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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
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

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

14 Years - 24 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

    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
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    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

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    Doula Home Visiting Randomized Trial

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