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Pilot Testing of a Mobile Phone App-based Intervention for Parents of Children With Autism Spectrum Disorder (ASD)

Primary Purpose

Autism Spectrum Disorder, Parent-Child Relations

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TRIP
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring digital interventions, parenting, mindfulness, psychoeducation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Chinese parents living in Hong Kong Parents caring for ASD children, diagnosed by clinicians according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and aged ≤12 Recruited from the Child and Adolescent Psychiatric clinic at the Alice Ho Miu Ling Nethersole Hospital, a regional hospital providing the sole public child and adolescent psychiatric service in the New-Territory East Cluster of the Hospital Authority in Hong Kong Able to read and understand Cantonese Have access to an internet-enabled mobile phone with a valid phone number for the duration of the pilot trial Exclusion Criteria: Parents who are not the main carer of their ASD children Currently receiving psychological interventions Undergoing mindfulness training will be excluded

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    TRIP App

    Waitlist control

    Arm Description

    Both groups will be assessed at baseline on the outcome measurements, after which the immediate intervention group will begin the 6-week intervention

    Both groups will be assessed at baseline on the outcome measurements, after which the the waitlist control group will receive usual care in the following six weeks. Afterwards, the waitlist control group will complete outcome assessment once again, before receiving the 6-week intervention

    Outcomes

    Primary Outcome Measures

    Enrolment
    Response rates during recruitment
    Retention (Intervention)
    Dropout rates from pre-intervention to immediately post-intervention
    Retention (Follow-up)
    Dropout rates from pre-intervention to 2-month post intervention
    Platform used
    Platform on which the app is accessed from, Apple's iPhone operating system (iOS) or Android, will be recorded
    Days of week of use
    Whether the app is used on weekdays or weekends will be recorded
    Time of day of use
    Time of day of use (in 4-hour blocks) will be recorded
    Number of app usage days
    Number of days with logins within the 6-week intervention period
    Average duration of app usage
    Time spent in app per login within the 6-week intervention period
    Number of unique components completed
    Number of unique components completed within the 6-week intervention period
    Number of core session completed
    Number of core session completed within the 6-week intervention period
    Number of optional session completed
    Number of optional session completed within the 6-week intervention period
    App usability
    Measured by the 10-item System Usability Scale (SUS; Brooke, 1996) for assessing the usability of products and apps. SUS scores have a range of 0 to 100, with a higher score means greater app usability.
    App quality
    Measured by the 20-item Mobile Application Rating Scale - User Version (uMARS; Stoyanov et al., 2016) that measures engagement, functionality, aesthetics, information quality of mobile health apps. Scores range from 1 to 5, with a higher score indicating higher app quality.

