Mindfulness Intervention for Parents of Children With ASD

NCT05746468 | Not Yet Recruiting DMC

• 1 other identifier: EC077/2223
• Study Type: interventional
• Target: 526
• Locations: 0 countries
• Sites: N/A

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. 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. 2.To demonstrate the relationship between parents' cognitive appraisal of life events and psychological distress moderated by mindfulness;
3. 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. 4.To calculate the cost-effectiveness of MBI via EMI in reducing the psychological distress of parents of children with ASD.

Conditions

Mindfulness

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive a combination of (1) a time-based system-triggered EMI, which will collect participants' sources and status of depression, anxiety and depression in daily life and provide instructions (audios and videos) on mindfulness practice, and (2) a longitudinal survey in parents of children with ASD. The participants will first complete a baseline questionnaire, and then participate in EMI via a smartphone application (App) for 8 consecutive weeks and receive the exercise prompts daily. The EMI will include questions of the self-reported feelings of depression, anxiety and depression. After the 8-week EMI, the participants will be invited to complete a post-experimental survey with similar questions in the baseline questionnaire. Two months after completing the EMI, participants will be contacted to complete a telephone follow-up survey with similar questions in the baseline questionnaire.

Behavioral: Ecological assessment and intervention

Control group

ACTIVE COMPARATOR

The control group will receive the longitudinal survey exactly the same as the intervention group and 8-week mindfulness-based short-messages sent by the research team on a daily basis. The messages will contain instructions of mindfulness-based practice which will be the same as the intervention group.

Behavioral: Audio-based Mindfulness intervention

Interventions

Ecological assessment and intervention BEHAVIORAL

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.

Intervention group

Audio-based Mindfulness intervention BEHAVIORAL

The control group will receive audio recordings of how to practice mindfulness at home.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Related Publications (1)

• Wang Q, Ng SM, Zhou X. The mechanism and effectiveness of mindfulness-based intervention for reducing the psychological distress of parents of children with autism spectrum disorder: A protocol of randomized control trial of ecological momentary intervention and assessment. PLoS One. 2023 Sep 13;18(9):e0291168. doi: 10.1371/journal.pone.0291168. eCollection 2023.

  PMID: 37703248 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Qi Wang

  Lingnan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaochen Zhou

CONTACT

51610558; xczhou@hku.hk

Qi Wang

CONTACT

26168617; vickywang@ln.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: July 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available after 6 months of the completion of the whole study.
• Access Criteria: All scholars who can access the website.