Mindfulness Intervention for Parents of Children With ASD

Mindfulness Clinical Trial

— MAPASD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05746468
• Other study ID #: EC077/2223
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: The University of Hong Kong
• Contact: Xiaochen Zhou
• Phone: 51610558
• Email: xczhou[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 526
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

The inclusion criteria will comprise

• parents of children with ASD (children aged between 6-18 and diagnosed with different functional levels of ASD by certified psychologists);

• own a mobile smartphone with internet access;

• will stay in Hong Kong during the 8-week EMI study period, and

• able to read and write in Chinese.

The exclusion criteria will include

• parents diagnosed with depression, anxiety, and stress disorder by certified doctors; and

• parents who do not live together with their children with ASD on the daily basis.

Related Conditions & MeSH terms

• Mindfulness

Intervention

Behavioral:
• Ecological assessment and intervention
The MBI-EMI app will include five main parts, including virtual counselor, intervention library, weekly mindfulness practice, assessment bank and daily emotion log. In the eight weeks, the virtual counselor will initiate the conversation every day for three times (morning, afternoon and evening) to check the status of the participants. If the participants responded, the virtual counselor would invite the participants to rate their level of depression, stress and anxiety and then recommend appropriate mindfulness practice in the intervention library, such as 3-minute breathing space or mindful eating. The conversation between the virtual counselor and participants will be in the format of menu list and participants can easily choose from different options.
• Audio-based Mindfulness intervention
The control group will receive audio recordings of how to practice mindfulness at home.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Appraisal of Health Scale	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.	right after the intervention
Primary	Cognitive Appraisal of Health Scale	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.	2 months after the intervention
Secondary	The Five Facet Mindfulness Questionnaire (FFMQ)-short version	will be used to measure participants' level of mindfulness before and after practicing. It includes 15 items measuring the five facets of mindfulness: observing, describing, acting with awareness, non-judging of inner experience and non-reactivity to inner experience. This scale was further validated and yield good convergent validity and internal consistency. The items will be rated using 1 (very rare)-5 (very often) Likert scale with higher score indicate higher level of mindfulness.	right after the intervention
Secondary	The Depression Anxiety Stress Scale	DASS is a self-report questionnaire that measures the emotional states of depression, anxiety, and stress. This scale contains 21 questions rated from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). There were seven questions for each one sub-scale of stress, depression, and anxiety. This scale showed good reliability (r=0.96 and 0.80 for the depression and anxiety subscales, respectively) and Cronbach's a was high for the three subscales in parents of children with ASD: 0.91 for the stress, 0.87 for anxiety, and 0.94 for depression and 0.92 for total scale. It has also been validated in Hong Kong population.	right after the intervention
Secondary	Satisfaction with Life Scale	The SWLS has 5 items scored on a 7-point scale (1 = strongly disagree to 7 = strongly agree) measuring participants' satisfaction with life and has a Cronbach's alpha for internal consistency of .87 and a test-retest correlation of .82. This scale has also been validated in Chinese and Hong Kong population.	right after the intervention
Secondary	Psychological Empowerment Scale for parents of children with a disability	It is a 32-item questionnaire on a 5-point scale (1 = strongly disagree to 5 = strongly agree) with four underlying sub-scales: (a) attitudes of control and competence, (b) cognitive appraisals of critical skills and knowledge, (c) formal participation in organizations, and (d) informal participation in social systems and relationships. This scale showed high reliability coefficients (.90-.97).	right after the intervention