PTSD Screening in Pregnant Black Women

Comparing Two Screening Approaches for PTSD to Improve Health Outcomes in Pregnant Black Women

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Pregnancy Early
• Intervention / Treatment: Behavioral: Culturally Responsive SBIRT for OB; Behavioral: Brief Screening for PTSD

Detailed Description

Researchers will examine whether Culturally Responsive Screening, Brief Intervention, and Referral to Treatment (SBIRT) for obstetrics (OB) is more effective in reducing PTSD symptoms compared to brief screening for PTSD. This study will help participating OB clinics to determine the best option for screening for PTSD in Black pregnant persons in their clinic during first-trimester prenatal visits.

The study population will include Black pregnant women receiving medical care in their first trimester of pregnancy. Surveys and chart abstraction will be used in this study to collect data. The approximate study duration for individuals is 4 visits over 12 months.

• Study Type: Interventional
• Enrollment (Estimated): 804
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abigail Powers Lott, PhD, ABPP; Phone Number: 404-712-0159; Email: abigail.lott@emoryhealthcare.org

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Recruiting
      • Grady Health System
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Truman Medical Center (TMC) system
      • Principal Investigator: Traci Johnson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18+ years old,
• Ability to provide informed consent,
• English-speaking,
• Willingness to participate in the study,
• Self-identification as Black or African American,
• Pregnant and in the first trimester attending initial prenatal care visit,
• Endorsement of at least one traumatic event in their lifetime.

Exclusion Criteria:

• Active suicidality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: Culturally Responsive SBIRT for OB; 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: 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;; explicit focus on concerns regarding mistrust,; psychoeducation on PTSD, depression, and the effects of trauma including medical trauma and traumatic loss on health/functioning,; 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,; teaching coping skills with culturally responsive technology tools; Other Names: Screening Preventive Intervention Model
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.	Behavioral: Brief Screening for PTSD; 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.; Other Names: Standard Screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score	Researchers will use the PTSD Checklist for DSM-5 (PCL-5) to measure PTSD symptoms, a well-validated and widely used 21-item measure that assesses the frequency of current PTSD symptoms. Participants report how often they have been bothered by specific symptoms of PTSD on a scale of 0 (not at all) to 4 (extremely). The total symptom severity score ranges from 0 to 80. A provisional PTSD diagnosis can be made and a PCL-5 cut-point score of 33 is recommended.	Initial OB visit (weeks 1-13), second trimester (Weeks 14 to 27), third trimester (weeks 28-40), and 6-weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy of prenatal care utilization (APNCU)	OB physicians widely use this measure. The APNCU includes what trimester prenatal care began within the index. APNCU is a standard metric, defined as attending at least 80% of prenatal care visits, adjusting for gestational age. Researchers will use chart abstraction to determine the percent attendance of prenatal care adjusting for gestational age at birth.	6 weeks postpartum

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Patient-Centered Outcomes Research Institute; University of Missouri, Kansas City
• Investigators: Principal Investigator: Abigail Lott, PhD, ABPP, Emory University; Principal Investigator: Briana Woods-Jaeger, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Estimated): October 27, 2025
• Last Update Submitted That Met QC Criteria: October 23, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; African-American Women; Black Women; Screening for Maternal PTSD; Obstetric Care
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: STUDY00007909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No