    Secondary Outcome Measures

    Parental anxiety
    Measured by the 7-item Generalised Anxiety Disorder scale (GAD-7; Spitzer et al., 2006) for anxiety symptoms. GAD-7 scores range from 0 to 21, higher scores indicating greater levels of anxiety symptoms.
    Parental anxiety
    Measured by the 7-item Generalised Anxiety Disorder scale (GAD-7; Spitzer et al., 2006) for anxiety symptoms. GAD-7 scores range from 0 to 21, higher scores indicating greater levels of anxiety symptoms.
    Parental anxiety
    Measured by the 7-item Generalised Anxiety Disorder scale (GAD-7; Spitzer et al., 2006) for anxiety symptoms. GAD-7 scores range from 0 to 21, higher scores indicating greater levels of anxiety symptoms.
    Parental depression
    Measured by the 9-item Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) for depressive symptoms. PHQ-9 scores range from 0 to 27, higher scores indicating greater levels of depressive symptoms.
    Parental depression
    Measured by the 9-item Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) for depressive symptoms. PHQ-9 scores range from 0 to 27, higher scores indicating greater levels of depressive symptoms.
    Parental depression
    Measured by the 9-item Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) for depressive symptoms. PHQ-9 scores range from 0 to 27, higher scores indicating greater levels of depressive symptoms.
    Parenting stress
    Measured by the 36-item Parenting Stress Index-Short Form (PSI-SF), considering three domains of parenting distress, difficult child, and parent-child dysfunctional interaction. Scores range from 36 to 180, with higher scores indicating greater levels of stress.
    Parenting stress
    Measured by the 36-item Parenting Stress Index-Short Form (PSI-SF), considering three domains of parenting distress, difficult child, and parent-child dysfunctional interaction. Scores range from 36 to 180, with higher scores indicating greater levels of stress.
    Parenting stress
    Measured by the 36-item Parenting Stress Index-Short Form (PSI-SF), considering three domains of parenting distress, difficult child, and parent-child dysfunctional interaction. Scores range from 36 to 180, with higher scores indicating greater levels of stress.
    Parenting competence
    Measured by the 17-item Parenting Sense of Competence scale (PSOC; Gibaud-Wallston & Wandersman, 1978). Scores ranges between 17 to 102, with higher scores indicating a higher parenting sense of competency.
    Parenting competence
    Measured by the 17-item Parenting Sense of Competence scale (PSOC; Gibaud-Wallston & Wandersman, 1978). Scores ranges between 17 to 102, with higher scores indicating a higher parenting sense of competency.
    Parenting competence
    Measured by the 17-item Parenting Sense of Competence scale (PSOC; Gibaud-Wallston & Wandersman; 1978). Scores ranges between 17 to 102, with higher scores indicating a higher parenting sense of competency.
    Parenting efficacy
    Measured by the 6-item Parenting Efficacy subscale of the Parenting Self-Agency Measure (Dumka et al., 1996). Scores ranges between 6-42, with higher scores indicating higher levels of parenting efficacy.
    Parenting efficacy
    Measured by the 6-item Parenting Efficacy subscale of the Parenting Self-Agency Measure (Dumka et al., 1996). Scores ranges between 6-42, with higher scores indicating higher levels of parenting efficacy.
    Parenting efficacy
    Measured by the 6-item Parenting Efficacy subscale of the Parenting Self-Agency Measure (Dumka et al., 1996). Scores ranges between 6-42, with higher scores indicating higher levels of parenting efficacy.

