Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000750381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
8/06/2026
Date registered
Help: Date registered
23/06/2026
Date last updated
Help: Date last updated
23/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/06/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot Study of the Supporting Child Mental Health Program for Parents of Children from Diverse Cultural Backgrounds
Scientific title
Effects of the Supporting Child Mental Health Program on Adults’ Knowledge, Attitudes, and Helping Skills for Child Mental Health in Culturally Diverse Families with Children Aged 5–12 Years: A Pilot Study
Additional trial identifiers [1] 317225 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records
ACTRN12625000788471
Supporting Child Mental Health: An evaluation of a new training program for adults providing mental health first aid to children aged 5-12 years
The linked study (ACTRN12625000788471) was a pilot study using a waitlist-controlled trial design among general Australian adults.
The current study is an uncontrolled trial among CALD parents, with an additionally qualitative interview component.

Health condition
Health condition(s) studied:
Child mental health problems 342085 0
Child dangerously aggressive behaviours 342087 0
Child Mental Health self-harm or suicide 342088 0
Condition category
Condition code
Mental Health 338202 338202 0 0
Anxiety
Mental Health 338203 338203 0 0
Depression
Mental Health 338204 338204 0 0
Other mental health disorders
Mental Health 338205 338205 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Intervention name: Supporting Child Mental Health: A comprehensive program for teaching adults to learn how to provide mental health first aid to children aged 5-12 years.

What/Materials and procedures Intervention Content
The program covers the topics of: (i) Child mental health and mental health problems in childhood, (ii) How to provide mental health first aid to support a child who is developing a mental health problem (internalising or externalising problems), or a child who is experiencing a mental health crisis (dangerous aggression or being at risk of self-harm), (iii) levels of appropriate help for child mental health problems and crises, and (iv) a child’s support system and collaborating with responsible adults in a child’s life.
The guidebook, along with the accompanying eLearning modules and live training sessions are designed to be a comprehensive program for adults to learn how to provide mental health first aid to support children aged 5-12 years, constituting 8-hours total training time.

Program Materials
The intervention is delivered across a blended format with 4-hours of self-paced eLearning and 4-hours of live group sessions provided by an experienced trained Instructor.

The eLearning modules are accessed through University of Melbourne’s Learning Management System (Canvas software; a digital web-enabled content management platform) and the live sessions are delivered by a trained Instructor according to a standardized presentation manual.

The intervention program also includes:
202-page guidebook, accessed as an electronic book through the LMS
Reflective Journal – 55 A4 pages of written activities for use during the eLearning and live sessions. Instructor Presentation Manual – 81 A4 pages
Viewing of short films produced specifically for this program.
A certificate of completion if requested for supporting professional development hours.

The guidebook, eLearning modules, and live training session are purpose-built for this study and are not publicly available resources.

Program Procedures
Participants are emailed a link from the LMS software and asked to register as a learner. Once they register, they are granted access to the SCMH eLearning online course as a participant.
The eLearning modules are structured as 8 sequential 30-minute lessons that each conclude with quiz constituting 5 multiple choice questions. Participants cannot move on to the next lesson in sequence until the prior lesson and associated quiz is completed. Upon completing all 8 lessons, participants are provided with a link to an online survey which confirms their enrolment in the second training component - the live group session delivery.
For the live sessions, a trained Instructor provides 4 sessions each of 1 hour length to groups of between 6- 12 participants.

Who/Intervention providers
There are currently 8 trained instructors who can deliver the SCMH Intervention across Australia. Instructors are selected based on their knowledge of child mental health, parenting and/or primary school education setting. All instructors have professional qualifications in mental health, including as clinical psychologists, school counsellors, mental health nurses or crisis help line counsellors.
Before being authorised to deliver the intervention, instructors must undertake the 8-hour SCMH training program, then receive 10 additional hours of training via virtual ‘Communities of Practice’ 5x 2-hour group sessions, facilitated by the program authors and research team. In one of these sessions the training Instructor must present one of the live group sessions to the trainee Instructor group, to be considered competent to deliver the intervention to trial participants.

How/Mode of delivery
The eLearning modules are delivered as a digital online self-paced resource hosted by the University of Melbourne learning management system - CANVAS. The live sessions can be delivered either face-to- face in a classroom setting, or virtually via videoconferencing (e.g. Zoom or MS Teams).

When/Number of times, duration, intensity, or dose
Blended delivery with 8 modules (4-hours) self-paced eLearning and 4 sessions (4 hours) of live group sessions provided by a trained Instructor, according to a structured facilitation manual.
Participants must complete at least one eLearning module before attending the live sessions. Participants are encouraged to complete as many eLearning modules as possible before attending the live sessions and email and sms reminders are sent for this purposes. However, not all 8 lessons need to be completed prior to attending the live sessions. Dosage of eLearning modules is recorded prior to attendance at live sessions.
The live sessions can be delivered as 4x sessions on 1x day, 2x sessions across 2x days or 1x session across 4 days. The structure of the live sessions will depend on the preference and availability of the training group.
Participants must complete the live sessions in the same standard sequence. If one session is missed, participants are not allowed to progress onto the next session until the missed session is completed. This may require participants to move from one training group to another, but never from intervention to waitlist arm, nor vice versa. Dosage of live sessions is recorded via an attendance list completed by the Instructor. Participants are expected to complete all components of the intervention within a minimum of 2-3 weeks and a maximum of 8 weeks.

