Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care (NCT04838210) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
United States416 participantsStarted 2021-05-21
Plain-language summary
This study will provide high-quality, representative data on the capacity of Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care (EleVATE GC) to reduce perinatal depression, preterm birth, and low birthweight in African-American women. If findings from this study indicate that EleVATE GC is feasible and effective, this model could be implemented nationwide to help achieve mental and obstetric health parity for low-income women of color in the United States.
Who can participate
Age range
13 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:
* English or Spanish speaking
* ≤18 weeks' gestation
* Established prenatal care at EleVATE site
* High-risk for postpartum depression by ≥1 risk factor (personal/family history, baseline EPDS≥10, low-income, 13-19 years old, single, history of physical/sexual abuse, unplanned/undesired pregnancy, history of pregnancy loss)
* Ability to attend group prenatal visits at specified days/times
* Willingness to be randomized
* Ability to give informed consent
* Any patient that has received prenatal care in a group setting previously
Exclusion Criteria:
* Multiple gestation
* Major fetal anomaly
* Serious medical co-morbidity/psychiatric illness necessitating more care than can be safely provided in group setting
* Serious medical co-morbidity necessitating more care than can be safely provided in group setting
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.