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

NCT05927207 | Completed

• 2 other identifiers: 2022.58610210356
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Parent-Child Relations

Keywords

digital interventions; parenting; mindfulness; psychoeducation

Outcome Measures

Primary Outcomes (13)

• Enrolment

  Response rates during recruitment

  Immediately post-intervention

• Retention (Intervention)

  Dropout rates from pre-intervention to immediately post-intervention

  Immediately post-intervention

• Retention (Follow-up)

  Dropout rates from pre-intervention to 2-month post intervention

  2 months post-intervention

• Platform used

  Platform on which the app is accessed from, Apple's iPhone operating system (iOS) or Android, will be recorded

  Immediately post-intervention

• Days of week of use

  Whether the app is used on weekdays or weekends will be recorded

  Immediately post-intervention

• Time of day of use

  Time of day of use (in 4-hour blocks) will be recorded

  Immediately post-intervention

• Number of app usage days

  Number of days with logins within the 6-week intervention period

  Immediately post-intervention

• Average duration of app usage

  Time spent in app per login within the 6-week intervention period

  Immediately post-intervention

• Number of unique components completed

  Number of unique components completed within the 6-week intervention period

  Immediately post-intervention

• Number of core session completed

  Number of core session completed within the 6-week intervention period

  Immediately post-intervention

• Number of optional session completed

  Number of optional session completed within the 6-week intervention period

  Immediately post-intervention

• 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.

  Immediately post-intervention

• 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.

  Immediately post-intervention

Secondary Outcomes (15)

• Parental anxiety

  Pre-intervention

• Parental anxiety

  Immediately post-intervention

• Parental anxiety

  2-months post-intervention

• Parental depression

  Pre-intervention

• Parental depression

  Immediately post-intervention

Study Arms (2)

TRIP App

EXPERIMENTAL

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

Other: TRIP

Waitlist control

NO 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

Interventions

TRIP OTHER

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.

TRIP App

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Parents who are not the main carer of their ASD children
• Currently receiving psychological interventions
• Undergoing mindfulness training will be excluded

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Oscar Wong, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Clinical)

Model Details: Randomised wait-list controlled trial

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: July 3, 2023
• Study Start: August 1, 2023
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)