How well/Fidelity measurement
eLearning modules are always accessed in the same standard sequence and deviations in sequence are not possible and therefore not assessed.
Fidelity of live session delivery will be measured using a program content check-list, derived from the structured presentation manual used by Instructors. Fidelity check-lists will be completed by a research staff member viewing live group sessions, or where this is not possible, by the Instructor after the delivery of each of the 4 sessions.
Intervention code [1] 334215 0
Early detection / Screening
Description of the comparator or control
No active control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345572 0
Score of mental health literacy in supporting children
Timepoint [1] 345572 0
Pre-training (before starting eLearning modules), post-training (after completing the live group training sessions) and 3-months follow-up (3 months after completing the live group training sessions)
Primary outcome [2] 345576 0
Score of the Mental Health Support Scale for Adults Helping Children
Timepoint [2] 345576 0
Pre-training (before starting eLearning modules), post-training (after completing the live group training sessions) and 3-months follow-up (3 months after completing the live group training sessions)
Secondary outcome [1] 462242 0
Score on stigmatizing attitudes towards children with mental health problems
Timepoint [1] 462242 0
Pre-training (before starting eLearning modules), post-training (after completing the live group training sessions) and 3-months follow-up (3 months after completing the live group training sessions)
Secondary outcome [2] 462243 0
Score of empathy towards children with mental health problems
Timepoint [2] 462243 0
Pre-training (before starting eLearning modules), post-training (after completing the live group training sessions) and 3-months follow-up (3 months after completing the live group training sessions)
Secondary outcome [3] 462870 0
Score of confidence in providing support
Timepoint [3] 462870 0
Pre-training (before starting eLearning modules), post-training (after completing the live group training sessions) and 3-months follow-up (3 months after completing the live group training sessions)
Secondary outcome [4] 462895 0
Cultural relevance, safety and acceptance, which were assessed as a composite outcome
Timepoint [4] 462895 0
3-months after the live group training sessions

Eligibility
Key inclusion criteria
The target participants for this project are parents and other caregivers of primary school-aged children from CALD backgrounds.

To be eligible, parent/carers will be required to:
• Be living with children aged 5-12
• Speak a language other than English at home
• Sufficient English proficiency to complete online surveys
• Be aged 18 years or older
• Be able to complete three 20-minute online surveys, and consent to complete 4-hours of online modules and 4-hours of instructor-led, live training sessions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
The following people are not eligible to take part in this study, as we are seeking individuals who have not undertaken recent or extensive prior training in mental health:
• Mental health professionals including school counsellors, education and developmental psychologists, school psychologists, licensed clinical social workers or mental health occupational therapists
• Mental Health and Wellbeing Leaders (MHWL) within schools
• Any adult who has undertaken Mental Health First Aid™ training, or any other similar mental health training, in the past 24 months (including those who have been or are currently, a MHFA Instructor).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
20/10/2025
Date of last participant enrolment
Anticipated
Actual
20/12/2025
Date of last data collection
Anticipated
Actual
23/05/2026
Sample size
Target
30
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 321802 0
Charities/Societies/Foundations
Name [1] 321802 0
Australian Rotary Health
Country [1] 321802 0
Australia
Funding source category [2] 322002 0
Charities/Societies/Foundations
Name [2] 322002 0
Mental Health First Aid International Ltd
Country [2] 322002 0
Australia
Primary sponsor type
Individual
Name
Dr Shurong Lu, University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 324653 0
Individual
Name [1] 324653 0
Associate Professor Laura Hart, University of Melbourne
Address [1] 324653 0
Country [1] 324653 0
Australia
Secondary sponsor category [2] 324876 0
Individual
Name [2] 324876 0
Associate Professor Amy Morgan, University of Melbourne
Address [2] 324876 0
Country [2] 324876 0
Australia
Secondary sponsor category [3] 324877 0
Individual
Name [3] 324877 0
Emeritus Professor Anthony Jorm, University of Melbourne
Address [3] 324877 0
Country [3] 324877 0
Australia
Secondary sponsor category [4] 324878 0
University
Name [4] 324878 0
Ms Karen Gregg, University of Melbourne
Address [4] 324878 0
Country [4] 324878 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320347 0
University of Melbourne Human Research Ethics Committee STEMM 3
Ethics committee address [1] 320347 0
Ethics committee country [1] 320347 0
Australia
Date submitted for ethics approval [1] 320347 0
26/06/2025
Approval date [1] 320347 0
16/10/2025
Ethics approval number [1] 320347 0
2025-32993-72312-5

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 150170 0
Dr Shurong Lu
Address 150170 0
207 Bouverie Street, Parkville, VIC 3010, The University of Melbourne
Country 150170 0
Australia
Phone 150170 0
+61 3 8344 5642
Fax 150170 0
Email 150170 0
[email protected]
Contact person for public queries
Name 150171 0
Shurong Lu
Address 150171 0
207 Bouverie Street, Parkville, VIC 3010, The University of Melbourne
Country 150171 0
Australia
Phone 150171 0
+61 3 8344 5642
Fax 150171 0
Email 150171 0
[email protected]
Contact person for scientific queries
Name 150172 0
Shurong Lu
Address 150172 0
207 Bouverie Street, Parkville, VIC 3010, The University of Melbourne
Country 150172 0
Australia
Phone 150172 0
+61 3 8344 5642
Fax 150172 0
Email 150172 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: In accordance with ethical requirements, results will be reported only in aggregate form, and no individual participant information will be shared with any third parties. Any participant quotations will be presented anonymously, with all identifying information removed.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Letter 20251016.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.