Clinical trial NCT05927207: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Parent-Child Relations
Keywords: digital interventions
parenting
mindfulness
psychoeducation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised wait-list controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Enrolment
timeFrame: Immediately post-intervention
measure: Retention (Intervention)
timeFrame: Immediately post-intervention
measure: Retention (Follow-up)
timeFrame: 2 months post-intervention
measure: Platform used
timeFrame: Immediately post-intervention
measure: Days of week of use
timeFrame: Immediately post-intervention
measure: Time of day of use
timeFrame: Immediately post-intervention
measure: Number of app usage days
timeFrame: Immediately post-intervention
measure: Average duration of app usage
timeFrame: Immediately post-intervention
measure: Number of unique components completed
timeFrame: Immediately post-intervention
measure: Number of core session completed
timeFrame: Immediately post-intervention
measure: Number of optional session completed
timeFrame: Immediately post-intervention
measure: App usability
timeFrame: Immediately post-intervention
measure: App quality
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Parental anxiety
timeFrame: Pre-intervention
measure: Parental anxiety
timeFrame: Immediately post-intervention
measure: Parental anxiety
timeFrame: 2-months post-intervention
measure: Parental depression
timeFrame: Pre-intervention
measure: Parental depression
timeFrame: Immediately post-intervention
measure: Parental depression
timeFrame: 2-months post-intervention
measure: Parenting stress
timeFrame: Pre-intervention
measure: Parenting stress
timeFrame: Immediately post-intervention
measure: Parenting stress
timeFrame: 2-months post-intervention
measure: Parenting competence
timeFrame: Pre-intervention
measure: Parenting competence
timeFrame: Immediately post-intervention
measure: Parenting competence
timeFrame: 2-months post-intervention
measure: Parenting efficacy
timeFrame: Pre-intervention
measure: Parenting efficacy
timeFrame: Immediately post-intervention
measure: Parenting efficacy
timeFrame: 2-months post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Oscar Wong, MBChB
role: PRINCIPAL_INVESTIGATOR
References: