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

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

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.

Study Overview

• Status: Completed
• Conditions: Parent-Child Relations; Autism Spectrum Disorder
• Intervention / Treatment: Other: TRIP

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRIP App; 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; 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.
No Intervention: Waitlist control; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-intervention
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.	Immediately post-intervention
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.	2-months post-intervention
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.	Pre-intervention
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.	Immediately post-intervention
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.	2-months post-intervention
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.	Pre-intervention
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.	Immediately post-intervention
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.	2-months post-intervention
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.	Pre-intervention
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.	Immediately post-intervention
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.	2-months post-intervention
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.	Pre-intervention
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.	Immediately post-intervention
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.	2-months post-intervention

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Oscar Wong, MBChB, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): August 5, 2024
• Study Completion (Actual): August 5, 2024

Study Registration Dates

• First Submitted: June 4, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: mindfulness; parenting; psychoeducation; digital interventions
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 2022.586; 10210356 (Other Grant/Funding Number: Health and Medical Research Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No