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

NCT ID: NCT04838210

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2026-06-30

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.

Conditions

Pregnancy Related; Perinatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group Prenatal Care

Group prenatal care model

Group Type: EXPERIMENTAL

EleVATE Group Care

Intervention Type: BEHAVIORAL

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.

Individual Prenatal Care

Individual prenatal care

Group Type: ACTIVE_COMPARATOR

Individual Prenatal Care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Missouri-Kansas City/Truman Health Centers-Kansas City

Kansas City, Missouri, United States

Affinia Healthcare

St Louis, Missouri, United States

Family Care Health Centers

St Louis, Missouri, United States

CareSTL Health

St Louis, Missouri, United States

Countries

United States

Other Identifiers

202103142

Identifier Type: -

Identifier Source: org_study_id