Effects of a Mindfulness-based Intervention on Stress, Mental Health, and Sleep Among Informal Caregivers of Children With Special Educational Needs
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Change in stress level
研究概览
简要总结
The goal of this single-arm pilot clinical trial is to evaluate whether a group-based mindfulness intervention can improve mental health and sleep among parents who are informal caregivers of children with autism spectrum disorder (ASD) or attention-deficit/hyperactivity disorder (ADHD). The main questions it aims to answer are:
Does participating in an 8-week mindfulness program reduce symptoms of stress, anxiety, depression, and insomnia in caregivers? Does participating in an 8-week mindfulness program improve mindfulness in caregivers? What are the caregivers' experiences in participating in the 8-week mindfulness program?
Participants will:
- Attend weekly group-based mindfulness sessions for 1.5 hours over eight weeks.
- Complete assessments before starting the program (baseline) and immediately after the final session.
- Participate in a qualitative feedback interview after the final 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
- Treatment
- 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
- •Chinese aged at least 18 years old;
- •Written informed consent of participation in the study is given by the participant
- •Willing to comply with the study protocol
- •having a child with neurodevelopment disorder (e.g., ASD, ADHD)
排除标准
- •having been enrolled in any other clinical trial or investigational products within one month at the entry of the study, or having extensive experience in mindfulness practice
- •In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt)
- •Currently receiving any structured psychotherapy
- •With hearing or speech deficit
结局指标
主要结局
Change in stress level
时间窗: Baseline, end of treatment at 8 weeks
Stress was measured using the 14-item Perceived Stress Scale (PSS). Possible scores range from 0 to 56, with higher scores indicating higher stress level .
次要结局
- Change in depressive symptoms(Baseline, end of treatment at 8 weeks)
- Change in anxiety symptoms(Baseline, end of treatment at 8 weeks)
- Change in insomnia symptoms(Baseline, end of treatment at 8 weeks)
- Change in mindfulness ability(Baseline, end of treatment at 8 weeks)
研究者
Dr. Shirley Xin Li
Associate Professor
The University of Hong Kong