Clinical trial NCT04838210: Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
Official title: Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy Related
Perinatal Depression
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 390
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Perinatal Depression
timeFrame: Baseline visit
measure: Perinatal Depression
timeFrame: 28-40 week visit
measure: Perinatal Depression
timeFrame: 4-12 weeks Postpartum
Secondary outcomes:
measure: Preterm Birth
timeFrame: Delivery
measure: Small for Gestational Age
timeFrame: Delivery
measure: Perceived Stress
timeFrame: Baseline visit
measure: Perceived Stress
timeFrame: 28-40 week
measure: Perceived Stress
timeFrame: 4-12 weeks Postpartum
measure: Anxiety
timeFrame: Baseline visit
measure: Anxiety
timeFrame: 28-40 week visit
measure: Anxiety
timeFrame: 4-12 weeks Postpartum
measure: Post-Traumatic Stress Disorder (PTSD)
timeFrame: Baseline Visit
measure: Social Support
timeFrame: Baseline visit
measure: Social Support
timeFrame: 28-40 week visit
measure: Social Support
timeFrame: 4-12 weeks Postpartum
measure: Race-Related Stress
timeFrame: Baseline visit
measure: Maternal Attachment (Antenatal)
timeFrame: Baseline visit
measure: Maternal Attachment (Antenatal)
timeFrame: 28-40 week visit
measure: Maternal Attachment (Postnatal)
timeFrame: 4-12 Weeks Postpartum
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Missouri-Kansas City/Truman Health Centers-Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Affinia Healthcare
state: Missouri
city: Saint Louis
country: United States
facility: Family Care Health Centers
state: Missouri
city: Saint Louis
country: United States
facility: CareSTL Health
state: Missouri
Study officials:
References: