MindfulnessMAPASDNCT05746468
Mindfulness Intervention for Parents of Children With ASD
A study testing Ecological assessment and intervention and Audio-based Mindfulness intervention in people with Mindfulness, run by The University of Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness
- What is being tested?
- Ecological assessment and intervention and Audio-based Mindfulness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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:
- To establish the relationship between different life events, cognitive appraisal, and the psychological distress between parents of children with autism spectrum disorder (ASD);
- To demonstrate the relationship between parents' cognitive appraisal of life events and psychological distress moderated by mindfulness;
- 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;
- To calculate the cost-effectiveness of MBI via EMI in reducing the psychological distress of parents of children with ASD.
Read the 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:
- What's the relationship between participants' cognitive appraisal of their life events and psychological distress?
- Will an increased level of mindfulness moderate the relationship between participants' cognitive appraisal of life events and psychological distress?
- Will the participants who received MBI via EMI report significantly lower levels of psychological distress compared with those who did not?
- 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.
- Conditions
- Mindfulness
- Being tested
- Ecological assessment and intervention, Audio-based Mindfulness intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological assessment and interventionBehavioural
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 interventionBehavioural
The control group will receive audio recordings of how to practice mindfulness at home.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Audio-based Mindfulness intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months after the intervention
Secondary outcomes (4)
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.
Measured: right after the intervention
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 α 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.
Measured: right after the intervention
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.
Measured: right after the intervention
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).
Measured: right after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study startJul 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaochen Zhou, The University of Hong Kong
- Investigators
- Qi Wang, Principal investigator, Lingnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746468
- Sponsor's protocol ID
- EC077/2223
- Acronym
- MAPASD
- Status last verified
- Dec 2024
- First submitted
- 16 Feb 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of the primary and secondary outcomes will be shared
Publications
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.
PubMed 37703248
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05746468
- Acronym / sponsor ID
- MAPASD / EC077/2223
- Conditions
- Mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To establish the relationship between different life events, cognitive appraisal, and the psychological distress between parents of children with autism spectrum disorder (ASD);
- To demonstrate the relationship between parents' cognitive appraisal of life events and psychological distress moderated by mindfulness;
- 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;
- 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:
- What's the relationship between participants' cognitive appraisal of their life events and psychological distress?
- Will an increased level of mindfulness moderate the relationship between participants' cognitive appraisal of life events and psychological distress?
- Will the participants who received MBI via EMI report significantly lower levels of psychological distress compared with those who did not?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Ecological assessment and interventionThe 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. |
| Control group | Active comparator | Behavioral: Audio-based Mindfulness interventionThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological assessment and interventionThe 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. | Behavioural | Intervention group |
| Audio-based Mindfulness interventionThe control group will receive audio recordings of how to practice mindfulness at home. | Behavioural | Control group |
Primary outcome
Cognitive Appraisal of Health Scale
Time frame: right 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.
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.
4 secondary outcomes
The Five Facet Mindfulness Questionnaire (FFMQ)-short version
Time frame: right after the intervention
The Depression Anxiety Stress Scale
Time frame: right after the intervention
Satisfaction with Life Scale
Time frame: right after the intervention
Psychological Empowerment Scale for parents of children with a disability
Time frame: right after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 37703248Wang 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.
- Individual participant dataSharing planned: Yes. The data of the primary and secondary outcomes will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qi Wang principal investigator
Lingnan University
Questions about this trial
What is this clinical trial studying?
A study testing Ecological assessment and intervention and Audio-based Mindfulness intervention in people with Mindfulness, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaochen Zhou (51610558, xczhou@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Appraisal of Health Scale (time frame: right after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05746468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.