Depression, PostpartumNCT02559986
Follow up of Mothers Suspected of Postpartum Depression
An observational study of Depression, Postpartum, run by Indiana University.
Trial summary
Postpartum depression (PD) is a serious and disabling mental health condition that affects 10-15% of women after childbirth. Low-income minority women are disproportionately affected. Untreated PD can lead to significant negative outcomes for both mother and child. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- telephone interview
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2014
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Mothers whose children received care at one of 4 community general pediatrics clinic with the Child Health Improvement through Computer Automation (CHICA) system who had a positive PD screen and brought the child to the majority of the child's visits to the study clinic
Who may be able to join
- -mothers with a positive PD screen who brought their child to seek medical care at participating study clinics, who were present for a majority of the child's visits.
Who cannot join
- -not biological mother, did not bring child to majority of clinic visits
About this study
Official title: Follow-up of Postpartum Depression After Referral From Pediatric Clinics
Postpartum depression (PD) is a serious and disabling mental health condition that affects 10-15% of women after childbirth. Low-income minority women are disproportionately affected. Untreated PD can lead to significant negative outcomes for both mother and child. Pediatricians are being asked to routinely screen for PD and while screening rates are improving, little is known about whether mothers actually adhere to pediatrician recommendations to seek additional help after a positive PD screen. The objective of this study is to describe the rate at which mothers seek treatment for suspected PD after a positive screen at the pediatrician office. Additional examination will look at factors that predict whether a mother recalls a recommendation to seek treatment.
Read the detailed description
The primary outcome of interest is whether mothers suspected of having PD seek treatment after discussion with the pediatrician. In order to evaluate whether discussion with pediatricians leads mothers to seek care, data collection efforts should focus on what information was exchanged, the level of shared decision-making about possible treatment options and whether an agreed upon plan was reached between both parties. The investigators will examine the effectiveness of these discussions by interviewing mothers who were suspected of having PD and referred for treatment. The investigators hypothesize that pediatricians who are able to engage mothers in a shared decision will result in more of those mothers seeking help and getting into appropriate treatment for PD.
The specific research aims of this proposal are to:
Aim 1: Describe the rate at which mothers suspected by pediatricians of having PD seek treatment.
Aim 2: Explore what factors predict whether mothers suspected of PD seek treatment, including maternal sociodemographic characteristics, family centeredness of pediatrician care, and extent of shared decision-making strategy used by the pediatrician.
This will be a cohort study examining the rate at which mothers suspected of having PD seek care and the relationship between shared decision-making and seeking mental health care. Data for both specific aims will be collected by a single telephone interview with mothers suspected of having PD by the pediatrician and referred. For this study, investigators will be focusing recruitment efforts in the four Wishard community health centers (now Eskenazi Health) that use CHICA. In 2007, these four clinics saw 8,528 patients between the ages of 0 and 3 years. These clinics serve a large proportion of families that are underserved, economically disadvantaged and are ethnically and racially diverse.
- Conditions
- Depression, Postpartum
- Being tested
- telephone interview
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone interviewOther
telephone interview about their care received during the first year of life and associated events
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate at which mothers sought treatment for suspected PD
Defined broadly as a positive response to either called adult care provider (primary care provider, obstetrician, or mental health therapist) for appointment or community resource
Measured: Within 1 year of index visit
Secondary outcomes (1)
Factors associated with help seeking behavior
socio-demographics and other characteristics
Measured: Within 1 year of index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nerissa Bauer, Indiana University
- Investigators
- Nerissa S Bauer, MD, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559986
- Sponsor's protocol ID
- 1111007501
- Status last verified
- Sep 2015
- First submitted
- 23 Sep 2015
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Postpartum Depression After Referral From Pediatric Clinics
- ClinicalTrials.gov ID
- NCT02559986
- Acronym / sponsor ID
- 1111007501
- Conditions
- Depression, Postpartum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Sep 2015 (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.
Postpartum depression (PD) is a serious and disabling mental health condition that affects 10-15% of women after childbirth. Low-income minority women are disproportionately affected. Untreated PD can lead to significant negative outcomes for both mother and child. Pediatricians are being asked to routinely screen for PD and while screening rates are improving, little is known about whether mothers actually adhere to pediatrician recommendations to seek additional help after a positive PD screen. The objective of this study is to describe the rate at which mothers seek treatment for suspected PD after a positive screen at the pediatrician office. Additional examination will look at factors that predict whether a mother recalls a recommendation to seek treatment.
Detailed description
The primary outcome of interest is whether mothers suspected of having PD seek treatment after discussion with the pediatrician. In order to evaluate whether discussion with pediatricians leads mothers to seek care, data collection efforts should focus on what information was exchanged, the level of shared decision-making about possible treatment options and whether an agreed upon plan was reached between both parties. The investigators will examine the effectiveness of these discussions by interviewing mothers who were suspected of having PD and referred for treatment. The investigators hypothesize that pediatricians who are able to engage mothers in a shared decision will result in more of those mothers seeking help and getting into appropriate treatment for PD.
The specific research aims of this proposal are to:
Aim 1: Describe the rate at which mothers suspected by pediatricians of having PD seek treatment.
Aim 2: Explore what factors predict whether mothers suspected of PD seek treatment, including maternal sociodemographic characteristics, family centeredness of pediatrician care, and extent of shared decision-making strategy used by the pediatrician.
This will be a cohort study examining the rate at which mothers suspected of having PD seek care and the relationship between shared decision-making and seeking mental health care. Data for both specific aims will be collected by a single telephone interview with mothers suspected of having PD by the pediatrician and referred. For this study, investigators will be focusing recruitment efforts in the four Wishard community health centers (now Eskenazi Health) that use CHICA. In 2007, these four clinics saw 8,528 patients between the ages of 0 and 3 years. These clinics serve a large proportion of families that are underserved, economically disadvantaged and are ethnically and racially diverse.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mothers whose children received care at one of 4 community general pediatrics clinic with the Child Health Improvement through Computer Automation (CHICA) system who had a positive PD screen and brought the child to the majority of the child's visits to the study clinic
Key inclusion criteria (1 listed)
- -mothers with a positive PD screen who brought their child to seek medical care at participating study clinics, who were present for a majority of the child's visits.
Key exclusion criteria (1 listed)
- -not biological mother, did not bring child to majority of clinic visits
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 |
|---|---|---|
| telephone interviewtelephone interview about their care received during the first year of life and associated events | Other | – |
Primary outcome
Rate at which mothers sought treatment for suspected PD
Time frame: Within 1 year of index visit
Defined broadly as a positive response to either called adult care provider (primary care provider, obstetrician, or mental health therapist) for appointment or community resource
1 secondary outcome
Factors associated with help seeking behavior
Time frame: Within 1 year of index visit
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 25 Sep 2015.
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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.
Nerissa S Bauer, MD, MPH principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Postpartum, run by Indiana University.
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 1 inclusion and 1 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 25 Sep 2015. 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?
Rate at which mothers sought treatment for suspected PD (time frame: Within 1 year of index visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2015.