PTSD Screening in Pregnant Black Women

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06522022
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Culturally Responsive SBIRT for OB — BEHAVIORAL
    SBIRT is a well-established enhanced screening preventive intervention model that is feasible and acceptable for use with trauma-exposed patients and in minoritized communities and can be delivered in the OB clinic during a prenatal care visit. The elements include: 1. standardized screening for PTSD and depression using the Primary Care Post Traumatic Stress Disorder Screen (PC-PTSD-5) and the Edinburgh Postnatal Depression Screening (EPDS) that will mirror brief screening practice; 2. explicit focus on concerns regarding mistrust, 3. psychoeducation on PTSD, depression, and the effects of trauma including medical trauma and traumatic loss on health/functioning, 4. motivational interviewing strategy components to promote awareness of psychological symptoms and engagement in culturally relevant resources including support/resources related to relevant social determinants of health, 5. teaching coping skills with culturally responsive technology tools
  • Brief Screening for PTSD — BEHAVIORAL
    This well-established 5-minute in-clinic interview includes administration of the PC-PTSD-5, a 5-item PTSD screening tool by trained medical staff (nurse, physician's assistant). Providers receive approximately one hour of training in trauma-informed care and how to administer the screening protocol. This method is regularly used in primary care clinic settings with trauma-exposed veterans and is validated for use in civilian samples, including low-income Black adults utilizing urban safety net hospital medical clinics.

Study Details

This study will compare the effectiveness of two active screening interventions in improving post-traumatic stress disorder (PTSD) symptoms, maternal perinatal care utilization, satisfaction utilization of mental healthcare services, and maternal health and birth-related outcomes for Black pregnant women.

Key Dates

Start date
Feb 20, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
804 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Culturally Responsive SBIRT for OB
    Participants randomized to Culturally Responsive SBIRT for OB will participate in the intervention visit (20-30 minutes) while waiting for their OB visit (or after the visit if time does not allow) and then engage in their prenatal care visit as usual. If any safety concerns emerge during the visit, the lay provider will contact the clinical staff on the study
  • Experimental: Brief Screening for PTSD
    Participants randomized to Brief Screening For PTSD, screening will be conducted as part of regular clinic activities during the initial prenatal care visit. Specifically, clinic staff (nurse, PA) or study staff will ask the questions in the PC-PTSD-5 along with the standard procedure to administer the Edinburgh Postnatal Depression Scale (EPDS), and the provider will review the results with the patient during the prenatal care visit and provide referral resources regardless of screen outcome. Positive PTSD screens (PC-PTSD-5 ≥ 3) will be referred to the hospital's integrated care team following the same model as positive EPDS screens.

Primary Outcome Measure

PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score [ Time Frame: Initial OB visit (weeks 1-13), second trimester (Weeks 14 to 27), third trimester (weeks 28-40), and 6-weeks postpartum ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Grady Health SystemAtlantaGeorgia30303-
Truman Medical Center (TMC) systemKansas CityMissouri64108
Traci Johnson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Grady Health System· Atlanta, GATruman Medical Center (TMC) system· Kansas City, MO

Related Studies