Advancing Perinatal Mental Health and Well-Being: The DC Mother-Infant Behavioral Wellness Program
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Change in Stress at 24 weeks of pregnancy to 12 months postpartum
研究概览
简要总结
This randomized controlled study will examine the effectiveness of patient navigation with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black/of African Descent pregnant women who are experiencing stress, anxiety, and/or depression.
详细描述
The overarching objective is to develop and evaluate a collaborative, multi-dimensional and culturally tailored community-based model of integrated perinatal MH care. The target population is low-income Black/of African descent women with pregnancy-related stress, anxiety, and depression. There are two specific aims: (1) to refine an individualized plan to integrate patient navigation and a culturally adapted cognitive-behavioral (CBT) intervention for low-income Black/of African Descent women designed to increase recruitment and retention within the healthcare community system, and (2) through a two-arm prospective randomized controlled design, women who are subthreshold and threshold risk for prenatal stress, depression and/or anxiety will participate in one of two interventions: (a) existing prenatal intervention (usual care); or (b) patient navigation plus culturally adapted CBT, and peer support groups.
The investigators will screen 1,000 low-income pregnant AA women (18-45 years of age) in their second pregnancy visit with validated tools for stress, anxiety, and depression. A total of 700 study participants will be recruited from urban prenatal care centers in the Washington DC area and will be randomized Usual Care of Intervention conditions above (n=350/condition). Following randomization, participants will participate in a diagnostic interview based on DSM-5 criteria to 'self-select' themselves into 1 of 2 groups (i.e., 'threshold' or 'subthreshold'). Threshold includes women who meet criteria for depression or anxiety based on DSM-5 diagnostic criteria. Subthreshold includes all other women who do not meet DSM criteria). In the intervention arm, participants in the threshold group will receive a 1:1 CBT treatment intervention, and participants in the subthreshold group will receive a group CBT intervention. Both threshold groups will also include patient navigation and participation in a peer support group. Participants will complete standardized health, mental health, and well-being questionnaires during pregnancy at their prenatal site, and up to 12 months after delivery at their well-baby visits, when they also will complete questionnaires about their infants' development and behavior. All infants also will undergo a standardized developmental test at 12 months. Health care utilization and outcomes also will be collected through electronic medical records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Black/of African Descent
- •Pregnant (gestational weeks ≤ 28 weeks)
- •Age 18-45
- •English proficient
- •Receiving services in 1 of 4 study sites above
- •Low-income: i.e., receiving Medicaid
- •Subthreshold or threshold risk for maternal distress (stress, depression, and/or anxiety)
- •Able to provide consent
排除标准
- •Currently under the influence of a substance(s)
- •Experiencing psychosis
- •Critical (clinical) risk: actively suicidal or homicidal
- •Not Black/of African Descent
- •Planning to deliver outside DC
结局指标
主要结局
Change in Stress at 24 weeks of pregnancy to 12 months postpartum
时间窗: Stress will be measured at 24 weeks of pregnancy through infant age of 12 months
Perceived Stress Scale: A 10-item questionnaire to measure the self-reported level of stress in the respondents by assessing feelings and thoughts during the last month. Each item is scored from 0 (never) to 5 (very often) with a range of 0 to 40 for the total score of the scale. A higher level of stress is indicated by higher scores on this scale.
Change in Depression at 24 weeks of pregnancy to 12 months postpartum
时间窗: 2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum
Edinburgh Postnatal Depression Scale: A 10-item scale used to indicate whether a parent has symptoms that are common in women with depression during pregnancy and in the year following the birth of a child. Each item is scored from 0 (As much as I ever did) to 3 (Not at all) with a range of 0 to 30. Higher level of depression is indicated by a higher score on this scale.
Change in Anxiety at 24 weeks of pregnancy to 12 months postpartum
时间窗: 2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum
General Anxiety Disorder-7 (GAD-7): A 7-item scale to measure levels of anxiety in respondents by assessing feelings and thoughts over the past 2 weeks. Each item is scored from 0 (Not at all) to 3 (Nearly every day) with a range of 0 to 21. Higher level of depression is indicated by a higher score on this scale.
次要结局
未报告次要终点
研究者
Catherine Limperopoulos
Director of the Developing Brain Institute and Director of the Advanced Pediatric Brain Imaging Research Program
Children's National Research Institute
