Hope as a Path to Healing: Developing a Single-Session Intervention for Women Who Experience Intimate Partner Violence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Acceptability/likability assessed using the Program Feeback Scale
研究概览
简要总结
The purpose of this study is to develop a brief, self-guided single-session intervention (SSI) that targets the development of, or increase in, hope, and pilot test it for the primary outcomes of feasibility, acceptability/likeability, safety, and changes in hope, and the secondary outcomes of self-worth, empowerment, and emotional wellbeing among women experiencing intimate partner violence (IPV). The study will be conducted in 2 stages: intervention development (Intervention Development Stage), and pilot testing the intervention (Pilot Stage). The focus of this registration is the Pilot Stage.
详细描述
This study aims to accomplish two primary objectives: Objective 1 (Intervention Development Stage): Develop a brief, self-guided SSI to enhance hope and in turn, self-worth, empowerment, and emotional wellbeing, and Objective 2 (Pilot Stage): Pilot test the intervention and evaluate the process of implementation and primary outcomes of feasibility, acceptability/likability, and safety; and to assess changes in hope and secondary outcomes of self-worth, empowerment, and emotional wellbeing.
The Pilot Stage will utilize micro-longitudinal methods (i.e., daily self-reports of hope, self-worth, empowerment, and emotional wellbeing for 14 days before and after the intervention) to assess changes in these constructs. Eligible participants will take part in a baseline interview with a member of the research team. Baseline measures will be based on participant self-report and used to characterize the sample and collect data on person-level control variables. Beginning the day after the baseline interview, participants will complete a brief daily survey on their smartphone. On day 15, participants will receive a link to the SSI and be asked to complete it that day; immediately following the SSI, participants will be asked to complete the post-intervention survey/process supplement to aid in the process evaluation. After completion of the SSI, survivors will participate in 14 additional days of daily data collection to establish post-intervention outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Pilot Stage:
- •Self-identify as a woman (cis- or trans-gender woman)
- •Currently in a relationship of at least 3 months duration in which they have experienced physical IPV by a male partner
- •Have a smartphone that is compatible with the MyCap app to be able to participate in daily surveys.
排除标准
- •Pilot Stage:
- •Have experienced significant psychiatric instability based on self-reported inpatient psychiatric hospitalization in the past 3 months
- •Reports having a conservator of person
- •Not comfortable conversing, reading, or writing in English
- •Participated in a Listening Session in the development phase of this study.
结局指标
主要结局
Acceptability/likability assessed using the Program Feeback Scale
时间窗: up to one month
The Program Feedback Scale asks participant to rate seven statements regarding intervention acceptability and feasibility; it also includes open-response items that invite participants to share what they liked and/or would change about the intervention. The seven statements are rated from 0 (Strongly Disagree) to 5 (Strongly Agree). Total scores range from 0 to 36, with higher scores indicating a more positive evaluation.
Safety assessed using end of study survey
时间窗: up to one month
Participants will be asked if completing the intervention caused any problems for them and their partner that made them feel unsafe; participants responding in the affirmative will be asked to elaborate in a follow-up open-response question.
Change in Hope assessed using Trait Hope Scale
时间窗: baseline (pre intervention) and up to one month (post intervention)
Change in hope will be assessed with daily data using 2 items from the Trait Hope Scale; 1 item from the agency subscale and 1 item from the pathway subscale. Items are rated from 0 (Strongly Disagree) to 5 (Strongly Agree), with higher values indicating more hope
Feasibility assessed by percent enrolled
时间窗: up to one month
The percent of women enrolled in the study who complete the SSI and individual SSI components.
Feasibility assessed by post-intervention survey/process supplement
时间窗: up to one month
Feasibility will also be assessed in the post-intervention survey/process supplement by asking women 1) where they completed the program, 2) if they listened to the program's read aloud options, and 3) an open-response question about factors that influenced where and when they completed the program since little is known about factors that participation in an intervention of this nature.
Change in Hope assessed using Beck Hopelessness Scale (single item)
时间窗: baseline (pre intervention) and up to one month (post intervention)
Hopelessness will be assessed with daily data using 1 item from the Beck Hopelessness Scale. The item is rated on a scale from 0 'Strongly disagree' to 5 'Strongly agree' with higher values indicating higher levels of hopelessness.
Change in Hope assessed using Herth Hope Index
时间窗: baseline (pre intervention) and up to one month (post intervention)
Change in hope will be assessed with daily data using 5 items from the HHI that measure 3 dimensions of hope: 2 items from the temporality and future/cognitive-temporal subscale, 1 item from the positive readiness and expectancy subscale, and 2 items from the interconnectedness subscale. Items are rated from 0 (Strongly Disagree) to 5 (Strongly Agree) with higher values indicating more hope
Feasibility assessed by time to complete
时间窗: up to one month
How long it took a participant to complete the intervention (in minutes), and if it was done in more than one setting.
次要结局
- Change in Empowerment assessed using The Personal Progress Scale-Revised (PPS-R)(baseline (pre intervention) and up to one month (post intervention))
- Change in Emotional wellbeing measured by the Patient Health Questionnaire-2 (PHQ-2)(baseline (pre intervention) and up to one month (post intervention))
- Change in Emotional wellbeing measured by the State Joy Scale(baseline (pre intervention) and up to one month (post intervention))
- Change in Self-worth(baseline (pre intervention) and up to one month (post intervention))