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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy Related, Perinatal Depression

Intervention / Treatment
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* Behavioral: EleVATE Group Care
* Behavioral: Individual Prenatal Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Prenatal Care<br>Group prenatal care model | Behavioral: EleVATE Group Care<br>* 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.<br>|
| Active Comparator: Individual Prenatal Care<br>Individual prenatal care | Behavioral: Individual Prenatal Care<br>* 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.<br>|

What is the study measuring?
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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 |