Case Management Study for Postpartum Depression and Intimate Partner Violence

Official Title: “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).

Intervention(s) in this Clinical Trial

• 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).

Primary Measures

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

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Johns Hopkins University Other

Overall Clinical Trial Officials and Contacts

Barry S Solomon, MD, MPH Principal Investigator Johns Hopkins University  

Overall Contact: Barry S Solomon, MD, MPH 410-614-8438 bsolomo1@jhmi.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00560027

Study ID Number: 20064046

ClinicalTrials.gov Identifier: NCT00560027

Health Authority: United States: Institutional Review Board