Developing and Piloting a Tailored Self-Compassion Program to Enhance the Well-Being of Informal Caregivers of Children With Physical Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Percentage of participants who withdraw from course
研究概览
简要总结
The goal of this clinical trial is to test the feasibility, acceptability and preliminary social/emotional well-being outcomes of a tailored, online self-compassion-based resilience course for caregivers of children with physical disabilities. The main questions it aims to answer are:
- Is the online resilience course feasible and acceptable to caregivers of children with physical disabilities?
- Is participation in the resilience course associated with improvements in caregiver stress, anxiety, depression, burden, caregiver uplifts, self-compassion, emotion regulation and/or resilience?
Participants will complete a screening, a verbal consent process and an electronic pre-course survey. Then, they will participate in a 6-session weekly online course with other caregivers and led by a certified Mindful Self-Compassion instructor. The course has been created with feedback from caregivers and includes skills for recognizing and coping with difficult emotions while connecting with others who have similar caregiving experiences. After the course, participants will repeat the electronic survey and will provide feedback on the course during a live, online feedback session.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Caregiver is at least 18 years old
- •Caregiver reads and speaks in English
- •Caregiver is a primary caregiver to a child aged 2-17 with a moderate to severe chronic physical disability (child requires assistance or adapted methods for mobility (e.g., walking, transfers) and at least 1 other functional area (e.g., toileting, feeding, communication))
排除标准
- •Caregiver has no access to the internet/Zoom
- •Caregiver has been hospitalized in the last year for mental health treatment
- •Caregiver has a history of psychosis (e.g., schizophrenia)
- •Caregiver will miss 2 or more class sessions due to scheduling conflicts
结局指标
主要结局
Percentage of participants who withdraw from course
时间窗: Across 6 weeks of intervention
The study records will indicate withdrawal status (Yes or No) for each enrolled participant who has attended at least 1 intervention session; Calculated by: number who withdraw/total number enrolled X 100
Percentage of participants who attend at least 4 of 6 intervention sessions
时间窗: Across 6 weeks of intervention
The study records will indicate weekly attendance at each session (Yes or No) for each enrolled participant who has attended at least 1 intervention session. Calculated by: number who attend at least 4 of 6 sessions/total number enrolled X 100
Percentage of participants who rate the course as "acceptable" or "completely acceptable"
时间窗: 6 weeks
The Theoretical Framework of Acceptability includes 7-items regarding intervention acceptability on a scale of 1 to 5, scores range 7-35, higher numbers indicate greater acceptability. This general acceptability item will be used to assess overall acceptability of the course. Calculated by: number of participants who endorse "acceptable" or "completely acceptable"/total number of respondents X 100
Percentage of intervention topics covered
时间窗: Across 6 weeks of intervention
A research assistant in attendance will use a fidelity checklist to assess if intended topics are covered each session (Yes/No). Calculated by number of topics covered/total number of topics intended to be covered X 100
次要结局
- Mean Change in Resilience as measured by the Connor-Davidson Resilience Scale-10 at 6 weeks(Baseline and 6 weeks)
- Mean Change in Anxiety as measured by the PROMIS-SF 7-item Anxiety Scale at 6 weeks(Baseline and 6 weeks)
- Mean Change in Depressive symptoms as measured by the PROMIS-SF 8-item Depression Scale at 6 weeks(Baseline and 6 weeks)
- Mean Change in Self-Compassion as measured by the Self-Compassion Scale-Short form (SCS-SF) at 6 weeks(Baseline and 6 weeks)
- Mean Change in Caregiver Uplifts as measured by the Uplifts subscale of the Revised Burden Measure at 6 weeks(Baseline and 6 weeks)
- Mean Change in Difficulties with Emotion Regulation as measured by the Difficulties in Emotion Regulation-Short Form Scale(Baseline and 6 weeks)
- Mean Change in Perceived Stress as Measured by the Perceived Stress Scale (PSS-10 item) at 6 weeks(Baseline and 6 weeks)
- Mean Change in Caregiver Burden as measured by the 12-item Zarit Caregiver Burden Scale (ZBI-12) at 6 weeks(Baseline and 6 weeks)