Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER): Testing the Efficacy of an Intervention to Prevent Psychological Elder Abuse in Family Caregiving
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Psychological Elder Abuse
研究概览
简要总结
The Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER) intervention was developed to prevent psychological elder abuse (EA) and promote high-quality caregiving by lowering relationship strain and developing CG resourcefulness. The goal of this two-arm, randomized control trial is to determine the efficacy of KINDER at mitigating psychological EA by family caregivers to persons living with dementia and to describe how the intervention may work to reduce psychological EA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range: from 18 to No upper limit;
- •Be a family member to an individual living with AD/ADRD;
- •Provide assistance with at least two instrumental activities of daily living or one activity of daily living;
- •Provides at least 4 hours of caregiving per day and sees the care recipient in-person at least 2 times per week on average
- •The care recipient is at least age 65 or older
- •Report an AD8 Dementia Screening score for care recipients of at least 2;
- •Commit to attending at three discussion sessions;
- •Have reliable access to internet and email, and to be able to attend synchronous sessions using the Zoom videoconferencing platform.
- •Caregiver lives in any of the following states, which may require mandetory reporting of elder mistreatment when responding to survey questions:
- •Delaware, Florida, Indiana, Kentucky, Louisiana, Mississippi, Montana, New Hampshire, New Mexico, North Carolina, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Utah, Wyoming
排除标准
- •Are unable to read or speak English;
- •Previously participated in Learning Skills Together (NCT05846984) or KINDER pilot study;
- •Have plans to place the care recipient in a skilled nursing facility within the next 8 months (i.e., study duration)
研究组 & 干预措施
Control Condition
Caregivers in the control arm will receive a workbook that covers 8 weeks of content focused on healthy living (e.g., nutrition).
干预措施: Healthy Living for the Caregiver (Behavioral)
KINDER Intervention Arm
KINDER is an 8-week intervention that consists of three facilitated group discussion sessions conducted over Zoom with a small group of caregivers, in addition to self-paced lessons delivered using a printed or PDF workbook, depending on participant preference. Throughout KINDER, caregivers reflect on their relationship, including how their behavior toward the care recipient may need to change considering new vulnerabilities with dementia, and how to communicate about topics that often contribute to conflict, such as balancing safety and independence (e.g., driving).
干预措施: Knowledge and Interpersonal Skills to Develop Enhanced Relationships (Behavioral)
结局指标
主要结局
Psychological Elder Abuse
时间窗: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
The investigators will use a modified version of the Conflict Tactics Scale 2 to measure psychological EA (MCTS 2). This scale includes five psychological EA behaviors, such as insulting, swearing at, or yelling at the care recipient, as well as threatening to stop taking care of the care recipient, placing them in a nursing home, threatening physical harm, and stomping out of the room. Participants will be asked to describe the frequency of each behavior in the last 2 months, such that response options will include: None, Once, Twice, 3 to 5 times, 6 to 10 times, and More than 10 times. Scores range from 0 to 30. Higher scores indicate greater frequency of mistreatment. Higher scores indicate greater frequency of abuse. The outcome measure will use the average change score from baseline scores until each post-intervention survey.
Quality of Caregiving
时间窗: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
To measure quality of care, the investigators will use the 11-item Exemplary Caregiving Scale, which focuses on providing care that meets the care recipient's needs (α=0.73) and is respectful (α=0.76). Response options include Never, Sometimes, Often, and Always (range: 11 to 44). Higher scores indicate higher quality of caregiving. The outcome measure will use the average change score from baseline scores until each post-intervention survey.
次要结局
- Resourcefulness(Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention)
- Caregiving Relationship Strain(Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention)
研究者
Kylie Meyer
Principal Investigator
Case Western Reserve University