Perinatal Depression, Pregnancy Related
Conditions
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.
Interventions
BEHAVIORALIndividual 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.
BEHAVIORALEleVATE 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.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
13 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perinatal Depression | Baseline visit | Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preterm Birth | Delivery | Delivery at \<37 weeks gestation |
| Small for Gestational Age | Delivery | Birthweight \<10th percentile on the Alexander growth curve |
| Perceived Stress | Baseline visit | Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome |
| Anxiety | Baseline visit | PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome |
| Post-Traumatic Stress Disorder (PTSD) | Baseline Visit | PTSD Checklist for DSM-V Total Symptom Severity Score, range 0-80, higher scores are a worse outcome |
| Social Support | 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 |
| Race-Related Stress | Baseline visit | Index of Race Related Stress-Brief Version Total Score, range 0-22, higher scores are worse outcomes |
| Maternal Attachment (Antenatal) | Baseline visit | Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes |
| Maternal Attachment (Postnatal) | 4-12 Weeks Postpartum | Maternal Postnatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes |
Countries
United States
Outcome results
None listed