The DC Mother-Infant Behavioral Wellness Program (NCT05345834) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The DC Mother-Infant Behavioral Wellness Program
United States700 participantsStarted 2022-08-22
Plain-language 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 Descent pregnant women who are experiencing stress, anxiety, and/or depression.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Stress at 24 weeks of pregnancy to 12 months postpartum
Timeframe: Stress will be measured at 24 weeks of pregnancy through infant age of 12 months
2
Change in Depression at 24 weeks of pregnancy to 12 months postpartum