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Completed

NCT Number: NCT01947244

Doula Home Visiting Randomized Trial

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.

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Key information

Conditions

Breast Feeding Behavior Child Development Depression, Postpartum Depressive Disorder Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Parenting Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

14 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doula Home Visiting

Behavioral

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.

Case Management

Behavioral

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 outcomes

  1. 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.

  2. Breastfeeding initiation

    Time frame: 3 weeks postpartum

Secondary outcomes

  1. Breastfeeding duration

    Time frame: 3 week, 3 month, and 13 months postpartum

  2. 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.

  3. 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.

  4. 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.

  5. Use of labor analgesia

    Time frame: 3 weeks postpartum

  6. 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.

  7. 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

  8. Timing of solid food introduction

    Time frame: 3 weeks, 3 months, and 13 months postpartum

  9. 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.

  10. 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

  11. Infant/child immunizations

    Time frame: 13 months, 30 months, and 4 years postpartum

    Mother report of whether child is up to date on immunizations

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. Subsequent pregnancy

    Time frame: 3 month,13 months, 30 months, and 4 years postpartum

    Mothers report on whether they are currently pregnant

  18. 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.

  19. 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.

  20. Woodcock-Johnson III Tests of Achievement

    Time frame: 4 years postpartum

    The WJ-III measures child achievement in reading readiness and quantitative skills

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Health Resources and Services Administration (HRSA)
  • Illinois Department of Human Services

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2013
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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