Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
- Conditions
- Pregnancy RelatedPerinatal Depression
- Interventions
- Behavioral: Individual Prenatal CareBehavioral: EleVATE Group Care
- Registration Number
- NCT04838210
- Lead Sponsor
- Washington University School of Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 390
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individual Prenatal Care Individual Prenatal Care Individual prenatal care Group Prenatal Care EleVATE Group Care Group prenatal care model
- Primary Outcome Measures
Name Time Method Perinatal Depression 4-12 weeks Postpartum Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
- Secondary Outcome Measures
Name Time Method Preterm Birth Delivery Delivery at \<37 weeks gestation
Anxiety 4-12 weeks Postpartum PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome
Social Support 4-12 weeks Postpartum PROMIS Bank 2.0 Social Support (emotional support, instrumental support, informational support, and social isolation domains) T-Scores, range 23.7-76.9, higher scores are better outcomes for emotional support, instrumental support and informational support, higher scores are worse outcomes for social isolation
Small for Gestational Age Delivery Birthweight \<10th percentile on the Alexander growth curve
Perceived Stress 4-12 weeks Postpartum Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome
Post-Traumatic Stress Disorder (PTSD) Baseline Visit PTSD Checklist for DSM-V Total Symptom Severity Score, range 0-80, higher scores are a worse outcome
Race-Related Stress Baseline visit Index of Race Related Stress-Brief Version Total Score, range 0-22, higher scores are worse outcomes
Maternal Attachment (Postnatal) 4-12 Weeks Postpartum Maternal Postnatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes
Maternal Attachment (Antenatal) 28-40 week visit Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes
Trial Locations
- Locations (4)
University of Missouri-Kansas City/Truman Health Centers-Kansas City
🇺🇸Kansas City, Missouri, United States
CareSTL Health
🇺🇸Saint Louis, Missouri, United States
Family Care Health Centers
🇺🇸Saint Louis, Missouri, United States
Affinia Healthcare
🇺🇸Saint Louis, Missouri, United States