ParentingNCT01925664
Doula Support for Young Mothers: A Randomized Trial
A study testing Doula in people with Parenting and Breastfeeding, run by University of Chicago at 1 site in United States.
Trial summary
The goal of this study was to evaluate the impact of a doula home visiting intervention on young, low-income mothers' birth outcomes, breastfeeding, postpartum depressive symptoms, and parenting, and on their children's development. Read more about this study
- Who is it for?
- Ages 14 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parenting, Breastfeeding, Depression, Postpartum
- What is being tested?
- Doula
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Aug 2006
- 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 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- pregnant and less than 34 weeks gestation
- planning to deliver at study hospital
- between ages 14 and 21
Who cannot join
- planning to move out of community after giving birth
- planning to give up custody of infant
- prior c-section delivery
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study was to evaluate the impact of a doula home visiting intervention on young, low-income mothers' birth outcomes, breastfeeding, postpartum depressive symptoms, and parenting, and on their children's development.
Read the detailed description
The goal of this study is to evaluate a doula home visiting model -- sometimes called the "community doula model." This model differs from typical hospital based doula interventions in several ways. Doulas are providers from the same community backgrounds as their clients. Services are not just provided during labor and delivery, but throughout the final trimester and during the first weeks after delivery. Prenatal and postpartum services are provided in the homes of the mothers. The model was developed specifically for working with low-income mothers and with young mothers.
A two-armed randomized controlled trial was conducted at the University of Chicago Hospitals. Participants were recruited through two out-patient obstetric clinics affiliated with the Hospitals. The clinics primarily served a low-income, African-American population, reflective of the families in the communities near to the hospital. The study was open to all young women receiving prenatal care at the clinics who met age and eligibility criteria. After providing informed consent and completing a baseline interview, participants were randomized into two groups. The experimental group, in addition to receiving regular clinical care, received weekly home visiting services from a doula and the support of a doula at the hospital during labor and delivery. Doulas worked with their clients until three months postpartum. The control group received standard clinical care and had access to social work case management.
Four paraprofessional doulas delivered the study intervention. Before providing study services, doulas had been trained to provide childbirth education, labor support, breastfeeding education, and parent-child interaction support.
Followup research assessments of the doula and control group mothers and infants were conducted during the first three days postpartum, at 4 months postpartum, at 12 months postpartum, and at 24 months postpartum. 80% of the sample was retained through the 24 month followup assessment. Follow up assessments involved interviews with the mothers, videotaping of mother-infant interaction, and behavioral assessment of the infants. Obstetric and newborn hospital medical charts were also reviewed.
The study evaluated outcomes that have been the focus of prior studies of hospital-only doula services: use of obstetrical intervention in labor and delivery (anesthesia, surgical delivery), mother labor efficacy, breastfeeding, and maternal depression. A major contribution of this study is to explore longer term outcomes not evaluated in prior studies of doula intervention, particularly parenting and child development outcomes. The study evaluated multiple dimensions of parenting including parenting behavior (sensitivity, stimulation), parenting efficacy, parenting attitudes, and parenting stress. Child development outcomes included cognitive development and early behavior problems.
- Conditions
- Parenting, Breastfeeding, Depression, Postpartum
- Being tested
- Doula
- Keywords
- Doulas, Parenting, Breastfeeding, Pregnancy in Adolescence
- 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.
