Doula Home Visiting Randomized Trial
Illinois Maternal, Infant, and Early Childhood Home Visiting (MIECHV): Doula Randomized Controlled Trial
1 other identifier
interventional
312
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2011
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 13, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedNovember 6, 2020
November 1, 2020
7.9 years
September 13, 2013
November 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Breastfeeding initiation
3 weeks postpartum
Secondary Outcomes (20)
Breastfeeding duration
3 week, 3 month, and 13 months postpartum
Maternal Antenatal Attachment Scale (MAAS)
37 weeks of pregnancy
Center for Epidemiologic Studies Depression Scale (CES-D)
37 weeks pregnancy, and 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Labour Agentry Scale
3 weeks postpartum
Use of labor analgesia
3 weeks postpartum
- +15 more secondary outcomes
Study Arms (2)
Doula Home Visiting
EXPERIMENTALParticipants 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.
Case Management
ACTIVE COMPARATORMothers in the comparison group receive low intensity case management services during pregnancy and following the birth.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Chicagolead
- Health Resources and Services Administration (HRSA)collaborator
- Illinois Department of Human Servicescollaborator
Related Publications (3)
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.
PMID: 29855838BACKGROUNDHans 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.
PMID: 30128724BACKGROUNDEdwards 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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sydney L Hans, PhD
The University of Chicago, School of Social Service Administration
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2013
First Posted
September 20, 2013
Study Start
November 1, 2011
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
November 6, 2020
Record last verified: 2020-11