- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00560027
Case Management Study for Postpartum Depression and Intimate Partner Violence
Screening, Referral and Case Management for Postpartum Depression and Intimate Partner Violence in an Urban Pediatric Practice
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Harriet Lane Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Positive screens for PPD and/or IPV
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Healthcare utilization over 2 years (acute care, emergency and well visits)
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Barry S Solomon, MD, MPH, Johns Hopkins University
- Principal Investigator: Megan Bair-Merritt, MD, MHS, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20064046
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