Clinical trial NCT05927116: RCT of a Mobile Phone App-based Intervention for Parents of Children With Autism Spectrum Disorder (ASD)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
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: 700
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 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.

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.

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 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: 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
Secondary outcomes:
measure: App usability
timeFrame: Immediately post-intervention
measure: App satisfaction
timeFrame: Immediately post-intervention
measure: Number of app usage days beyond the 6-week structured intervention
timeFrame: 6-months post-intervention
measure: Average duration of app usage beyond the 6-week structured intervention
timeFrame: 6-months post-intervention
measure: Number of mindfulness practices completed beyond the 6-week structured intervention
timeFrame: 6-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: