PTSD Screening in Pregnant Black Women

NCT06522022 | Recruiting

• 1 other identifier: STUDY00007909
• Study Type: interventional
• Target: 804
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pregnancy Early; PTSD

Keywords

Pregnancy; Black Women; Screening for Maternal PTSD; Obstetric Care; African-American Women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adequacy of prenatal care utilization (APNCU)

  6 weeks postpartum

Study Arms (2)

Culturally Responsive SBIRT for OB

EXPERIMENTAL

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

Brief Screening for PTSD

EXPERIMENTAL

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

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

Also known as: Screening Preventive Intervention Model

Culturally Responsive SBIRT for OB

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.

Also known as: Standard Screening

Brief Screening for PTSD

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant Females in their first trimester
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• Active suicidality

Sponsors & Collaborators

• Emory University: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Missouri, Kansas City: collaborator

Study Sites (2)

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

Truman Medical Center (TMC) system

Kansas City, Missouri, 64108, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Abigail Lott, PhD, ABPP

  Emory University

  PRINCIPAL INVESTIGATOR

• Briana Woods-Jaeger, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Powers Lott, PhD, ABPP

CONTACT

404-712-0159; abigail.lott@emoryhealthcare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)