    Full Information

    First Posted
    June 4, 2023
    Last Updated
    June 23, 2023
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05927207
    Brief Title
    Pilot Testing of a Mobile Phone App-based Intervention for Parents of Children With Autism Spectrum Disorder (ASD)
    Official Title
    Pilot Testing of a Mobile Phone App-based Intervention for Supporting and Empowering Parents of Children With Autism Spectrum Disorder (ASD): a Mixed-method Study of Feasibility, Acceptability, and Preliminary Efficacy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    February 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study is to conduct a pilot randomised controlled trial (RCT) evaluating the feasibility, acceptability, and preliminary efficacy of a 6-week mobile app-based intervention in empowering and supporting Chinese parents of autism spectrum disorder (ASD) children through knowledge and skills transfer and mindfulness training. The investigators hypothesise that the app will be feasible and acceptable, and that there will be a greater reduction in parental stress and mood symptoms, and improvement of mindfulness attitude and parenting competence in parents with ASD children after the 6-week app-based intervention than the waitlist controls.
    Detailed Description
    Parents of autism spectrum disorder (ASD) children are often stressed about challenges in raising their children with multifaceted needs, and their stress could undermine the child's development. With the ever-increasing demand in clinical services and disruptions by the coronavirus pandemic (COVID-19), the aim of the study is to investigate the clinical efficacy of a mobile app-based intervention in reducing stress and mood symptoms, and enhancing mindfulness and competence in parents of children with ASD. The 6-week mobile app-based intervention programme, TRIP, is a structured course of mindfulness training, and knowledge and skills transfer of parenting ASD children with specific content personalised to the participant's needs, which was developed as an accessible and scalable primary-level care platform to improve the well-being of parents. In this study, a pilot randomized waitlist-controlled trial will be conducted. 40 parents of ASD children who are ≤12 years of age and either 1. waiting for, or 2. actively receiving treatment from a regional children psychiatric specialist clinic will be recruited. Parents will be randomized into an immediate intervention arm and a waitlist arm. Feasibility, acceptability, as well as preliminary efficacy of the app will be investigated. Parental stress level, mood symptoms, competence, and level of mindfulness will be measured before, immediately after, and 2 months after the intervention with self-reported questionnaires. The results of the proposed study will provide insights with regards to the design and implementation of the main randomised controlled trial (RCT), contributing to the generation of evidence to the real-life efficacy of a mobile app-based intervention service model to support parents of children with ASD in the era of digital mental health. As the impact of mental well-being of parents extends beyond the parents themselves, effective management of the elevated level of parental stress in ASD families is beneficial to the family functioning and long-term development of the child. The solid evidence from the main trial can also inform clinicians and service-users in choosing the evidence-based intervention suitable to their context, among the range of commercially available products with claimed efficacy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder, Parent-Child Relations
    Keywords
    digital interventions, parenting, mindfulness, psychoeducation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomised wait-list controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TRIP App
    Arm Type
    Experimental
    Arm Description
    Both groups will be assessed at baseline on the outcome measurements, after which the immediate intervention group will begin the 6-week intervention
    Arm Title
    Waitlist control
    Arm Type
    No Intervention
    Arm Description
    Both groups will be assessed at baseline on the outcome measurements, after which the the waitlist control group will receive usual care in the following six weeks. Afterwards, the waitlist control group will complete outcome assessment once again, before receiving the 6-week intervention
    Intervention Type
    Other
    Intervention Name(s)
    TRIP
    Intervention Description
    TRIP is a mobile app-based intervention for supporting and empowering parents of children with autism spectrum disorder (ASD), comprises of a 6-week structured training on mindfulness and educational modules on ASD parenting skills.
    Primary Outcome Measure Information:
    Title
    Enrolment
    Description
    Response rates during recruitment
    Time Frame
    Immediately post-intervention
    Title
    Retention (Intervention)
    Description
    Dropout rates from pre-intervention to immediately post-intervention
    Time Frame
    Immediately post-intervention
    Title
    Retention (Follow-up)
    Description
    Dropout rates from pre-intervention to 2-month post intervention
    Time Frame
    2 months post-intervention
    Title
    Platform used
    Description
    Platform on which the app is accessed from, Apple's iPhone operating system (iOS) or Android, will be recorded
    Time Frame
    Immediately post-intervention
    Title
    Days of week of use
    Description
    Whether the app is used on weekdays or weekends will be recorded
    Time Frame
    Immediately post-intervention
    Title
    Time of day of use
    Description
    Time of day of use (in 4-hour blocks) will be recorded
    Time Frame
    Immediately post-intervention
    Title
    Number of app usage days
    Description
    Number of days with logins within the 6-week intervention period
    Time Frame
    Immediately post-intervention
    Title
    Average duration of app usage
    Description
    Time spent in app per login within the 6-week intervention period
    Time Frame
    Immediately post-intervention
    Title
    Number of unique components completed
    Description
    Number of unique components completed within the 6-week intervention period
    Time Frame
    Immediately post-intervention
    Title
    Number of core session completed
    Description
    Number of core session completed within the 6-week intervention period
    Time Frame
    Immediately post-intervention
    Title
    Number of optional session completed
    Description
    Number of optional session completed within the 6-week intervention period
    Time Frame
    Immediately post-intervention
