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NCT Number: NCT04838210

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pregnancy Related Perinatal Depression

Age range

13 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri-Kansas City/Truman Health Centers-Kansas City, Kansas City, Missouri, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EleVATE Group Care

Behavioral

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

Behavioral

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 outcomes

  1. Perinatal Depression

    Time frame: Baseline visit

    Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)

  2. Perinatal Depression

    Time frame: 28-40 week visit

    Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)

  3. Perinatal Depression

    Time frame: 4-12 weeks Postpartum

    Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)

Secondary outcomes

  1. Preterm Birth

    Time frame: Delivery

    Delivery at <37 weeks gestation

  2. Small for Gestational Age

    Time frame: Delivery

    Birthweight <10th percentile on the Alexander growth curve

  3. Perceived Stress

    Time frame: Baseline visit

    Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome

  4. Perceived Stress

    Time frame: 28-40 week

    Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome

  5. Perceived Stress

    Time frame: 4-12 weeks Postpartum

    Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome

  6. Anxiety

    Time frame: Baseline visit

    PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome

  7. Anxiety

    Time frame: 28-40 week visit

    PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome

  8. Anxiety

    Time frame: 4-12 weeks Postpartum

    PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome

  9. Post-Traumatic Stress Disorder (PTSD)

    Time frame: Baseline Visit

    PTSD Checklist for DSM-V Total Symptom Severity Score, range 0-80, higher scores are a worse outcome

  10. Social Support

    Time frame: Baseline visit

    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

  11. Social Support

    Time frame: 28-40 week visit

    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

  12. Social Support

    Time frame: 4-12 weeks Postpartum

    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

  13. Race-Related Stress

    Time frame: Baseline visit

    Index of Race Related Stress-Brief Version Total Score, range 0-22, higher scores are worse outcomes

  14. Maternal Attachment (Antenatal)

    Time frame: Baseline visit

    Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes

  15. Maternal Attachment (Antenatal)

    Time frame: 28-40 week visit

    Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes

  16. Maternal Attachment (Postnatal)

    Time frame: 4-12 Weeks Postpartum

    Maternal Postnatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: EleVATE GC

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 9, 2021
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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