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Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care

NCT04838210 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2026-01-20

No results posted yet for this study

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

  • Pregnancy Related
  • Perinatal Depression

Interventions

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2025-12-03
Completion
2026-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04838210 on ClinicalTrials.gov