Case Management Study for Postpartum Depression and Intimate Partner Violence
Recruitment status was Not yet recruiting
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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 |
- Community service use (engagement with mental health services or resources related to intimate partner violence) [ Time Frame: 12 months ]
- 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 |
-
Behavioral: Case Management by Family Support Counselor
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 |
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| 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, Maryland | |
| Harriet Lane Clinic | Not yet recruiting |
| Baltimore, Maryland, United States, 21287 | |
| 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 May 19, 2013