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

NCT05927116 | Completed

• 2 other identifiers: 2022.58410210356
• Study Type: interventional
• Target: 852
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the effectiveness of a 6-week mobile app-based intervention in empowering and supporting Chinese parents of ASD children through knowledge and skills transfer and mindfulness training, to explore factors associated with enhanced user experiences and sustained usage through participants' qualitative feedback and observing naturalistic usage patterns beyond the active intervention period, and to refine the mobile app based on the data prior to wider dissemination of the app. We hypothesise 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

Parent-Child Relations; Autism Spectrum Disorder

Keywords

digital interventions; parenting; mindfulness; psychoeducation

Outcome Measures

Primary Outcomes (15)

• 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

Secondary Outcomes (5)

• App usability

  Immediately post-intervention

• App satisfaction

  Immediately post-intervention

• Number of app usage days beyond the 6-week structured intervention

  6-months post-intervention

• Average duration of app usage beyond the 6-week structured intervention

  6-months post-intervention

• Number of mindfulness practices completed beyond the 6-week structured intervention

  6-months post-intervention

Study Arms (2)

Immediate intervention

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: Mobile phone app-based intervention for supporting and empowering parents of children with autism spectrum disorder (ASD)

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

Mobile phone app-based intervention for supporting and empowering parents of children with autism spectrum disorder (ASD) OTHER

TRIP is a mobile app-based intervention comprises of a 6-week structured training on mindfulness and educational modules on ASD parenting skills.

Also known as: TRIP app for ASD parents

Immediate intervention

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 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

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

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: January 1, 2024
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)