Healthy Aging Research Program (HARP): Engage Coaching Project for Latinos
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change From Baseline in Loneliness at Post Intervention
研究概览
简要总结
This study asks: "what behavioral strategies are needed to help socially disconnected Hispanic/Latino caregivers with significant barriers to increasing connectedness?" This study uses a mixed methods approach to adapt a brief behavioral intervention-Social Engage psychotherapy-for use with socially disconnected Hispanic/Latino caregivers. This study is a single-arm clinical trial of Social Engage psychotherapy. We propose to enroll 10 participants for up to 8 weekly individual Social Engage psychotherapy sessions, over up to 3 months. Subjects will be aged 40 and older, and be caregivers for a community-dwelling family member with ADRD, living with (or in close proximity to) the family member with dementia, experiencing elevated caregiving distress and social disconnectedness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 yrs;
- •Hispanic/Latino
- •English or Spanish speaking;
- •Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
- •Endorse elevated caregiving distress as measured by a score of ≥ 11 on the 10-item Perceived Stress Scale (PSS-10) and/or a score of 5 or greater on the Modified Caregiver Strain Index (MCSI);
- •Endorse clinically significant loneliness as measured by a score of ≥ 6 on the UCLA Loneliness Scale: Short Form.
- •Has access to e-mail in order to complete the e-consent module in REDCap which will be used in this study.
排除标准
- •Primary language is not English or Spanish;
- •Recent or current psychosis;
- •Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment;
- •Hearing problems that preclude completion of the intervention.
结局指标
主要结局
Change From Baseline in Loneliness at Post Intervention
时间窗: Baseline and 3 months
The UCLA Loneliness Scale Version 3 will be used to assess self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. However, some individual items must be reverse-coded so that higher total scores reflect greater loneliness (i.e., 1=4, 2=3, 3=2, 4=1). These items (e.g., "How often do you feel there are people you can turn to?") are items 1,5,6,9,10,15,16,19,20. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness). Mean change in total scores (change = baseline intervention scores - post scores) will be reported.
次要结局
- Change From Baseline in Social Functioning at Post Intervention(Baseline and 3 months)
- Change From Baseline in Quality of Life: Social Relationships at Post Intervention(Baseline and 3 months)
研究者
Caroline Silva
Assistant Professor
University of Rochester
