Pregnancy RelatedEleVATE GCNCT04838210
Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
A study testing EleVATE Group Care and Individual Prenatal Care in people with Pregnancy Related and Perinatal Depression, run by Washington University School of Medicine at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- Pregnancy Related, Perinatal Depression
- What is being tested?
- EleVATE Group Care and Individual Prenatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 May 2021to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Missouri-Kansas City/Truman Health Centers-Kansas City
Kansas City, Missouri, 64108
Affinia Healthcare
St Louis, Missouri, 63104
Family Care Health Centers
St Louis, Missouri, 63111
CareSTL Health
St Louis, Missouri, 63112
About this study
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.
- Conditions
- Pregnancy Related, Perinatal Depression
- Being tested
- EleVATE Group Care, Individual Prenatal Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EleVATE Group CareBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Prenatal Care | Experimental | Group prenatal care model Receives: Behavioral: EleVATE Group Care |
| Individual Prenatal Care | Active comparator | Individual prenatal care Receives: Behavioral: Individual Prenatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal Depression
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Measured: Baseline visit
Perinatal Depression
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Measured: 28-40 week visit
Perinatal Depression
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Measured: 4-12 weeks Postpartum
Secondary outcomes (16)
Preterm Birth
Delivery at <37 weeks gestation
Measured: Delivery
Small for Gestational Age
Birthweight <10th percentile on the Alexander growth curve
Measured: Delivery
Perceived Stress
Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome
Measured: Baseline visit
Perceived Stress
Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome
Measured: 28-40 week
Perceived Stress
Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome
Measured: 4-12 weeks Postpartum
Anxiety
PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome
Measured: Baseline visit
Anxiety
PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome
Measured: 28-40 week visit
Anxiety
PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome
Measured: 4-12 weeks Postpartum
Post-Traumatic Stress Disorder (PTSD)
PTSD Checklist for DSM-V Total Symptom Severity Score, range 0-80, higher scores are a worse outcome
Measured: Baseline Visit
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
Measured: Baseline visit
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
Measured: 28-40 week visit
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
Measured: 4-12 weeks Postpartum
Race-Related Stress
Index of Race Related Stress-Brief Version Total Score, range 0-22, higher scores are worse outcomes
Measured: Baseline visit
Maternal Attachment (Antenatal)
Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes
Measured: Baseline visit
Maternal Attachment (Antenatal)
Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes
Measured: 28-40 week visit
Maternal Attachment (Postnatal)
Maternal Postnatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes
Measured: 4-12 Weeks Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start21 May 2021
- Primary completion3 Dec 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838210
- Sponsor's protocol ID
- 202103142
- Acronym
- EleVATE GC
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
- ClinicalTrials.gov ID
- NCT04838210
- Acronym / sponsor ID
- EleVATE GC / 202103142
- Conditions
- Pregnancy Related, Perinatal Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group Prenatal Care | Experimental | Behavioral: EleVATE Group CareGroup prenatal care model |
| Individual Prenatal Care | Active comparator | Behavioral: Individual Prenatal CareIndividual prenatal care |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EleVATE Group Care10-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. | Behavioural | Group Prenatal Care |
| Individual Prenatal CareThe 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. | Behavioural | Individual Prenatal Care |
Primary outcome
Perinatal Depression
Time frame: Baseline visit
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Perinatal Depression
Time frame: 28-40 week visit
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Perinatal Depression
Time frame: 4-12 weeks Postpartum
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
16 secondary outcomes
Preterm Birth
Time frame: Delivery
Small for Gestational Age
Time frame: Delivery
Perceived Stress
Time frame: Baseline visit
Perceived Stress
Time frame: 28-40 week
Perceived Stress
Time frame: 4-12 weeks Postpartum
Anxiety
Time frame: Baseline visit
Anxiety
Time frame: 28-40 week visit
Anxiety
Time frame: 4-12 weeks Postpartum
Post-Traumatic Stress Disorder (PTSD)
Time frame: Baseline Visit
Social Support
Time frame: Baseline visit
Social Support
Time frame: 28-40 week visit
Social Support
Time frame: 4-12 weeks Postpartum
Race-Related Stress
Time frame: Baseline visit
Maternal Attachment (Antenatal)
Time frame: Baseline visit
Maternal Attachment (Antenatal)
Time frame: 28-40 week visit
Maternal Attachment (Postnatal)
Time frame: 4-12 Weeks Postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EleVATE Group Care and Individual Prenatal Care in people with Pregnancy Related and Perinatal Depression, run by Washington University School of Medicine at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal Depression (time frame: Baseline visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.