Doula Home Visiting Randomized Trial

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947244
• Other study ID #: D89MC23146
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: October 2019

Study information

• Verified date: November 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding
• Child Development
• Depression, Postpartum
• Parenting

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	Health Resources and Services Administration (HRSA), Illinois Department of Human Services

References & Publications (3)

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.

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. — View 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;:. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks postpartum
Primary	Breastfeeding initiation		3 weeks postpartum
Secondary	Breastfeeding duration		3 week, 3 month, and 13 months postpartum
Secondary	Maternal Antenatal Attachment Scale (MAAS)	The MAAS is a self-report scale that assesses a mother's emotional bond with her unborn infant.	37 weeks of pregnancy
Secondary	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.	37 weeks pregnancy, and 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Secondary	Labour Agentry Scale	The Labour Agentry Scale is a self-report questionnaire that measures maternal feelings of efficacy during labor.	3 weeks postpartum
Secondary	Use of labor analgesia		3 weeks postpartum
Secondary	Maternal Postnatal Attachment Scale (MPAS)	The MPAS is a self-report measure used to assess the quality of mother to infant attachment.	3 weeks postpartum
Secondary	Parenting Stress Inventory (PSI)	The PSI is a self report scale that assesses parenting stress and parent perceptions of the difficult of her child	3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Secondary	Timing of solid food introduction		3 weeks, 3 months, and 13 months postpartum
Secondary	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.	3 months,13 months, and 30 months postpartum
Secondary	Infant/child ER visits	Mother report of number of infant/child emergency room visits and reasons for visits	3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Secondary	Infant/child immunizations	Mother report of whether child is up to date on immunizations	13 months, 30 months, and 4 years postpartum
Secondary	Infant/child hospitalizations	Mother report of number of infant/child hospitalizations and reasons for hospitalizations	3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Secondary	Adult Adolescent Parenting Inventory (AAPI)	The AAPI is a self report scale that measures appropriate parenting attitudes.	3 months, 13 months, 30 months, and 4 years postpartum
Secondary	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.	13 months postpartum
Secondary	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.	13 months and 30 months postpartum
Secondary	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.	13 months and 30 months postpartum
Secondary	Subsequent pregnancy	Mothers report on whether they are currently pregnant	3 month,13 months, 30 months, and 4 years postpartum
Secondary	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.	13 months, 30 months, and 4 years postpartum
Secondary	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.	3 months, 13 months, and 30 months postpartum
Secondary	Woodcock-Johnson III Tests of Achievement	The WJ-III measures child achievement in reading readiness and quantitative skills	4 years postpartum