DoulaBehavioural
This intervention included doulas providing weekly home visits during the last trimester of pregnancy and up to three months postpartum. Home visits focused on prenatal health, preparation for childbirth, breastfeeding education, and developing a relationship with the baby. Doulas also were present in the hospital during labor, delivery, and postpartum providing emotional support, non-medical comfort measures, and breastfeeding counseling.
| Study group | Role | What they receive |
|---|---|---|
| Doula | Experimental | Mothers received doula home visiting services in addition to normal prenatal and obstetric clinical care and had access to social work case management. Receives: Behavioral: Doula |
| Usual Care | No intervention | Mothers received normal prenatal and obstetric clinical care and had access to social work case management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Initiation
Measured: Three days postpartum
Positive parenting behavior (Parent Child Observation Guide)
Videotaped interactions between mothers and infants coded by masked observers
Measured: 4 months postpartum
Secondary outcomes (11)
Breastfeeding duration
Measured: 4- and 12 months postpartum
Positive parenting behaviors (Parent Child Observation Guide)
Videotaped interactions between mothers and infants coded by masked observers
Measured: 12- and 24 months postpartum
Use of labor anesthesia
Measured: Start of labor through childbirth
Labour Agentry Scale
The Labour Agentry Scale is a self-report scale that assesses maternal feelings of efficacy during labor
Measured: 1 day postpartum
Adult Adolescent Parenting Inventory (AAPI)
The AAPI is a self report scale that measures appropriate parenting attitudes
Measured: 4 months postpartum
Maternal Self-Efficacy Scale
The Maternal Self-Efficacy Scale is a self report scale that measures parenting efficacy with regard to infant care.
Measured: 4-, 12-, and 24 months postpartum
Parenting Stress Index (PSI)
The PSI is a self report scale that measures parenting stress and parent perceptions of the difficulty of her child
Measured: 4-, 12-, and 24 months postpartum
Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D is a self report scale that measures depressive symptoms experienced in the prior week.
Measured: 4-, 12-, and 24 months postpartum
Timing of solid food introduction to infant
Measured: 4- and 12 months postpartum
The Brief Infant Toddler Social Emotional Assessment (BITSEA)
The BITSEA is a parent report measure that assesses problem behaviors and social competence in infants and toddlers.
Measured: 12- and 24 months postpartum
Mullen Scales of Early Learning
The Mullen is an assessment tool that measures child motor, cognitive, and language development. Trained assessors administered the instrument to the toddlers of study mothers.
Measured: 24 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJan 2001
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies 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
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Responsible party
- Sponsor
- Investigators
- Sydney L Hans, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925664
- Sponsor's protocol ID
- R40 MC 00203
- Status last verified
- Sep 2013
- First submitted
- 14 Aug 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Edwards RC, Thullen MJ, Korfmacher J, Lantos JD, Henson LG, Hans SL. Breastfeeding and complementary food: randomized trial of community doula home visiting. Pediatrics. 2013 Nov;132 Suppl 2:S160-6. doi: 10.1542/peds.2013-1021P.
PubMed 24187119
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doula Support for Young Mothers: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01925664
- Acronym / sponsor ID
- R40 MC 00203
- Conditions
- Parenting, Breastfeeding, Depression, Postpartum
- Keywords
- Doulas, Parenting, Breastfeeding, Pregnancy in Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- Jan 2001
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 20 Aug 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 goal of this study was to evaluate the impact of a doula home visiting intervention on young, low-income mothers' birth outcomes, breastfeeding, postpartum depressive symptoms, and parenting, and on their children's development.
Detailed description
The goal of this study is to evaluate a doula home visiting model -- sometimes called the "community doula model." This model differs from typical hospital based doula interventions in several ways. Doulas are providers from the same community backgrounds as their clients. Services are not just provided during labor and delivery, but throughout the final trimester and during the first weeks after delivery. Prenatal and postpartum services are provided in the homes of the mothers. The model was developed specifically for working with low-income mothers and with young mothers.
A two-armed randomized controlled trial was conducted at the University of Chicago Hospitals. Participants were recruited through two out-patient obstetric clinics affiliated with the Hospitals. The clinics primarily served a low-income, African-American population, reflective of the families in the communities near to the hospital. The study was open to all young women receiving prenatal care at the clinics who met age and eligibility criteria. After providing informed consent and completing a baseline interview, participants were randomized into two groups. The experimental group, in addition to receiving regular clinical care, received weekly home visiting services from a doula and the support of a doula at the hospital during labor and delivery. Doulas worked with their clients until three months postpartum. The control group received standard clinical care and had access to social work case management.
