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Clinical Trials/NCT05746468
NCT05746468
Not yet recruiting
Not Applicable

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 sites526 target enrollmentJuly 2025
ConditionsMindfulness

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mindfulness
Sponsor
The University of Hong Kong
Enrollment
526
Primary Endpoint
Cognitive Appraisal of Health Scale
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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. The potential benefit of the proposed study is to increase psychological well-being of parents of children with ASD and the method may extend to other participants in the future.

Registry
clinicaltrials.gov
Start Date
July 2025
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiaochen Zhou

Research Assistant Professor

The University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cognitive Appraisal of Health Scale

Time Frame: 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.

Secondary Outcomes

  • 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)

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