Breast FeedingNCT01947244
Doula Home Visiting Randomized Trial
A study testing Doula Home Visiting and Case management in people with Breast Feeding and Parenting, run by University of Chicago.
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. Read more about this study
- Who is it for?
- Ages 14 to 24 years, women only
- Conditions the study is for
- Breast Feeding, Parenting, Child Development
- What is being tested?
- Doula Home Visiting and Case management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Illinois Maternal, Infant, and Early Childhood Home Visiting (MIECHV): Doula Randomized Controlled 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.
Read the 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.
- Conditions
- Breast Feeding, Parenting, Child Development, Depression, Postpartum
- Being tested
- Doula Home Visiting, Case management
- Keywords
- Doulas, Parenting, Breast Feeding, Pregnancy in Adolescence, Child Development
- Medical subject headings
- Breast Feeding, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doula Home VisitingBehavioural
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 managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Doula Home Visiting | Experimental | 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. Receives: Behavioral: Doula Home Visiting |
| Case Management | Active comparator | Mothers in the comparison group receive low intensity case management services during pregnancy and following the birth. Receives: Behavioral: Case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks postpartum
Breastfeeding initiation
Measured: 3 weeks postpartum
Secondary outcomes (20)
Breastfeeding duration
Measured: 3 week, 3 month, and 13 months postpartum
Maternal Antenatal Attachment Scale (MAAS)
The MAAS is a self-report scale that assesses a mother's emotional bond with her unborn infant.
Measured: 37 weeks of pregnancy
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.
Measured: 37 weeks pregnancy, and 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Labour Agentry Scale
The Labour Agentry Scale is a self-report questionnaire that measures maternal feelings of efficacy during labor.
Measured: 3 weeks postpartum
Use of labor analgesia
Measured: 3 weeks postpartum
Maternal Postnatal Attachment Scale (MPAS)
The MPAS is a self-report measure used to assess the quality of mother to infant attachment.
Measured: 3 weeks postpartum
Parenting Stress Inventory (PSI)
The PSI is a self report scale that assesses parenting stress and parent perceptions of the difficult of her child
Measured: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Timing of solid food introduction
Measured: 3 weeks, 3 months, and 13 months postpartum
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.
Measured: 3 months,13 months, and 30 months postpartum
Infant/child ER visits
Mother report of number of infant/child emergency room visits and reasons for visits
Measured: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Infant/child immunizations
Mother report of whether child is up to date on immunizations
Measured: 13 months, 30 months, and 4 years postpartum
Infant/child hospitalizations
Mother report of number of infant/child hospitalizations and reasons for hospitalizations
Measured: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Adult Adolescent Parenting Inventory (AAPI)
The AAPI is a self report scale that measures appropriate parenting attitudes.
Measured: 3 months, 13 months, 30 months, and 4 years postpartum
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.
Measured: 13 months postpartum
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.
Measured: 13 months and 30 months postpartum
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.
Measured: 13 months and 30 months postpartum
Subsequent pregnancy
Mothers report on whether they are currently pregnant
Measured: 3 month,13 months, 30 months, and 4 years postpartum
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.
Measured: 13 months, 30 months, and 4 years postpartum
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.
Measured: 3 months, 13 months, and 30 months postpartum
Woodcock-Johnson III Tests of Achievement
The WJ-III measures child achievement in reading readiness and quantitative skills
Measured: 4 years postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startNov 2011
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Illinois Department of Human Services
- Responsible party
- Sponsor
- Investigators
- Sydney L Hans, PhD, Principal investigator, The University of Chicago, School of Social Service Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947244
- Sponsor's protocol ID
- D89MC23146
- Status last verified
- Nov 2020
- First submitted
- 13 Sep 2013
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29855838Hans 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.
PubMed 30128724Edwards 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.
Edwards RC, Hans SL. Young mother risk-taking moderates doula home visiting impacts on parenting and toddler social-emotional development. Dev Psychopathol. 2024 Feb;36(1):236-254. doi: 10.1017/S0954579422001158. Epub 2022 Dec 16.
PubMed 36524235
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Illinois Maternal, Infant, and Early Childhood Home Visiting (MIECHV): Doula Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01947244
- Acronym / sponsor ID
- D89MC23146
- Conditions
- Breast Feeding, Parenting, Child Development, Depression, Postpartum
- Keywords
- Doulas, Parenting, Breast Feeding, Pregnancy in Adolescence, Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Illinois Department of Human Services
- Study start
- Nov 2011
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doula Home Visiting | Experimental | Behavioral: Doula Home VisitingParticipants 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 comparator | Behavioral: Case managementMothers in the comparison group receive low intensity case management services during pregnancy and following the birth. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doula Home VisitingThe 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. | Behavioural | Doula Home Visiting |
| Case managementMothers 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. | Behavioural | Case Management |
Primary outcome
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.
Breastfeeding initiation
Time frame: 3 weeks postpartum
20 secondary outcomes
Breastfeeding duration
Time frame: 3 week, 3 month, and 13 months postpartum
Maternal Antenatal Attachment Scale (MAAS)
Time frame: 37 weeks of pregnancy
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
Labour Agentry Scale
Time frame: 3 weeks postpartum
Use of labor analgesia
Time frame: 3 weeks postpartum
Maternal Postnatal Attachment Scale (MPAS)
Time frame: 3 weeks postpartum
Parenting Stress Inventory (PSI)
Time frame: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Timing of solid food introduction
Time frame: 3 weeks, 3 months, and 13 months postpartum
Knowledge of Infant Development Inventory (KIDI)
Time frame: 3 months,13 months, and 30 months postpartum
Infant/child ER visits
Time frame: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Infant/child immunizations
Time frame: 13 months, 30 months, and 4 years postpartum
Infant/child hospitalizations
Time frame: 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum
Adult Adolescent Parenting Inventory (AAPI)
Time frame: 3 months, 13 months, 30 months, and 4 years postpartum
Preschool Language Scales-5 (PLS-5)
Time frame: 13 months postpartum
Mullen Scales of Early Learning - Visual Reception
Time frame: 13 months and 30 months postpartum
Infant Toddler Social and Emotional Assessment (ITSEA)
Time frame: 13 months and 30 months postpartum
Subsequent pregnancy
Time frame: 3 month,13 months, 30 months, and 4 years postpartum
Parent-Child Conflict Tactics Scales (CTS PC)
Time frame: 13 months, 30 months, and 4 years postpartum
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures.
Time frame: 3 months, 13 months, and 30 months postpartum
Woodcock-Johnson III Tests of Achievement
Time frame: 4 years postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Background: PubMed 29855838Hans 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.
- Background: PubMed 30128724Hans 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.
- BackgroundEdwards 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.
- Derived from this study: PubMed 36524235Edwards RC, Hans SL. Young mother risk-taking moderates doula home visiting impacts on parenting and toddler social-emotional development. Dev Psychopathol. 2024 Feb;36(1):236-254. doi: 10.1017/S0954579422001158. Epub 2022 Dec 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sydney L Hans, PhD principal investigator
The University of Chicago, School of Social Service Administration
Questions about this trial
What is this clinical trial studying?
A study testing Doula Home Visiting and Case management in people with Breast Feeding and Parenting, run by University of Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures (time frame: 3 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947244, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.