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

N/AActive Not RecruitingNCT04838210

Washington University School of Medicine416 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

416

Conditions

Pregnancy Related Perinatal Depression

Interventions

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 CareBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 13 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

Perinatal Depression

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

Time frame: Baseline visit

Perinatal Depression

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

Time frame: 28-40 week visit

Perinatal Depression

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

Time frame: 4-12 weeks Postpartum

Secondary Outcomes

Preterm Birth

Delivery at \<37 weeks gestation

Time frame: Delivery

Small for Gestational Age

Birthweight \<10th percentile on the Alexander growth curve

Time frame: Delivery

Perceived Stress

Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome

Time frame: Baseline visit

Perceived Stress

Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome

Time frame: 28-40 week

Perceived Stress

Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome

Time frame: 4-12 weeks Postpartum

Anxiety

PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome

Time frame: Baseline visit

Anxiety

PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome

Time frame: 28-40 week visit

Anxiety

PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome

Time frame: 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

Time frame: 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

Time frame: Baseline visit

Social Support

Time frame: 28-40 week visit

Social Support

Time frame: 4-12 weeks Postpartum

Race-Related Stress

Index of Race Related Stress-Brief Version Total Score, range 0-22, higher scores are worse outcomes

Time frame: Baseline visit

Maternal Attachment (Antenatal)

Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes

Time frame: Baseline visit

Maternal Attachment (Antenatal)

Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes

Time frame: 28-40 week visit

Maternal Attachment (Postnatal)

Maternal Postnatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes

Time frame: 4-12 Weeks Postpartum