NCT00560027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
2.6 years until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

2.9 years

First QC Date

November 16, 2007

Last Update Submit

May 26, 2015

Conditions

Postpartum DepressionIntimate Partner Violence

Keywords

postpartum depressionintimate partner violence

Outcome Measures

Primary Outcomes (1)

  • Positive screens for PPD and/or IPV

    12 months

Secondary Outcomes (1)

  • Healthcare utilization over 2 years (acute care, emergency and well visits)

    12 months

Interventions

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.

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harriet Lane Clinic

Baltimore, Maryland, 21287, United States

Location

Related 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.

    PMID: 22404952BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Barry S Solomon, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Megan Bair-Merritt, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

July 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(1)