Pregnancy EarlyNCT06522022
PTSD Screening in Pregnant Black Women
A study testing Culturally Responsive SBIRT for OB and Brief Screening for PTSD in people with Pregnancy Early and PTSD, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Early, PTSD
- What is being tested?
- Culturally Responsive SBIRT for OB and Brief Screening for PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Feb 2025to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Active suicidality
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
- Recruiting
Truman Medical Center (TMC) system
Kansas City, Missouri, 64108
Traci Johnson, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Early, PTSD
- Being tested
- Culturally Responsive SBIRT for OB, Brief Screening for PTSD
- Keywords
- Pregnancy, Black Women, Screening for Maternal PTSD, Obstetric Care, African-American Women
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Responsive SBIRT for OBBehavioural
Also called Screening Preventive Intervention Model
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
Brief Screening for PTSDBehavioural
Also called Standard Screening
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Brief Screening for PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start20 Feb 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy EarlyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 804 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Missouri, Kansas City
- Responsible party
- Principal investigator, Abigail Lott, Emory University
- Investigators
- Abigail Lott, PhD, ABPP, Principal investigator, Emory UniversityBriana Woods-Jaeger, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522022
- Sponsor's protocol ID
- STUDY00007909
- Other IDs
- 2025P013179
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Screening Approaches for PTSD to Improve Health Outcomes in Pregnant Black Women
- ClinicalTrials.gov ID
- NCT06522022
- Acronym / sponsor ID
- STUDY00007909
- Conditions
- Pregnancy Early, PTSD
- Keywords
- Pregnancy, Black Women, Screening for Maternal PTSD, Obstetric Care, African-American Women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 804 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Missouri, Kansas City
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally Responsive SBIRT for OB | Experimental | Behavioral: Culturally Responsive SBIRT for OBParticipants 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 |
| Brief Screening for PTSD | Experimental | Behavioral: Brief Screening for PTSDParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18+ years old,
- Ability to provide informed consent,
- English-speaking,
- Willingness to participate in the study,
- Self-identification as Black or African American,
Key exclusion criteria (1 listed)
- Active suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Responsive SBIRT for OBAlso: Screening Preventive Intervention ModelSBIRT 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 | Behavioural | Culturally Responsive SBIRT for OB |
| Brief Screening for PTSDAlso: Standard ScreeningThis 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. | Behavioural | Brief Screening for PTSD |
Primary outcome
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
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.
1 secondary outcome
Adequacy of prenatal care utilization (APNCU)
Time frame: 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abigail Lott, PhD, ABPP principal investigator
Emory University
Briana Woods-Jaeger, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Responsive SBIRT for OB and Brief Screening for PTSD in people with Pregnancy Early and PTSD, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abigail Powers Lott, PhD, ABPP (404-712-0159, abigail.lott@emoryhealthcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.