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

NCT04838210 | Active Not Recruiting DMC

• 1 other identifier: 202103142
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (3)

• Perinatal Depression

  Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)

  Baseline visit

• Perinatal Depression

  Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)

  28-40 week visit

• Perinatal Depression

  Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)

  4-12 weeks Postpartum

Secondary Outcomes (16)

• Preterm Birth

  Delivery

• Small for Gestational Age

  Delivery

• Perceived Stress

  Baseline visit

• Perceived Stress

  28-40 week

• Perceived Stress

  4-12 weeks Postpartum

Study Arms (2)

Group Prenatal Care

EXPERIMENTAL

Group prenatal care model

Behavioral: EleVATE Group Care

Individual Prenatal Care

ACTIVE COMPARATOR

Individual prenatal care

Behavioral: Individual Prenatal Care

Interventions

EleVATE Group Care 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.

Group Prenatal Care

Individual Prenatal Care 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.

Individual Prenatal Care

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (4)

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

Kansas City, Missouri, 64108, United States

Location

Affinia Healthcare

St Louis, Missouri, 63104, United States

Location

Family Care Health Centers

St Louis, Missouri, 63111, United States

Location

CareSTL Health

St Louis, Missouri, 63112, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: April 9, 2021
• Study Start: May 21, 2021
• Primary Completion: December 3, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (4)