ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626000361303

Ethics application status

Approved

Date submitted

9/01/2026

Date registered

23/03/2026

Date last updated

23/03/2026

Date data sharing statement initially provided

23/03/2026

Type of registration

Retrospectively registered

Titles & IDs

Public title

A study in Malaysia comparing a one-day parent workshop and the WHO caregiver skills training eLearning module (alone or together) for families of preschool children with autism: effects on parents’ confidence and wellbeing, and children’s behaviour and autism symptoms

Scientific title

A four-arm randomised controlled trial in Malaysia among caregivers of preschool children with autism comparing a one-day parent training workshop and WHO Caregiver Skills Training eLearning (alone and in combination) on parents' confidence and wellbeing, and children's behaviour and autism symptoms.

Additional trial identifiers [1]

NMRR ID-23-03296-ONR (issued by National Medical Research Register, Malaysia)

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Autism Spectrum Disorder

Caregiver depression

developmental delay

Child behavioural difficulties

child emotional difficulties

Caregiver anxiety

Caregiver stress

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Mental Health

Anxiety

Mental Health

Depression

Mental Health

Other mental health disorders

Mental Health

Studies of normal psychology, cognitive function and behaviour

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

This study evaluates the effectiveness of two parent-mediated interventions (PMI).

The first PMI is a one day, in-person parent training workshop (PW) delivered in a lecture hall. Lectures are delivered by a multidisciplinary team consisting of developmental pediatricians, speech therapists, clinical psychologists and occupational therapists on autism-related topics over an 8-hour period. Lectures include general knowledge on Autism, screen time, Hanen approach, Picture Exchange Communication System (PECS), behavioural management, managing sensory issues and recommendations on available local facilities. Participants will attend this workshop only once during the study period.

The second PMI is the e-Learning module (EL) of the World Health Organization Caregiver Skills Training Programme for Families of Children with Developmental Delays and Disabilities (CST). Lessons are divided into several core modules which include engagement, play and home routines, communication, behaviour management, adaptive behaviour, caregiver self-care and ongoing practice. On 2nd April 2022, the WHO launched the online version of the CST Programme which includes pre-recorded information sessions, allowing caregivers to learn at their own pace, and fit the course into their own schedules in a way that suits them. The programme is currently accessible for free at WHO Academy. It is designed to be completed in around 2.5 months and involves about 8 hours of total lesson time. Participants will be asked to complete the EL at their own pace and show the Record of Achievement (issued to participants who have correctly answered at least 80% of post-test questions) to the investigators during follow up.

Participants will be randomised to 3 intervention arms and 1 control arm.
Arm 1: Parent workshop only
Arm 2: eLearning module of CST only
Arm 3: combination of both parent workshop and EL-CST.

Adherence is defined as
Arm 1: Attended the parent workshop
Arm 2: Obtaining the Record of Achievement by the fullow up period
Arm 3: Attended the parent workshop AND obtained the Record of Achievement

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Description of the comparator or control

The control condition was a waitlist group receiving treatment as usual, with access to both parent-mediated interventions provided after completion of the study follow-up.

All study participants received standard care, which include an audiology assessment, referral to occupational therapy, speech therapy, advice on relevant therapy centres and suitable resources (books and websites).

Control group

Active

Outcomes

Primary outcome [1]

Parenting Competence

Timepoint [1]

baseline (T0) and follow up (T1) *T1 will occur at a common time point for all study participants, regardless of randomisation arm. This will be approximately 6 months after the parent workshop is conducted.

Primary outcome [2]

Child autism-related social communication deficits

Timepoint [2]

baseline (T0) and follow up (T1)

Primary outcome [3]

Child behavioural and emotional difficulties (this will be assessed as a composite outcome using the below assessment method)

Timepoint [3]

baseline (T0) and follow up (T1)

Secondary outcome [1]

Parent mental health

Timepoint [1]

baseline (T0) and follow up (T1)

Eligibility

Key inclusion criteria

Parents and caregivers of children who fulfil the below criteria
1) Children between 30 months to 72 months old
2) Diagnosed to have ASD using the DSM–5 criteria.
3) Agreed to join the study

Minimum age

30 Months

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

1) Parents who do not understand English
2) If they do not have a reliable internet connection
3) If they have already undergone the Parent workshop
4) If they have already undergone the WHO CST eLearning course
5) If the child has hearing and vision impairments
6) If the child has a history of neurological or genetic disorders
7) Inability or unwillingness to provide written consent.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation was concealed.
The groupings were prepared by an independent colleague who then placed the groupings into opaque, sealed and sequentially numbered envelopes. The envelopes were kept securely in an agreed location and accessed when needed. Families who signed the consent form were informed of their allocation by opening the subsequent numbered envelope.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

permuted block randomisation (fixed block size 8) generated by an online random number generator.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Factorial

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

18/01/2024

Date of last participant enrolment

Anticipated

Actual

14/05/2024

Date of last data collection

Anticipated

Actual

15/12/2024

Sample size

Target

112

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Sarawak, Kuching

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sarawak General Hospital

Address [1]

Country [1]

Malaysia

Primary sponsor type

Individual

Name

Ker Yung Chua, Sarawak General Hospital

Address

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Medical Research and Ethics Committee

Ethics committee address [1]

Medical Research & Ethics Committee (MREC Secretariat) Ethics and Research Surveillance Sector , Level 2, Blok A1, National Institutes of Health (NIH) No 1 Jalan Setia Murni U13/52, Seksyen U13 Bandar Setia Alam, 40170 Shah Alam

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

07/11/2023

Approval date [1]

18/01/2024

Ethics approval number [1]

23-03296-ONR

Summary

Brief summary

This study is a randomised trial in Malaysia involving caregivers of preschool children (30–72 months) diagnosed with autism spectrum disorder. We are comparing two parent training approaches: (1) a one-day, in-person parent training workshop delivered by a multidisciplinary clinical team, and (2) the World Health Organization (WHO) Caregiver Skills Training (CST) online self-directed eLearning course. Caregivers are randomly allocated to one of four groups: workshop only, eLearning only, both workshop plus eLearning, or a waitlist (usual care). We will assess whether these programmes improve parents’ sense of parenting competence and reduce symptoms of stress, anxiety and depression, and whether they improve children’s behaviour and social communication traits over six months. We hypothesise that caregivers receiving both interventions will show the greatest improvements.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Ker Yung Chua

Address

Sarawak General Hospital, Jalan Hospital, 93586 Kuching, Sarawak

Country

Malaysia

Phone

+60129286081

Fax

[email protected]

Contact person for public queries

Name

Ker Yung Chua

Address

Sarawak General Hospital, Jalan Hospital, 93586 Kuching, Sarawak

Country

Malaysia

Phone

+60129286081

Fax

[email protected]

Contact person for scientific queries

Name

Ker Yung Chua

Address

Sarawak General Hospital, Jalan Hospital, 93586 Kuching, Sarawak

Country

Malaysia

Phone

+60129286081

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)

What types of analyses could be done with individual participant data?

• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
Not yet decided

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: Requests for de-identified individual participant data may be made by email to the trial custodian (principal investigator) at [email protected]. Access will be considered on reasonable request after publication, subject to approval of a data-sharing agreement and any applicable ethics/governance requirements.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Study protocol					study protocol - ANZTR submission 8jan2026.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically