Parents and Babies: Pilot Testing an Inclusive Preventive Postpartum Depression Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire - 9 (PHQ-9)
研究概览
简要总结
The goal of this study will be piloting the Parents and Babies perinatal depression prevention intervention to examine its feasibility and acceptability and to obtain preliminary data on its efficacy. This includes exploring/understanding users' experiences navigating the interventions (e.g., from an implementation perspective) and preliminary evaluations of clinical outcomes, including mental health and minority stress. With data gathered from this pilot study, we will make final adaptations to the Parents and Babies manuals and plan to develop a randomized-control trial to evaluate efficacy of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •self-identify as LGBTQ+
- •18 years old or older
- •live in the USA or territories
- •speak and understand English
- •Currently pregnant or within one year of childbirth
- •Endorse current mild depressive symptoms or risk factors for postpartum depression
排除标准
- •Are unable to consent/have impaired decision making capacity
- •Have current active suicidal or homicidal ideation, active psychosis, or current mania
- •Are currently experiencing a severe depressive episode
- •Do not have audio and/or video capacity for attending group sessions remotely.
研究组 & 干预措施
Hybrid Group
Sessions will be delivered virtually with three hybrid sessions with options for in-person attendance. Includes only participants located in the Chicagoland area.
干预措施: Parents and Babies Hybrid Group Intervention (Behavioral)
Virtual Group
Sessions will be delivered virtually. Includes participants from across the US.
干预措施: Parents and Babies Virtual Group Intervention (Behavioral)
结局指标
主要结局
Patient Health Questionnaire - 9 (PHQ-9)
时间窗: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
The Patient Health Questionnaire-9 is the 9 item depression module of the Patient Health Questionnaire. It scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Higher scores indicate an increased severity of depression symptoms.
Perceived Stress Scale (PSS-10)
时间窗: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
The Perceived Stress Scale (PSS-10; Cohen, Kamarch, \& Mermelstein,1983) is a 10 item measure of the degree to which situations in one's life are appraised as stressful with responses rated on a 5-point Likert scale (0 =never to 4 =very often). Higher scores indicate greater perceived stress.
Generalized Anxiety Disorder Scale (GAD-7)
时间窗: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
The Generalized Anxiety Disorder Scale (Spitzer et.al, 2006) is a 7 item self-report measure used to assess anxiety. Participants are queried regarding symptoms during the past two weeks and responses are tallied on a four-point Likert scale. (0 = not at all to 3=nearly every day.) Higher scores indicate an increased severity of anxiety symptoms.
Multidimensional Scale of Perceived Social Support (MSPSS)
时间窗: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
The Multidimensional Scale of Perceived Social Support (Zimet et al. 1988) is a 12-item measure of perceived adequacy of social support from three sources: family, friends, \& significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree). Higher scores in each subscale indicate greater perceived support from that source.
The Acceptability of Intervention Measure (AIM)
时间窗: T2 (immediately post-intervention)
The Acceptability of Intervention Measure (Weiner et al., 2017) is a four-item measure of implementation outcomes to determine the extent to which one believes an intervention is appealing and satisfactory on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Higher scores indicate greater perceived acceptability of the intervention.
Intervention Appropriateness Measure (IAM)
时间窗: T2 (immediately post-intervention)
Intervention Appropriateness Measure (Weiner et al., 2017) is a four-item measure evaluating the extent to which one believes an intervention is suitable, relevant, compatible, and applicable to one's needs on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Higher scores indicate greater perceived appropriateness of the intervention.
Feasibility of Intervention Measure (FIM)
时间窗: T2 (immediately post-intervention)
Feasibility of Intervention Measure (Weiner et al., 2017) is a four-item survey measuring the perceived feasibility of an intervention on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Higher scores indicate greater perceived feasibility of the intervention.
Implementation of Parents and Babies skills
时间窗: T2 (immediately post-intervention), T3 (3-months post-intervention)
Parents and Babies Skill Utilization Survey - 8 item questionnaire to determine the extent to which one agrees that the PAB course taught skills related to the core modules, was useful, and was easy to understand; using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).
次要结局
未报告次要终点
研究者
Leiszle Rae Lapping-Carr
Principal Investigator
Northwestern University