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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Prenatal Care | Experimental | Group prenatal care model |
|
| Individual Prenatal Care | Active Comparator | Individual prenatal care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm Birth | Delivery at <37 weeks gestation | Delivery |
| Small for Gestational Age | Birthweight <10th percentile on the Alexander growth curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Kansas City/Truman Health Centers-Kansas City | Kansas City | Missouri | 64108 | United States | ||
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Randomized controlled trial
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| 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. |
|
| 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 |
| Affinia Healthcare |
| St Louis |
| Missouri |
| 63104 |
| United States |
| Family Care Health Centers | St Louis | Missouri | 63111 | United States |
| CareSTL Health | St Louis | Missouri | 63112 | United States |