Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care (EleVATE GC)
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About
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.
Enrollment
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
390 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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