A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care (MInD)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline in Perinatal Depression Symptomology on the Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention.
详细描述
Eligible and consenting participants will be randomized in a single blind manner (research visitor will be blinded to condition) at a 1:1 ratio to either MInD (parenting intervention and usual perinatal collaborative care) or usual collaborative care in their second trimester of pregnancy. Research assessments will be administered during pregnancy and post-partum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking pregnant women between gestational age (GA) 13 - 24 weeks
- •≥ 18 years,
- •EPDS score ≥10,
- •Ability to send and receive text messages (TM)
排除标准
- •Severe substance use disorder in the past 6 months (score of 4 or above on the Alcohol Use Disorders Test AUDIT-C or a score of 6 or more on the Drug Abuse Screening Test (DAST).
- •Active suicidal ideation as measured by follow up to a positive answer to question 10 on the EPDS.
- •Bipolar disorder (Composite International Diagnostic Interview score ≥7) or psychotic disorder (assessed by chart review);
- •Multiple gestation (assessed by self-report and medical record);
- •Ongoing active treatment with psychotropic medications by mental health specialist (but not a PCP or Obstetrician).
结局指标
主要结局
Change from Baseline in Perinatal Depression Symptomology on the Edinburgh Postnatal Depression Scale (EPDS)
时间窗: Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
The EPDS is a ten-item self-report depression measure with higher scores indicating increased symptoms severity, total score ranging from 0 to 30 and is validated for use in the perinatal period.
次要结局
- Change from Baseline in Disability on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)(Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum)
- Change from Baseline in Parental Self-Efficacy on the Self-Efficacy in a Nurturing Role (SENR)(Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum)
- Relative utilization of MInD vs usual CC(Baseline through up to 6 Months Postpartum (up to maximum of 9 months))
- Perceived match of treatment to patient need using Working Alliance Inventory (WAI-SR)(30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum)
- Change from Postpartum Baseline in Dyadic Interaction(6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum)
- Change from Postpartum Baseline in Maternal Functioning on the Barkin Index of Maternal Functioning (BIMF)(6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum)
研究者
Amritha Subray Bhat
Assistant Professor, School of Medicine: Psychiatry
University of Washington