Four paraprofessional doulas delivered the study intervention. Before providing study services, doulas had been trained to provide childbirth education, labor support, breastfeeding education, and parent-child interaction support.
Followup research assessments of the doula and control group mothers and infants were conducted during the first three days postpartum, at 4 months postpartum, at 12 months postpartum, and at 24 months postpartum. 80% of the sample was retained through the 24 month followup assessment. Follow up assessments involved interviews with the mothers, videotaping of mother-infant interaction, and behavioral assessment of the infants. Obstetric and newborn hospital medical charts were also reviewed.
The study evaluated outcomes that have been the focus of prior studies of hospital-only doula services: use of obstetrical intervention in labor and delivery (anesthesia, surgical delivery), mother labor efficacy, breastfeeding, and maternal depression. A major contribution of this study is to explore longer term outcomes not evaluated in prior studies of doula intervention, particularly parenting and child development outcomes. The study evaluated multiple dimensions of parenting including parenting behavior (sensitivity, stimulation), parenting efficacy, parenting attitudes, and parenting stress. Child development outcomes included cognitive development and early behavior problems.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doula | Experimental | Behavioral: DoulaMothers received doula home visiting services in addition to normal prenatal and obstetric clinical care and had access to social work case management. |
| Usual Care | No intervention | –Mothers received normal prenatal and obstetric clinical care and had access to social work case management. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- pregnant and less than 34 weeks gestation
- planning to deliver at study hospital
- between ages 14 and 21
Key exclusion criteria (3 listed)
- planning to move out of community after giving birth
- planning to give up custody of infant
- prior c-section delivery
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 |
|---|---|---|
| DoulaThis intervention included doulas providing weekly home visits during the last trimester of pregnancy and up to three months postpartum. Home visits focused on prenatal health, preparation for childbirth, breastfeeding education, and developing a relationship with the baby. Doulas also were present in the hospital during labor, delivery, and postpartum providing emotional support, non-medical comfort measures, and breastfeeding counseling. | Behavioural | Doula |
Primary outcome
Breastfeeding Initiation
Time frame: Three days postpartum
Positive parenting behavior (Parent Child Observation Guide)
Time frame: 4 months postpartum
Videotaped interactions between mothers and infants coded by masked observers
11 secondary outcomes
Breastfeeding duration
Time frame: 4- and 12 months postpartum
Positive parenting behaviors (Parent Child Observation Guide)
Time frame: 12- and 24 months postpartum
Use of labor anesthesia
Time frame: Start of labor through childbirth
Labour Agentry Scale
Time frame: 1 day postpartum
Adult Adolescent Parenting Inventory (AAPI)
Time frame: 4 months postpartum
Maternal Self-Efficacy Scale
Time frame: 4-, 12-, and 24 months postpartum
Parenting Stress Index (PSI)
Time frame: 4-, 12-, and 24 months postpartum
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 4-, 12-, and 24 months postpartum
Timing of solid food introduction to infant
Time frame: 4- and 12 months postpartum
The Brief Infant Toddler Social Emotional Assessment (BITSEA)
Time frame: 12- and 24 months postpartum
Mullen Scales of Early Learning
Time frame: 24 months 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 5 Sep 2013.
- Derived from this study: PubMed 24187119Edwards RC, Thullen MJ, Korfmacher J, Lantos JD, Henson LG, Hans SL. Breastfeeding and complementary food: randomized trial of community doula home visiting. Pediatrics. 2013 Nov;132 Suppl 2:S160-6. doi: 10.1542/peds.2013-1021P.
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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
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doula in people with Parenting and Breastfeeding, run by University of Chicago at 1 site in United States.
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 3 inclusion and 3 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 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Breastfeeding Initiation (time frame: Three days 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 NCT01925664, which also lists 1 linked publication.
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 5 Sep 2013.