Group Prenatal Care for Depression During Pregnancy

(EleVATE GC Trial)

Enrolling by invitation at 6 trial locations

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Multiple gestation, Major fetal anomaly, Serious medical/psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to addressing depression during pregnancy through group prenatal care, specifically using the EleVATE Group Care model. The researchers aim to determine if this model can reduce depression, early births, and low birth weights among African-American women. The study seeks participants who are less than 18 weeks pregnant, speak English or Spanish, and have certain risk factors for postpartum depression, such as a history of depression or low income. Participants will be randomly assigned to either group or individual prenatal care to evaluate which method is more effective. The goal is to develop a model that could benefit low-income women of color across the U.S. if successful. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve prenatal care for women of color nationwide.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that EleVATE Group Care is safe for prenatal use?

Research has shown that EleVATE Group Care, a group prenatal care program, is safe for participants. This program includes sessions with groups of five to ten pregnant women and is specifically designed for Black women. It focuses on providing support and tools to help manage stress and improve mental health.

Although studies have not highlighted specific safety concerns or side effects, the testing of EleVATE Group Care suggests it is generally considered safe. Typically, if a treatment were unsafe, it would not be offered in a trial. This group care model aims to support pregnant women in a positive and welcoming environment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EleVATE Group Care because it offers a fresh approach to tackling depression during pregnancy by focusing on group prenatal care. Unlike standard care, which usually involves one-on-one sessions with healthcare providers, this group model encourages shared experiences and peer support, which can be particularly uplifting for expectant mothers facing depression. This method aims to foster a sense of community and collective learning, potentially improving mental health outcomes by creating a supportive network. By shifting from traditional individual care to a group setting, EleVATE could provide not only emotional benefits but also enhance engagement and satisfaction with prenatal care.

What evidence suggests that EleVATE Group Care is effective for reducing perinatal depression?

Research shows that group prenatal care models, such as EleVATE Group Care, can improve mental health for pregnant women. Studies have found that social support during pregnancy protects against postpartum depression. EleVATE Group Care aims to build a supportive community, potentially lowering depression and stress during pregnancy. Evidence suggests this approach benefits the mental health of Black birthing people. It may also reduce health disparities and improve pregnancy outcomes, such as lowering the chances of early births and low birthweight. Early signs are promising, indicating that group care effectively supports maternal mental health. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for African-American women who are pregnant, at high risk of postpartum depression, and under 18 weeks' gestation. They must be able to give informed consent, attend group prenatal visits, speak English or Spanish, and have a history that may increase their risk of depression. Women with multiple pregnancies or serious health issues are not eligible.

Inclusion Criteria

I am less than 18 weeks pregnant.

The fetus is considered to be a fetus at ≤16 weeks' gestation

Established prenatal care at EleVATE site

Exclusion Criteria

You are carrying more than one baby at the same time.

I have a serious health condition that requires more care than a group can provide.

I have a serious health or mental condition that requires more care than a group can offer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Care

Participants receive either group or individual prenatal care to address depression, toxic stress, and equity

28-40 weeks

Regular prenatal visits

Postpartum Follow-up

Participants are monitored for perinatal depression, stress, and other outcomes postpartum

4-12 weeks

Postpartum visits

What Are the Treatments Tested in This Trial?

Interventions

• EleVATE Group Care

Trial Overview The study tests EleVATE Group Care against Individual Prenatal Care to see if it can reduce perinatal depression and improve birth outcomes in low-income African-American women. Participants will either join the group care model or receive standard individual care.

How Is the Trial Designed?

Group I: Group Prenatal Care Experimental Treatment 1 Intervention

Group prenatal care model

Group II: Individual Prenatal Care Active Control 1 Intervention

Individual prenatal care

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10823176/

Elevating Voices, Addressing Depression, Toxic Stress ... EleVATE is a group prenatal care (GC) model designed to improve pregnancy outcomes and promote health equity for Black birthing people.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33358645/

The contribution of group prenatal care to maternal ... The evidence suggests improvements in some markers of psychological health outcomes with group pregnancy care.

4. womensmentalhealth.org womensmentalhealth.org/posts/maternal-depression-2/

Can Group Prenatal Care Support Maternal Mental Health? The importance of social support for mental health is well documented, and it has been identified as a protective factor for postpartum depression and has other ...

5. withpower.com withpower.com/trial/phase-depressive-disorder-4-2021-a7535

Group Prenatal Care for Depression During Pregnancy · ... The EleVATE GC medical study, being run by Washington University School of Medicine, needs participants to evaluate whether EleVATE Group Care will have ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38287981/

Elevating Voices, Addressing Depression, Toxic Stress, ... Patients participating in group prenatal care (EleVATE GC or CP) were significantly less likely to experience a preterm birth <34 weeks. Rates ...

7. profiles.wustl.edu profiles.wustl.edu/en/publications/elevating-voices-addressing-depression-toxic-stress-and-equity-th

Elevating Voices, Addressing Depression, Toxic Stress ... Patients participating in group prenatal care (EleVATE GC or CP) were significantly less likely to experience a preterm birth < 34 weeks. Rates ...

8. stlouisihn.org stlouisihn.org/our-work/community-driven-innovation/perinatal-initiatives/

Perinatal Initiatives EleVATE's group prenatal care model helps equip patients with the information, support, and behavioral health tools they need to better manage trauma and stress ...

9. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2022.00798

Patients Lift Their Voices To Advance Maternal Health EleVATE offers group-based prenatal care with a curriculum designed by and for Black women. Groups of five to ten pregnant women and their ...