A program to support the mental health of Black pregnant women
Advancing Perinatal Mental Health and Well-Being: The DC Mother-Infant Behavioral Wellness Program
This study is testing a new support program to help low-income Black pregnant women manage stress, anxiety, and depression during pregnancy by combining peer support with tailored therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT05345834 on ClinicalTrials.gov |
What this trial studies
This randomized controlled program aims to evaluate the effectiveness of patient navigation combined with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black pregnant women facing stress, anxiety, and depression. The study will recruit 700 participants from urban prenatal care centers in Washington DC, who will be screened for mental health issues and randomized into either usual care or the intervention group. The goal is to create a community-based model of integrated perinatal mental health care that is tailored to the specific needs of this population.
Who should consider this trial
Good fit: Ideal candidates for this program are low-income Black pregnant women aged 18-45 who are experiencing stress, anxiety, or depression and are receiving prenatal care.
Not a fit: Patients who do not identify as Black or of African descent, are under 18, or are experiencing severe mental health crises may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve the mental health and well-being of low-income Black pregnant women, leading to better maternal and infant outcomes.
How similar studies have performed: Other studies have shown success with culturally tailored interventions for mental health, indicating potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Washington, District of Columbia
- Unity Healthcare - Brentwood — Washington, District of Columbia, United States (Recruiting)
Study contacts
- Study coordinator: Huynh-Nhu Le, PhD
- Email: hnle@gwu.edu
- Phone: (202) 994-6808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.