Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 874
- 试验地点
- 2
- 主要终点
- The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum
研究概览
简要总结
There is considerable evidence that most perinatal women at risk for postpartum depression do not engage in mental health services, even when referred by home visiting (HV) programs, primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be delivered via alternative settings-e.g., HV programs-are essential to prevent the onset of major depression and worsening of depressive symptoms among perinatal women. This Patient Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is more efficacious than usual care (i.e., home visiting without the MB enhancement). It will also examine if MB, when led by paraprofessional home visitors, is not inferior to MB delivered by mental health professionals. The results of this study will inform decision-making by HV programs regarding provision of MB to perinatal women at risk for developing major depression.
详细描述
Study Aims:
Aim #1 is to conduct a superiority trial that compares the efficacy of MB delivered by paraprofessional home visitors versus usual care (i.e., home visiting without MB) on patient-reported outcomes, including depressive symptoms, quality of life, parenting practices, engagement in pleasant activities, and relationship with one's partner.
Aim #2 is to conduct a non-inferiority trial that compares the effectiveness of MB delivered by (a) mental health clinicians versus (b) paraprofessional home visitors.
Aim #3 is to evaluate whether effectiveness of the two versions of MB (clinician led vs. paraprofessional home visitor led) varies according to patient characteristics (e.g., race, ethnicity, first-time mother, and/or geographic type of home visiting (HV) program (i.e., urban vs. rural).
Aim #4 is to examine the feasibility and acceptability of MB delivered by paraprofessional home visitors and mental health clinicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The investigators will enroll only pregnant women in this study, given that the Mothers and Babies Course is delivered prenatally as a postpartum depression prevention intervention. The investigators will offer participation to prenatal home visiting clients, ages 16 and older, knowing the client base for home visiting programs includes pregnant teens.
排除标准
- •Women with high-risk medical and pregnancy conditions will be excluded since this may preclude women from regularly attending intervention sessions. The investigators will not exclude women based on race/ethnicity or based on demographic characteristics other than the ability to speak English or Spanish.
结局指标
主要结局
The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum
时间窗: Baseline and 12 and 24-week postpartum follow-up
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16). The QIDS-SR16 was used to assess severity of depressive symptoms consistent with Diagnostic and Statistical Manual symptom criteria. Total scores range from 0-27; higher scores indicate greater symptomatology. The investigators anticipate a clinically meaningfully difference to be on the order of five points (as this is the difference in score on each severity level of depression) (Trivedi et al., 2004). For our non-inferiority analyses comparing MB led by home visitors vs. MB led by mental health clinicians, we will have \>85% power to detect a difference difference in mean QIDS-16 scores of two points between the two active intervention arms.
次要结局
- The Change in the Behavioral Activation Scale From Baseline to 24-weeks Postpartum(Baseline and 12 and 24-week postpartum follow-ups)
- The Change in the Experiences Questionnaire From Baseline to 24-Weeks Postpartum(Baseline and 12 and 24-week follow-ups)
- The Change in the MOS Social Support Survey From Baseline to 24-Weeks Postpartum(Baseline and 12 and 24-week follow-ups)
- The Change in the Negative Mood Regulation Scale(Baseline and 12 and 24-week postpartum follow-ups)
研究者
Darius Tandon
Associate Professor
Northwestern University