Status:
ACTIVE_NOT_RECRUITING
The DC Mother-Infant Behavioral Wellness Program
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
George Washington University
Patient-Centered Outcomes Research Institute
Conditions:
Perinatal Depression
Perinatal Anxiety
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
This randomized controlled study will examine the effectiveness of patient navigation with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black/of African...
Detailed Description
The overarching objective is to develop and evaluate a collaborative, multi-dimensional and culturally tailored community-based model of integrated perinatal MH care. The target population is low-inco...
Eligibility Criteria
Inclusion
- Black/of African Descent
- Pregnant (gestational weeks ≤ 28 weeks)
- Age 18-45
- English proficient
- Receiving services in 1 of 4 study sites above
- Low-income: i.e., receiving Medicaid
- Subthreshold or threshold risk for maternal distress (stress, depression, and/or anxiety)
- Able to provide consent
Exclusion
- age \<18
- Currently under the influence of a substance(s)
- Experiencing psychosis
- Critical (clinical) risk: actively suicidal or homicidal
- Not Black/of African Descent
- Planning to deliver outside DC
Key Trial Info
Start Date :
August 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT05345834
Start Date
August 22 2022
End Date
November 30 2026
Last Update
July 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Unity Healthcare - Brentwood
Washington D.C., District of Columbia, United States, 20018