跳至主要内容
临床试验/NCT04243694
NCT04243694撤回不适用

Sustainable Mindfulness and Resilience Training (SMART)

University of California, San Francisco2 个研究点 分布在 1 个国家开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Acceptance of child's diagnosis: Acceptance of Diagnosis of Autism-modified scale

研究概览

简要总结

Investigators are proposing a 6-week mindfulness and resilience training intervention tailored for caregivers of children with autism. Investigators will assess increases the caregiver's well-being and levels of psychological acceptance of their life situation as it relates to their child with autism. The mindfulness training focuses on self-regulation of emotional responses and acceptance of internal experiences. Self-report measures and qualitative interviews will be administered at baseline and post-intervention. Investigators will compare the active group to a control group of caregivers who are on the waitlist to receive the intervention.

详细描述

Investigators will prospectively examine a sample comprised of parental caregivers (ages 20 to 60) of children with autism spectrum disorder (ages 3 to 12) to determine how responses to the chronic stress of caregiving may contribute to psychological distress (e.g depression, caregiving burden, self-reported sleep).

All participants:

Participants will be randomized into the active group vs. wait list control group. Investigators will assess indices of psychological health at 2 time points over 6 weeks (length of intervention) - a Baseline Assessment, and a Follow-up Assessment. Both baseline and follow-up assessments include the same battery of questionnaires.

Daily/nightly diaries will also be completed by participants in the 7 days leading up to the baseline and follow-up time points.

In addition to self-report measures, investigators will conduct a 20-25 minute qualitative interview with caregivers both pre and post-intervention. The interview is optional and will be conducted via telephone before beginning the six-week course and within two weeks of finishing the course. The interview will be used to assess caregiver's acceptance of their child's condition and better understand their personal perception of their own acceptance. Interviews questions will be open-ended and may be modified based on the caregiver's response. An example question includes, "How hard has it been to accept your child has ASD?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-60 years old
  • Full time caregiver for a child with ASD, aged 3 to 12
  • Child diagnosed with ASD for a minimum of 6 months
  • English Speaking

排除标准

  • Any conditions that may make it difficult to participate in a mindfulness group (e.g., psychotic disorder, personality disorder)

结局指标

主要结局

Acceptance of child's diagnosis: Acceptance of Diagnosis of Autism-modified scale

时间窗: 6 weeks

Measured by the Acceptance of Diagnosis of Autism-modified scale (example item "I have a greater acceptance of my child's challenges than I used to.")

Acceptance of one's negative experiences (experiential avoidance, negative emotions and thoughts): Acceptance and Action Questionnaire

时间窗: 6 weeks

Measured by the Acceptance and Action Questionnaire (example item rating on a scale "I'm afraid of my feelings", the Brief Experiential Avoidance Questionnaire (measures intentional avoidance of thoughts, feelings and experiences associated with distress), and the Self Compassion Scale (measures the degree to which individuals display self-kindness against self-judgment, common humanity versus isolation, and mindfulness versus over-identification).

Acceptance of one's momentary situation as assessed by daily mind states (mind wandering, rejection vs. engagement in current moment): daily diary assessments

时间窗: 6 weeks

Measured by daily diary assessments

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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