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Behavioral Intervention

Culturally Responsive SBIRT for OB for Post-Traumatic Stress Disorder

N/A
Waitlist Available
Led By Abigail Lott, PhD, ABPP
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 18+ years old
* Ability to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial ob visit (weeks 1-13), second trimester (weeks 14 to 27), third trimester (weeks 28-40), and 6-weeks postpartum
Awards & highlights

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.

Who is the study for?
This trial is for Black pregnant women who may have PTSD. It's designed to see if certain screening methods can help improve their mental health, satisfaction with care, and birth outcomes.
What is being tested?
The study compares two approaches: a brief screening for PTSD and a culturally responsive SBIRT (Screening, Brief Intervention, and Referral to Treatment) specifically tailored for obstetrics.
What are the potential side effects?
Since the interventions involve non-invasive screenings rather than medications or procedures, there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initial ob visit (weeks 1-13), second trimester (weeks 14 to 27), third trimester (weeks 28-40), and 6-weeks postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and initial ob visit (weeks 1-13), second trimester (weeks 14 to 27), third trimester (weeks 28-40), and 6-weeks postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score
Secondary study objectives
Adequacy of prenatal care utilization (APNCU)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Culturally Responsive SBIRT for OBExperimental Treatment1 Intervention
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
Group II: Brief Screening for PTSDExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Missouri, Kansas CityOTHER
70 Previous Clinical Trials
32,620 Total Patients Enrolled
Emory UniversityLead Sponsor
1,665 Previous Clinical Trials
2,574,281 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
568 Previous Clinical Trials
30,055,810 Total Patients Enrolled
~536 spots leftby Mar 2029