    Title
    App usability
    Description
    Measured by the 10-item System Usability Scale (SUS; Brooke, 1996) for assessing the usability of products and apps. SUS scores have a range of 0 to 100, with a higher score means greater app usability.
    Time Frame
    Immediately post-intervention
    Title
    App quality
    Description
    Measured by the 20-item Mobile Application Rating Scale - User Version (uMARS; Stoyanov et al., 2016) that measures engagement, functionality, aesthetics, information quality of mobile health apps. Scores range from 1 to 5, with a higher score indicating higher app quality.
    Time Frame
    Immediately post-intervention
    Secondary Outcome Measure Information:
    Title
    Parental anxiety
    Description
    Measured by the 7-item Generalised Anxiety Disorder scale (GAD-7; Spitzer et al., 2006) for anxiety symptoms. GAD-7 scores range from 0 to 21, higher scores indicating greater levels of anxiety symptoms.
    Time Frame
    Pre-intervention
    Title
    Parental anxiety
    Description
    Measured by the 7-item Generalised Anxiety Disorder scale (GAD-7; Spitzer et al., 2006) for anxiety symptoms. GAD-7 scores range from 0 to 21, higher scores indicating greater levels of anxiety symptoms.
    Time Frame
    Immediately post-intervention
    Title
    Parental anxiety
    Description
    Measured by the 7-item Generalised Anxiety Disorder scale (GAD-7; Spitzer et al., 2006) for anxiety symptoms. GAD-7 scores range from 0 to 21, higher scores indicating greater levels of anxiety symptoms.
    Time Frame
    2-months post-intervention
    Title
    Parental depression
    Description
    Measured by the 9-item Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) for depressive symptoms. PHQ-9 scores range from 0 to 27, higher scores indicating greater levels of depressive symptoms.
    Time Frame
    Pre-intervention
    Title
    Parental depression
    Description
    Measured by the 9-item Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) for depressive symptoms. PHQ-9 scores range from 0 to 27, higher scores indicating greater levels of depressive symptoms.
    Time Frame
    Immediately post-intervention
    Title
    Parental depression
    Description
    Measured by the 9-item Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) for depressive symptoms. PHQ-9 scores range from 0 to 27, higher scores indicating greater levels of depressive symptoms.
    Time Frame
    2-months post-intervention
    Title
    Parenting stress
    Description
    Measured by the 36-item Parenting Stress Index-Short Form (PSI-SF), considering three domains of parenting distress, difficult child, and parent-child dysfunctional interaction. Scores range from 36 to 180, with higher scores indicating greater levels of stress.
    Time Frame
    Pre-intervention
    Title
    Parenting stress
    Description
    Measured by the 36-item Parenting Stress Index-Short Form (PSI-SF), considering three domains of parenting distress, difficult child, and parent-child dysfunctional interaction. Scores range from 36 to 180, with higher scores indicating greater levels of stress.
    Time Frame
    Immediately post-intervention
    Title
    Parenting stress
    Description
    Measured by the 36-item Parenting Stress Index-Short Form (PSI-SF), considering three domains of parenting distress, difficult child, and parent-child dysfunctional interaction. Scores range from 36 to 180, with higher scores indicating greater levels of stress.
    Time Frame
    2-months post-intervention
    Title
    Parenting competence
    Description
    Measured by the 17-item Parenting Sense of Competence scale (PSOC; Gibaud-Wallston & Wandersman, 1978). Scores ranges between 17 to 102, with higher scores indicating a higher parenting sense of competency.
    Time Frame
    Pre-intervention
    Title
    Parenting competence
    Description
    Measured by the 17-item Parenting Sense of Competence scale (PSOC; Gibaud-Wallston & Wandersman, 1978). Scores ranges between 17 to 102, with higher scores indicating a higher parenting sense of competency.
    Time Frame
    Immediately post-intervention
    Title
    Parenting competence
    Description
    Measured by the 17-item Parenting Sense of Competence scale (PSOC; Gibaud-Wallston & Wandersman; 1978). Scores ranges between 17 to 102, with higher scores indicating a higher parenting sense of competency.
    Time Frame
    2-months post-intervention
    Title
    Parenting efficacy
    Description
    Measured by the 6-item Parenting Efficacy subscale of the Parenting Self-Agency Measure (Dumka et al., 1996). Scores ranges between 6-42, with higher scores indicating higher levels of parenting efficacy.
    Time Frame
    Pre-intervention
    Title
    Parenting efficacy
    Description
    Measured by the 6-item Parenting Efficacy subscale of the Parenting Self-Agency Measure (Dumka et al., 1996). Scores ranges between 6-42, with higher scores indicating higher levels of parenting efficacy.
    Time Frame
    Immediately post-intervention
    Title
    Parenting efficacy
    Description
    Measured by the 6-item Parenting Efficacy subscale of the Parenting Self-Agency Measure (Dumka et al., 1996). Scores ranges between 6-42, with higher scores indicating higher levels of parenting efficacy.
    Time Frame
    2-months post-intervention

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Chinese parents living in Hong Kong Parents caring for ASD children, diagnosed by clinicians according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and aged ≤12 Recruited from the Child and Adolescent Psychiatric clinic at the Alice Ho Miu Ling Nethersole Hospital, a regional hospital providing the sole public child and adolescent psychiatric service in the New-Territory East Cluster of the Hospital Authority in Hong Kong Able to read and understand Cantonese Have access to an internet-enabled mobile phone with a valid phone number for the duration of the pilot trial Exclusion Criteria: Parents who are not the main carer of their ASD children Currently receiving psychological interventions Undergoing mindfulness training will be excluded
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Oscar Wong, MBChB
    Phone
    +85261129895
    Email
    oscarwhwong@cuhk.edu.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karen Ma, MPhil
    Phone
    +85294001865
    Email
    kykma@link.cuhk.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Oscar Wong, MBChB
    Organizational Affiliation
    Chinese University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pilot Testing of a Mobile Phone App-based Intervention for Parents of Children With Autism Spectrum Disorder (ASD)

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