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
Title
Infant/child ER visits
Description
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
Title
Infant/child immunizations
Description
Mother report of whether child is up to date on immunizations
Time Frame
13 months, 30 months, and 4 years postpartum
Title
Infant/child hospitalizations
Description
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
Title
Adult Adolescent Parenting Inventory (AAPI)
Description
The AAPI is a self report scale that measures appropriate parenting attitudes.
Time Frame
3 months, 13 months, 30 months, and 4 years postpartum
Title
Preschool Language Scales-5 (PLS-5)
Description
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
Title
Mullen Scales of Early Learning - Visual Reception
Description
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
Title
Infant Toddler Social and Emotional Assessment (ITSEA)
Description
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
Title
Subsequent pregnancy
Description
Mothers report on whether they are currently pregnant
Time Frame
3 month,13 months, 30 months, and 4 years postpartum
Title
Parent-Child Conflict Tactics Scales (CTS PC)
Description
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
Title
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures.
Description
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
Title
Woodcock-Johnson III Tests of Achievement
Description
The WJ-III measures child achievement in reading readiness and quantitative skills
Time Frame
4 years postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sydney L Hans, PhD
Organizational Affiliation
The University of Chicago, School of Social Service Administration
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
29855838
Citation
Hans SL, Edwards RC, Zhang Y. Randomized Controlled Trial of Doula-Home-Visiting Services: Impact on Maternal and Infant Health. Matern Child Health J. 2018 Oct;22(Suppl 1):105-113. doi: 10.1007/s10995-018-2537-7. Erratum In: Matern Child Health J. 2018 Aug 20;:
Results Reference
background
PubMed Identifier
30128724
Citation
Hans SL, Edwards RC, Zhang Y. Correction to: Randomized Controlled Trial of Doula-Home-Visiting Services: Impact on Maternal and Infant Health. Matern Child Health J. 2018 Oct;22(Suppl 1):125. doi: 10.1007/s10995-018-2626-7.
Results Reference
background
Citation
Edwards RC, Vieyra Y, Hans SL. Maternal support for infant learning: Findings from a randomized controlled trial of doula home visiting services for young mothers. Early Childhood Research Quarterly. 2020; 51: 26-38.
Results Reference
background
Learn more about this trial
Doula Home Visiting Randomized Trial
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