Case Management Study for Postpartum Depression and Intimate Partner Violence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Johns Hopkins University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Leonard & Helen R. Stulman Charitable Foundation
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00560027
First received: November 16, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

The goals of this randomized clinical trial are to address the following questions: 1) What is the prevalence of postpartum depression (PPD), intimate partner violence (IPV) and co-occurrence of the two in mothers bringing their infants to an urban pediatric primary care clinic for health maintenance visits?; 2) Compared to standard screening and referral, do mothers screening positive for PPD and/or IPV who are assigned to a case management intervention have increased safety promoting behaviors and higher rates of engagement with mental health services and community resources?; and 3) Compared to standard screening and referral, do infants of mothers screening positive for PPD and/or IPV who are assigned to a case management intervention have greater compliance with well-child care and fewer acute care visits?


Condition Intervention
Postpartum Depression
Intimate Partner Violence
Behavioral: Case Management by Family Support Counselor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Screening, Referral and Case Management for Postpartum Depression and Intimate Partner Violence in an Urban Pediatric Practice

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Community service use (engagement with mental health services or resources related to intimate partner violence) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • safety promoting behaviors, compliance with recommended well-child care, and number of acute care medical visits [ Time Frame: 12 months ]

Estimated Enrollment: 250
Study Start Date: January 2008
Estimated Study Completion Date: July 2009
Intervention Details:
    Behavioral: Case Management by Family Support Counselor
    Mothers in the intervention group who screen positive for postpartum depression (PPD) and/or intimate partner violence (IPV) will be given the Family Support Counselor's (FSC) contact information and will receive routine phone calls, at a number deemed safe by the mother, to provide ongoing support up through the child's first birthday. Mothers screening positive for IPV will be provided with a guide of safety-promoting behaviors. The FSC will contact mothers weekly for the first month, then bi-weekly for the second month, then monthly until the child's first birthday. The FSC will use a standardized tool to track the content of these calls. The FSC will also meet with mothers when they return to the Harriet Lane Clinic for their infant's medical visits (both sick and well visits).
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 current research will be conducted using a randomized controlled trial design to compare the effectiveness of a standard screening and referral practice to an intensive case management intervention for mothers screening positive for PPD and/or IPV. The following research questions will be addressed in this study: 1) What is the prevalence of postpartum depression (PPD), intimate partner violence (IPV) and co-occurrence of the two in mothers bringing their infants to an urban pediatric primary care clinic for health maintenance visits? 2) Compared to standard screening and referral, do mothers screening positive for PPD and/or IPV who are assigned to a case management intervention have increased safety promoting behaviors and higher rates of engagement with mental health services and community resources? 3) Compared to standard screening and referral, do infants of mothers screening positive for PPD and/or IPV who are assigned to a case management intervention have greater compliance with well-child care and fewer acute care visits?

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) will be 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. After this is complete, eligible mothers will be recruited to participate in the study which will follow the above-described outcomes. There are 10 clinic sessions, (representing morning and afternoon each weekday) where pediatric residents serve as primary care providers and are supervised by board-certified pediatricians. The 10 clinic sessions will be randomized (5 case management intervention sessions and 5 standard practice sessions). Once consent is obtained, for positive screening mothers, based on the clinic session assignment, the FSC will enroll the mother/infant dyad into either the intervention (intensive case management) or standard practice group. All consenting mothers will be followed every three months through the child's first birthday by telephone using a standardized assessment survey and by child medical record review.

For negative screening mothers, consent will be obtained to track their PPD and IPV screening responses and demographic data and to access their child's medical records through the child's 1st birthday. Data from mother's screening negative for PPD and IPV will be followed for three reasons: 1) this information will be used in the PPD/IPV prevalence estimations; 2) women screening negative at one visit may become positive at the next; keeping track of their data, therefore, will allow us to better describe the natural time course of PPD and IPV in the post-partum period; and 3) data from this group will serve as a control group for the randomized trial (particularly with regard to infants' health service use).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560027

Contacts
Contact: Barry S Solomon, MD, MPH 410-614-8438 bsolomo1@jhmi.edu
Contact: Megan Bair-Merritt, MD, MHS 410-614-3863 mbairme1@jhmi.edu

Locations
United States, Maryland
Harriet Lane Clinic Not yet recruiting
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Leonard & Helen R. Stulman Charitable Foundation
Investigators
Principal Investigator: Barry S Solomon, MD, MPH Johns Hopkins University
Principal Investigator: Megan Bair-Merritt, MD, MHS Johns Hopkins University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00560027     History of Changes
Other Study ID Numbers: 20064046
Study First Received: November 16, 2007
Last Updated: November 16, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
postpartum depression
intimate partner violence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on August 19, 2014