Doula Home Visiting Randomized Trial

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
Illinois Department of Human Services
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01947244
First received: September 13, 2013
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Breast Feeding
Parenting
Child Development
Depression, Postpartum
Behavioral: Doula Home Visiting
Behavioral: Case management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Illinois Maternal, Infant, and Early Childhood Home Visiting (MIECHV): Doula Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • National Institute of Child Health and Human Development (NICHD) mother-child interaction measures [ Time Frame: 3 weeks postpartum ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breastfeeding duration [ Time Frame: 3 week, 3 month, and 13 months postpartum ] [ Designated as safety issue: No ]
  • Maternal Antenatal Attachment Scale (MAAS) [ Time Frame: 37 weeks of pregnancy ] [ Designated as safety issue: No ]
    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, and 13 months postpartum ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Maternal Postnatal Attachment Scale (MPAS) [ Time Frame: 3 weeks postpartum ] [ Designated as safety issue: No ]
    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, and 13 months postpartum ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Knowledge of Infant Development Inventory (KIDI) [ Time Frame: 3 months and 13 months postpartum ] [ Designated as safety issue: No ]
    The KIDI is a self report questionnaire that assesses parent knowledge of parenting practices, infant behavior, and child development.

  • Infant ER visits [ Time Frame: 3 weeks, 3 months, and 13 months postpartum ] [ Designated as safety issue: No ]
    Mother report of number of infant emergency room visits and reasons for visits

  • Infant immunizations [ Time Frame: 13 months postpartum ] [ Designated as safety issue: No ]
    Mother report of whether child is up to date on immunizations

  • Infant hospitalizations [ Time Frame: 3 weeks, 3 months, and 13 months postpartum ] [ Designated as safety issue: No ]
    Mother report of number of infant hospitalizations and reasons for hospitalizations

  • Adult Adolescent Parenting Inventory (AAPI) [ Time Frame: 3 months and 13 months postpartum ] [ Designated as safety issue: No ]
    The AAPI is a self report scale that measures appropriate parenting attitudes.

  • Preschool Language Scales-5 (PLS-5) [ Time Frame: 13 months postpartum ] [ Designated as safety issue: No ]
    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 postpartum ] [ Designated as safety issue: No ]
    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 postpartum ] [ Designated as safety issue: No ]
    The ITSEA is a parent report scale that assesses problem behaviors and social competence of infants and toddlers.

  • Subsequent pregnancy [ Time Frame: 3 month and 13 months postpartum ] [ Designated as safety issue: No ]
    Mothers report on whether they are currently pregnant

  • Parent-Child Conflict Tactics Scales (CTS PC) [ Time Frame: 13 months postpartum ] [ Designated as safety issue: No ]
    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- and 13 months postpartum ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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-, and 13 months 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 followup, 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.

  Eligibility

Ages Eligible for Study:   14 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947244

Sponsors and Collaborators
University of Chicago
Health Resources and Services Administration (HRSA)
Illinois Department of Human Services
Investigators
Principal Investigator: Sydney L Hans, PhD The University of Chicago, School of Social Service Administration
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01947244     History of Changes
Other Study ID Numbers: D89MC23146
Study First Received: September 13, 2013
Last Updated: September 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Doulas
Parenting
Breast Feeding
Pregnancy in Adolescence
Child Development

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on July 23, 2014