Case Management Study for Postpartum Depression and Intimate Partner Violence
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|ClinicalTrials.gov Identifier: NCT00560027|
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : May 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Depression Intimate Partner Violence||Other: Case Management by Family Support Counselor (not RCT)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||173 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Screening, Referral and Case Management for Postpartum Depression and Intimate Partner Violence in an Urban Pediatric Practice|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Other: Case Management by Family Support Counselor (not RCT)
- Positive screens for PPD and/or IPV [ Time Frame: 12 months ]
- Healthcare utilization over 2 years (acute care, emergency and well visits) [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560027
|United States, Maryland|
|Harriet Lane Clinic|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Barry S Solomon, MD, MPH||Johns Hopkins University|
|Principal Investigator:||Megan Bair-Merritt, MD, MHS||Johns Hopkins University|