Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care (EleVATE GC)
Primary Purpose
Pregnancy Related, Perinatal Depression
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EleVATE Group Care
Individual Prenatal Care
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy Related
Eligibility Criteria
Inclusion Criteria:
- English or Spanish speaking
- ≤16 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
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
Sites / Locations
- University of Missouri-Kansas City/Truman Health Centers-Kansas City
- Affinia Healthcare
- Family Care Health Centers
- CareSTL Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group Prenatal Care
Individual Prenatal Care
Arm Description
Group prenatal care model
Individual prenatal care
Outcomes
Primary Outcome Measures
Perinatal Depression
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Perinatal Depression
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Perinatal Depression
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Secondary Outcome Measures
Preterm Birth
Delivery at <37 weeks gestation
Small for Gestational Age
Birthweight <10th percentile on the Alexander growth curve
Perceived Stress
Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome
Perceived Stress
Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome
Perceived Stress
Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome
Anxiety
PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome
Anxiety
PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome
Anxiety
PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome
Post-Traumatic Stress Disorder (PTSD)
PTSD Checklist for DSM-V Total Symptom Severity Score, range 0-80, higher scores are a worse outcome
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
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
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
Race-Related Stress
Index of Race Related Stress-Brief Version Total Score, range 0-22, higher scores are worse outcomes
Maternal Attachment (Antenatal)
Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes
Maternal Attachment (Antenatal)
Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes
Maternal Attachment (Postnatal)
Maternal Postnatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes
Full Information
NCT ID
NCT04838210
First Posted
March 18, 2021
Last Updated
November 22, 2022
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04838210
Brief Title
Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
Acronym
EleVATE GC
Official Title
Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Perinatal Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group Prenatal Care
Arm Type
Experimental
Arm Description
Group prenatal care model
Arm Title
Individual Prenatal Care
Arm Type
Active Comparator
Arm Description
Individual prenatal care
Intervention Type
Behavioral
Intervention Name(s)
EleVATE Group Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual Prenatal Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perinatal Depression
Description
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Time Frame
Baseline visit
Title
Perinatal Depression
Description
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Time Frame
28-40 week visit
Title
Perinatal Depression
Description
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Time Frame
4-12 weeks Postpartum
Secondary Outcome Measure Information:
Title
Preterm Birth
Description
Delivery at <37 weeks gestation
Time Frame
Delivery
Title
Small for Gestational Age
Description
Birthweight <10th percentile on the Alexander growth curve
Time Frame
Delivery
Title
Perceived Stress
Description
Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome
Time Frame
Baseline visit
Title
Perceived Stress
Description
Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome
Time Frame
28-40 week
Title
Perceived Stress
Description
Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome
Time Frame
4-12 weeks Postpartum
Title
Anxiety
Description
PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome
Time Frame
Baseline visit
Title
Anxiety
Description
PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome
Time Frame
28-40 week visit
Title
Anxiety
Description
PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome
Time Frame
4-12 weeks Postpartum
Title
Post-Traumatic Stress Disorder (PTSD)
Description
PTSD Checklist for DSM-V Total Symptom Severity Score, range 0-80, higher scores are a worse outcome
Time Frame
Baseline Visit
Title
Social Support
Description
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
Title
Social Support
Description
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
28-40 week visit
Title
Social Support
Description
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
4-12 weeks Postpartum
Title
Race-Related Stress
Description
Index of Race Related Stress-Brief Version Total Score, range 0-22, higher scores are worse outcomes
Time Frame
Baseline visit
Title
Maternal Attachment (Antenatal)
Description
Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes
Time Frame
Baseline visit
Title
Maternal Attachment (Antenatal)
Description
Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes
Time Frame
28-40 week visit
Title
Maternal Attachment (Postnatal)
Description
Maternal Postnatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes
Time Frame
4-12 Weeks Postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Missouri-Kansas City/Truman Health Centers-Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Affinia Healthcare
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Family Care Health Centers
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63111
Country
United States
Facility Name
CareSTL Health
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
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