Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 416
- 试验地点
- 5
- 主要终点
- Perinatal Depression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group Prenatal Care
Group prenatal care model
干预措施: EleVATE Group Care (Behavioral)
Individual Prenatal Care
Individual prenatal care
干预措施: Individual Prenatal Care (Behavioral)
结局指标
主要结局
Perinatal Depression
时间窗: 4-12 weeks Postpartum
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Perinatal Depression
时间窗: Baseline visit
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
Perinatal Depression
时间窗: 28-40 week visit
Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome)
次要结局
- Preterm Birth(Delivery)
- Anxiety(4-12 weeks Postpartum)
- Social Support(4-12 weeks Postpartum)
- Small for Gestational Age(Delivery)
- Perceived Stress(4-12 weeks Postpartum)
- Post-Traumatic Stress Disorder (PTSD)(Baseline Visit)
- Race-Related Stress(Baseline visit)
- Maternal Attachment (Postnatal)(4-12 Weeks Postpartum)
- Maternal Attachment (Antenatal)(28-40 week visit)
- Perceived Stress(Baseline visit)
- Perceived Stress(28-40 week)
- Anxiety(Baseline visit)
- Anxiety(28-40 week visit)
- Social Support(Baseline visit)
- Social Support(28-40 week visit)
- Maternal Attachment (Antenatal)(Baseline visit)