Case Management Study for Postpartum Depression and Intimate Partner Violence
Recruitment status was Not yet recruiting
|First Received Date ICMJE||November 16, 2007|
|Last Updated Date||November 16, 2007|
|Start Date ICMJE||January 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Community service use (engagement with mental health services or resources related to intimate partner violence) [ Time Frame: 12 months ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||safety promoting behaviors, compliance with recommended well-child care, and number of acute care medical visits [ Time Frame: 12 months ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Case Management Study for Postpartum Depression and Intimate Partner Violence|
|Official Title ICMJE||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).
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Intervention ICMJE||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).
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||250|
|Estimated Completion Date||July 2009|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00560027|
|Other Study ID Numbers ICMJE||20064046|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Johns Hopkins University|
|Collaborators ICMJE||Leonard & Helen R. Stulman Charitable Foundation|
|Information Provided By||Johns Hopkins University|
|Verification Date||November 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP