MedDataX Logo

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

NCT ID: NCT05927207

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder Parent-Child Relations

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

digital interventions parenting mindfulness psychoeducation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised wait-list controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

TRIP

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wong Wing Ho

Assistant Professor (Clinical)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oscar Wong, MBChB

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022.586

Identifier Type: -

Identifier Source: org_study_id

10210356

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id