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

Pregnancy Related Clinical Trial

— EleVATE GC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04838210
• Other study ID #: 202103142
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 390
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Perinatal Depression
• Pregnancy Related

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Missouri-Kansas City/Truman Health Centers-Kansas City	Kansas City	Missouri
United States	Affinia Healthcare	Saint Louis	Missouri
United States	CareSTL Health	Saint Louis	Missouri
United States	Family Care Health Centers	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perinatal Depression	Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)	Baseline visit
Primary	Perinatal Depression	Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)	28-40 week visit
Primary	Perinatal Depression	Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)	4-12 weeks Postpartum
Secondary	Preterm Birth	Delivery at <37 weeks gestation	Delivery
Secondary	Small for Gestational Age	Birthweight <10th percentile on the Alexander growth curve	Delivery
Secondary	Perceived Stress	Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome	Baseline visit
Secondary	Perceived Stress	Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome	28-40 week
Secondary	Perceived Stress	Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome	4-12 weeks Postpartum
Secondary	Anxiety	PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome	Baseline visit
Secondary	Anxiety	PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome	28-40 week visit
Secondary	Anxiety	PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome	4-12 weeks Postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Race-Related Stress	Index of Race Related Stress-Brief Version Total Score, range 0-22, higher scores are worse outcomes	Baseline visit
Secondary	Maternal Attachment (Antenatal)	Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes	Baseline visit
Secondary	Maternal Attachment (Antenatal)	Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes	28-40 week visit
Secondary	Maternal Attachment (Postnatal)	Maternal Postnatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes	4-12 Weeks Postpartum