PTSD Screening in Pregnant Black Women

ConditionsPregnancy Early PTSD

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorEmory University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18+ years old,

Ability to provide informed consent,

English-speaking,

Willingness to participate in the study,

Disqualifiers

Active suicidality

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

804 Participants

are divided into 2 treatment groups

Group A: Culturally Responsive SBIRT for OBExperimental treatment 1 intervention

Group B: Brief Screening for PTSDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Initial OB visit (weeks 1-13), second trimester (Weeks 14 to 27), third trimester (weeks 28-40), and 6-weeks postpartum

Secondary outcomes

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.

Time frame

6 weeks postpartum

Sponsors and contacts

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Emory University

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

University of Missouri, Kansas City