Case Management Study for Postpartum Depression and Intimate Partner Violence
Primary Purpose
Postpartum Depression, Intimate Partner Violence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Case Management by Family Support Counselor (not RCT)
Sponsored by
About this trial
This is an interventional screening trial for Postpartum Depression focused on measuring postpartum depression, intimate partner violence
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- none
Sites / Locations
- Harriet Lane Clinic
Outcomes
Primary Outcome Measures
Positive screens for PPD and/or IPV
Secondary Outcome Measures
Healthcare utilization over 2 years (acute care, emergency and well visits)
Full Information
NCT ID
NCT00560027
First Posted
November 16, 2007
Last Updated
May 26, 2015
Sponsor
Johns Hopkins University
Collaborators
Leonard & Helen R. Stulman Charitable Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00560027
Brief Title
Case Management Study for Postpartum Depression and Intimate Partner Violence
Official Title
Screening, Referral and Case Management for Postpartum Depression and Intimate Partner Violence in an Urban Pediatric Practice
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Leonard & Helen R. Stulman Charitable Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Intimate Partner Violence
Keywords
postpartum depression, intimate partner violence
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Case Management by Family Support Counselor (not RCT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive screens for PPD and/or IPV
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Healthcare utilization over 2 years (acute care, emergency and well visits)
Time Frame
12 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry S Solomon, MD, MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Megan Bair-Merritt, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harriet Lane Clinic
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22404952
Citation
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.
Results Reference
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Case Management Study for Postpartum Depression and Intimate Partner Violence
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