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

November 16, 2007
November 16, 2007
January 2008
Not Provided
Community service use (engagement with mental health services or resources related to intimate partner violence) [ Time Frame: 12 months ]
Same as current
No Changes Posted
safety promoting behaviors, compliance with recommended well-child care, and number of acute care medical visits [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
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

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?

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Postpartum Depression
  • Intimate Partner Violence
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).
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
250
July 2009
Not Provided

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
Female
Not Provided
Yes
Contact: Barry S Solomon, MD, MPH 410-614-8438 bsolomo1@jhmi.edu
Contact: Megan Bair-Merritt, MD, MHS 410-614-3863 mbairme1@jhmi.edu
United States
 
NCT00560027
20064046
No
Not Provided
Johns Hopkins University
Leonard & Helen R. Stulman Charitable Foundation
Principal Investigator: Barry S Solomon, MD, MPH Johns Hopkins University
Principal Investigator: Megan Bair-Merritt, MD, MHS Johns Hopkins University
Johns Hopkins University
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP