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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05927116

Collaborator

(none)

700

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder Parent-Child Relations	Other: Mobile phone app-based intervention for supporting and empowering parents of children with autism spectrum disorder (ASD)	N/A

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 coronavirus pandemic (COVID-19), we aim 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 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 pragmatic, randomized waitlist-controlled trial will be conducted. 700 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. 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. Outcome measurement of pre- and post-intervention from the two groups of participants will be analysed with a Mixed Factorial ANOVA. A treatment x time effect on the outcome measurement is expected.

The results of the proposed study will provide 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 this sizable clinical 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 Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised wait-list controlled trialRandomised wait-list controlled trial

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Mobile Phone App-based Intervention for Supporting and Empowering Parents of Children With Autism Spectrum Disorder (ASD): a Randomised Waitlist-controlled Trial

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate intervention 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) TRIP is a mobile app-based intervention comprises of a 6-week structured training on mindfulness and educational modules on ASD parenting skills. Other Names: TRIP app for ASD parents
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

Arm

Intervention/Treatment

Experimental: Immediate intervention

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)

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

Other Names:

TRIP app for ASD parents

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

Outcome Measures

Primary Outcome Measures

Parental anxiety [Pre-intervention]
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 [Immediately post-intervention]
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 [2-months post-intervention]
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 [Pre-intervention]
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 [Immediately post-intervention]
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 [2-months post-intervention]
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 [Pre-intervention]
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 [Immediately post-intervention]
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 [2-months post-intervention]
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 [Pre-intervention]
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 [Immediately post-intervention]
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 [2-months post-intervention]
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 [Pre-intervention]
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 [Immediately post-intervention]
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 [2-months post-intervention]
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.

Secondary Outcome Measures

App usability [Immediately post-intervention]
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 satisfaction [Immediately post-intervention]
App satisfaction will be measured by open-ended questions regarding suggestions for improvement of the app, for the purpose of refinement of the app.
Number of app usage days beyond the 6-week structured intervention [6-months post-intervention]
Number of days with logins beyond the 6-week intervention period
Average duration of app usage beyond the 6-week structured intervention [6-months post-intervention]
Time spent in app per login beyond the 6-week intervention period
Number of mindfulness practices completed beyond the 6-week structured intervention [6-months post-intervention]
Number of guided mindfulness sessions beyond the 6-week intervention period

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 trial