Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT06522022

Conditions

Pregnancy Early

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Culturally Responsive SBIRT for OB

Brief Screening for PTSD

Study Details

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

Study ID

NCT06522022

Start date

Feb 20, 2025

Status verified date

Oct, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

804 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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:

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

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.

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 and Locations

Central contacts

Abigail Powers Lott, PhD, ABPP

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

Locations

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Truman Medical Center (TMC) system

Recruiting

Kansas City, Missouri, United States, 64108

Principal Investigator:

Traci Johnson, MD

More Information

Sponsor

Emory University

Last update posted

Oct 27, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Emory University on 2025-10-27.