Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 416
- Locations
- 5
- Primary Endpoint
- Perinatal Depression
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group Prenatal Care
Group prenatal care model
Intervention: EleVATE Group Care (Behavioral)
Individual Prenatal Care
Individual prenatal care
Intervention: Individual Prenatal Care (Behavioral)
Outcomes
Primary Outcomes
Perinatal Depression
Time Frame: 4-12 weeks Postpartum
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Perinatal Depression
Time Frame: Baseline visit
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Perinatal Depression
Time Frame: 28-40 week visit
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Secondary Outcomes
- Preterm Birth(Delivery)
- Anxiety(4-12 weeks Postpartum)
- Social Support(4-12 weeks Postpartum)
- Small for Gestational Age(Delivery)
- Perceived Stress(4-12 weeks Postpartum)
- Post-Traumatic Stress Disorder (PTSD)(Baseline Visit)
- Race-Related Stress(Baseline visit)
- Maternal Attachment (Postnatal)(4-12 Weeks Postpartum)
- Maternal Attachment (Antenatal)(28-40 week visit)
- Perceived Stress(Baseline visit)
- Perceived Stress(28-40 week)
- Anxiety(Baseline visit)
- Anxiety(28-40 week visit)
- Social Support(Baseline visit)
- Social Support(28-40 week visit)
- Maternal Attachment (Antenatal)(Baseline visit)