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临床试验/NCT05746468
NCT05746468尚未招募不适用

The Mechanism and Effectiveness of Mindfulness-based Intervention for Reducing the Psychological Distress of Parents of Children With Autism Spectrum Disorder: An Ecological Momentary Intervention and Randomized Controlled Trial

The University of Hong Kong0 个研究点目标入组 526 人开始时间: 2025年7月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
526
主要终点
Cognitive Appraisal of Health Scale

研究概览

简要总结

This study aims to develop a smartphone app based on mindfulness-based interventions and test its effectiveness in parents of children with ASD. This study aims:

  1. To establish the relationship between different life events, cognitive appraisal, and the psychological distress between parents of children with autism spectrum disorder (ASD);
  2. To demonstrate the relationship between parents' cognitive appraisal of life events and psychological distress moderated by mindfulness;
  3. To examine the effectiveness of mindfulness-based intervention (MBI) via ecological momentary intervention (EMI) in reducing the psychological distress of parents of children with ASD;
  4. To calculate the cost-effectiveness of MBI via EMI in reducing the psychological distress of parents of children with ASD.

详细描述

Existing studies have unequivocally demonstrated that parents of children with autism spectrum disorder (ASD) experience various daily life events and suffer from psychological distress. Mindfulness-based intervention (MBI) was found to be an effective buffer between parents' appraisal of life events and psychological distress. However, the mechanism behind the effectiveness was unclear, and traditional MBI in experimental settings were not tailored to personal real-life needs. This study proposed to conduct a randomized controlled trial (RCT) to examine the effectiveness and cost-effectiveness of MBI in the platform of ecological momentary intervention (EMI) in changing participants' cognitive appraisal of daily life events and reducing the psychological distress of parents of children with ASD.

This study aims to answer four research questions:

  1. What's the relationship between participants' cognitive appraisal of their life events and psychological distress?
  2. Will an increased level of mindfulness moderate the relationship between participants' cognitive appraisal of life events and psychological distress?
  3. Will the participants who received MBI via EMI report significantly lower levels of psychological distress compared with those who did not?
  4. Will the MBI via EMI be a more cost-effective option compared with the control group?

The proposed study will recruit 526 parents of children with ASD and randomly assign them into the intervention and control groups (263 in each group). Participants in the intervention group will install the EMI app on their smartphone. In the app, participants can browse different mindfulness exercises in the intervention bank at any time, talk to a virtual counselor and receive tailored mindfulness practice daily, practice formal mindfulness exercise every week, complete ecological momentary assessments on the cognitive appraisal of life events and receive a daily log of change of psychological status. Participants in the control group will only receive standardized mindfulness practice instructions 3 times/week. The effects of MBI will be assessed at the end of the intervention and at the 2-month follow-up.

The primary outcome will be participants' psychological distress measured by the depression anxiety stress scale. The secondary outcomes will include participants' subjective well-being, measured by the satisfaction with life scale, level of resilience measured by the psychological empowerment scale and the feasibility and acceptability of the EMI, measured by the treatment acceptability and adherence scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Cognitive Appraisal of Health Scale

时间窗: 2 months after the intervention

The CAHS scale will be used to measure participants' cognitive appraisal of daily life events. This scale includes 28 items rated from 1 strongly disagree to 5 strongly agree. This scale was developed based on the transactional theory of stress and coping and thus consists of subscales of primary appraisal (threat, challenge, harm/loss and benign/irrelevant) and secondary appraisal. The internal consistency were all greater than .70.

次要结局

  • The Five Facet Mindfulness Questionnaire (FFMQ)-short version(right after the intervention)
  • The Depression Anxiety Stress Scale(right after the intervention)
  • Satisfaction with Life Scale(right after the intervention)
  • Psychological Empowerment Scale for parents of children with a disability(right after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaochen Zhou

Research Assistant Professor

The University of Hong Kong

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