Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care (EleVATE GC)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy Related; Perinatal Depression
• Intervention / Treatment: Behavioral: EleVATE Group Care; Behavioral: Individual Prenatal Care

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • University of Missouri-Kansas City/Truman Health Centers-Kansas City
    • Saint Louis, Missouri, United States, 63104
      • Affinia Healthcare
    • Saint Louis, Missouri, United States, 63111
      • Family Care Health Centers
    • Saint Louis, Missouri, United States, 63112
      • CareSTL Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Prenatal Care; Group prenatal care model	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.
Active Comparator: Individual Prenatal Care; Individual prenatal care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm Birth	Delivery at <37 weeks gestation	Delivery
Small for Gestational Age	Birthweight <10th percentile on the Alexander growth curve	Delivery
Perceived Stress	Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome	Baseline visit
Perceived Stress	Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome	28-40 week
Perceived Stress	Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome	4-12 weeks Postpartum
Anxiety	PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome	Baseline visit
Anxiety	PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome	28-40 week visit
Anxiety	PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome	4-12 weeks Postpartum
Post-Traumatic Stress Disorder (PTSD)	PTSD Checklist for DSM-V Total Symptom Severity Score, range 0-80, higher scores are a worse outcome	Baseline Visit
Social Support	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	Baseline visit
Social Support	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	28-40 week visit
Social Support	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	4-12 weeks Postpartum
Race-Related Stress	Index of Race Related Stress-Brief Version Total Score, range 0-22, higher scores are worse outcomes	Baseline visit
Maternal Attachment (Antenatal)	Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes	Baseline visit
Maternal Attachment (Antenatal)	Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes	28-40 week visit
Maternal Attachment (Postnatal)	Maternal Postnatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes	4-12 Weeks Postpartum

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 202103142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No