An interventional study of Ecological assessment and intervention and Audio-based Mindfulness intervention in Mindfulness, sponsored by The University of Hong Kong. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Supportive care
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:
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:
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.
The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria will comprise
The exclusion criteria will include
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
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
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.
The control group will receive audio recordings of how to practice mindfulness at home.
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.
Time frame: 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.
Time frame: 2 months after the intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: right after the intervention
No study locations are listed for this record.
Plan to share: Yes — The data of the primary and secondary outcomes will be shared
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Hong Kong