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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

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

Study information

Verified date May 2024
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


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
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