Postpartum DepressionNCT00560027
Case Management Study for Postpartum Depression and Intimate Partner Violence
A study testing Case Management by Family Support Counselor (not RCT) in people with Postpartum Depression and Intimate Partner Violence, run by Johns Hopkins University at 1 site in United States.
Trial summary
The objective of the study was to assess the prevalence, timing, and co-occurrence of positive screens for maternal postpartum depression (PPD) and intimate partner violence (IPV) for women bringing their young infants for pediatric primary care and examine relationships between PPD, IPV and children's healthcare… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Intimate Partner Violence
- What is being tested?
- Case Management by Family Support Counselor (not RCT)
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2013
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English-speaking mothers of infants presenting for their newborn, two, four or six month visits to their primary care provider in the Harriet Lane Clinic
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening, Referral and Case Management for Postpartum Depression and Intimate Partner Violence in an Urban Pediatric Practice
The objective of the study was to assess the prevalence, timing, and co-occurrence of positive screens for maternal postpartum depression (PPD) and intimate partner violence (IPV) for women bringing their young infants for pediatric primary care and examine relationships between PPD, IPV and children's healthcare utilization from birth to 2 years.
Read the detailed description
Post-partum depression (PPD) and intimate partner violence (IPV) negatively affect the health and well-being of millions of women each year. In turn, PPD and IPV frequently compromise women's ability to form a strong mother-infant bond, which potentially impacts their children's health and well-being. Limited information exists regarding the prevalence of PPD, IPV, and the co-occurrence of the two. Similarly, empirically tested interventions designed to improve outcomes for these women and their infants are lacking.
The objective of the research was to assess the prevalence, timing, and co-occurrence of positive screens for maternal postpartum depression and intimate partner violence and examine their relationships with children's healthcare utilization from birth to 2 years.
As per routine protocol in the Harriet Lane Clinic (HLC), all mothers bringing their infants for a well baby visit (birth to 6 month visit) are screened for PPD and IPV using a brief, self-administered paper-based questionnaire at the start of the visit. Appropriate resource and referral materials will be provided by a Family Support Counselor (FSC) in the clinic. Between February and March 2008, mothers bringing newborn, 2-, 4-, or 6-month-old children to an urban primary care clinic were screened for postpartum depression and intimate partner violence. A retrospective chart review abstracted demographic data, maternal responses on the postpartum depression/intimate partner violence screen at the initial and subsequent visits, and, from the child's birth to second birthday, adherence with well-child care and use of pediatric acute care and emergency department visits. Descriptive, bivariate, and multivariate analyses were conducted.
- Conditions
- Postpartum Depression, Intimate Partner Violence
- Being tested
- Case Management by Family Support Counselor (not RCT)
- Keywords
- postpartum depression, intimate partner violence
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case Management by Family Support Counselor (not RCT)Other
N/A. Had planned to study RCT of case management intervention but unable to carry out RCT. Instead studied screening practice and healthcare utilization in mothers with PPD, IPV or both.
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive screens for PPD and/or IPV
Measured: 12 months
Secondary outcomes (1)
Healthcare utilization over 2 years (acute care, emergency and well visits)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startJul 2010
- Primary completionJun 2013
- Study completionJun 2013
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 Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Leonard & Helen R. Stulman Charitable Foundation
- Responsible party
- Principal investigator, Barry Solomon, Johns Hopkins University
- Investigators
- Barry S Solomon, MD, MPH, Principal investigator, Johns Hopkins UniversityMegan Bair-Merritt, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560027
- Sponsor's protocol ID
- 20064046
- Status last verified
- May 2015
- First submitted
- 16 Nov 2007
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kornfeld BD, Bair-Merritt MH, Frosch E, Solomon BS. Postpartum depression and intimate partner violence in urban mothers: co-occurrence and child healthcare utilization. J Pediatr. 2012 Aug;161(2):348-53.e2. doi: 10.1016/j.jpeds.2012.01.047. Epub 2012 Mar 8.
PubMed 22404952
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening, Referral and Case Management for Postpartum Depression and Intimate Partner Violence in an Urban Pediatric Practice
- ClinicalTrials.gov ID
- NCT00560027
- Acronym / sponsor ID
- 20064046
- Conditions
- Postpartum Depression, Intimate Partner Violence
- Keywords
- postpartum depression, intimate partner violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Leonard & Helen R. Stulman Charitable Foundation
- Study start
- Jul 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Nov 2007 (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 objective of the study was to assess the prevalence, timing, and co-occurrence of positive screens for maternal postpartum depression (PPD) and intimate partner violence (IPV) for women bringing their young infants for pediatric primary care and examine relationships between PPD, IPV and children's healthcare utilization from birth to 2 years.
Detailed description
Post-partum depression (PPD) and intimate partner violence (IPV) negatively affect the health and well-being of millions of women each year. In turn, PPD and IPV frequently compromise women's ability to form a strong mother-infant bond, which potentially impacts their children's health and well-being. Limited information exists regarding the prevalence of PPD, IPV, and the co-occurrence of the two. Similarly, empirically tested interventions designed to improve outcomes for these women and their infants are lacking.
The objective of the research was to assess the prevalence, timing, and co-occurrence of positive screens for maternal postpartum depression and intimate partner violence and examine their relationships with children's healthcare utilization from birth to 2 years.
As per routine protocol in the Harriet Lane Clinic (HLC), all mothers bringing their infants for a well baby visit (birth to 6 month visit) are screened for PPD and IPV using a brief, self-administered paper-based questionnaire at the start of the visit. Appropriate resource and referral materials will be provided by a Family Support Counselor (FSC) in the clinic. Between February and March 2008, mothers bringing newborn, 2-, 4-, or 6-month-old children to an urban primary care clinic were screened for postpartum depression and intimate partner violence. A retrospective chart review abstracted demographic data, maternal responses on the postpartum depression/intimate partner violence screen at the initial and subsequent visits, and, from the child's birth to second birthday, adherence with well-child care and use of pediatric acute care and emergency department visits. Descriptive, bivariate, and multivariate analyses were conducted.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking mothers of infants presenting for their newborn, two, four or six month visits to their primary care provider in the Harriet Lane Clinic
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Case Management by Family Support Counselor (not RCT)N/A. Had planned to study RCT of case management intervention but unable to carry out RCT. Instead studied screening practice and healthcare utilization in mothers with PPD, IPV or both. | Other | – |
Primary outcome
Positive screens for PPD and/or IPV
Time frame: 12 months
1 secondary outcome
Healthcare utilization over 2 years (acute care, emergency and well visits)
Time frame: 12 months
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 28 May 2015.
- Background: PubMed 22404952Kornfeld BD, Bair-Merritt MH, Frosch E, Solomon BS. Postpartum depression and intimate partner violence in urban mothers: co-occurrence and child healthcare utilization. J Pediatr. 2012 Aug;161(2):348-53.e2. doi: 10.1016/j.jpeds.2012.01.047. Epub 2012 Mar 8.
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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.
Barry S Solomon, MD, MPH principal investigator
Johns Hopkins University
Megan Bair-Merritt, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Management by Family Support Counselor (not RCT) in people with Postpartum Depression and Intimate Partner Violence, run by Johns Hopkins University 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 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 28 May 2015. 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?
Positive screens for PPD and/or IPV (time frame: 12 months). 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 NCT00560027, 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 28 May 2015.