Case Management Study for Postpartum Depression and Intimate Partner Violence

Postpartum Depression Clinical Trial

Official title:

Screening, Referral and Case Management for Postpartum Depression and Intimate Partner Violence in an Urban Pediatric Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560027
• Other study ID #: 20064046
• Status: Completed
• Phase: N/A
• First received: November 16, 2007
• Last updated: May 26, 2015
• Start date: July 2010
• Est. completion date: June 2013

Study information

• Verified date: May 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 utilization from birth to 2 years.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Intimate Partner Violence
• Postpartum Depression

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Harriet Lane Clinic	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Leonard & Helen R. Stulman Charitable Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive screens for PPD and/or IPV		12 months
Secondary	Healthcare utilization over 2 years (acute care, emergency and well visits)		12 months