Trials / Active Not Recruiting
Active Not RecruitingNCT04838210
Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 416 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- Female
- Age
- 13 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | EleVATE Group Care | 10-session (2 hours per session) group prenatal care model following the prenatal visit schedule recommended by ACOG. In addition to pregnancy and infant-care related content, the EleVATE GC curriculum includes behavioral health strategies that can be used to manage depression and labor pain and navigate the daily frustrations and stress of life. Groups are facilitated by an obstetric clinician. |
| BEHAVIORAL | Individual Prenatal Care | The dominant model of prenatal care in the United States, consisting of one-on-one encounters between a patient and obstetric clinician. Patients are seen for 10-15 mins every 4 weeks until 28 weeks gestation, every 2 weeks until 37 weeks or more by provider discretion), and weekly until delivery. Visits focus on routine screening tests and prenatal care. |
Timeline
- Start date
- 2021-05-21
- Primary completion
- 2025-12-03
- Completion
- 2026-06-30
- First posted
- 2021-04-09
- Last updated
- 2026-01-20
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04838210. Inclusion in this directory is not an endorsement.