Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000788471
Ethics application status
Approved
Date submitted
26/06/2025
Date registered
25/07/2025
Date last updated
25/07/2025
Date data sharing statement initially provided
25/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting Child Mental Health: An evaluation of a new training program for adults providing mental health first aid to children aged 5-12 years
Scientific title
Supporting Child Mental Health: Evaluating the safety and feasibility of a new training program for adults providing mental health first aid to children aged 5-12 years
Secondary ID [1] 314756 0
None
Universal Trial Number (UTN)
Trial acronym
SCMH Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adults’ mental health literacy for supporting children 337972 0
Childhood development or experience of mental health problems or mental health crises 338119 0
Help seeking for child mental health problems or mental health crisis 338120 0
Condition category
Condition code
Public Health 334288 334288 0 0
Health promotion/education
Mental Health 334526 334526 0 0
Anxiety
Mental Health 334527 334527 0 0
Depression
Mental Health 334528 334528 0 0
Autistic spectrum disorders
Mental Health 334529 334529 0 0
Eating disorders
Mental Health 334530 334530 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supporting Child Mental Health (SCMH) is a new training program for educators and parents/carers of primary school aged children about how adults can best support 5 to 12 year olds with current or emerging mental health problems. The SCMH course aims to increase adults' mental health literacy and the first aid skills required to support a child who (1) is developing a mental health problem (2) has experienced an adversity or traumatic event that places them at increases risk of poor mental health, or (3) is in a mental health crisis. The first aid is given until appropriate help is received.

The course teaches an action plan to provide mental health first aid to support children and addresses the following-:
Adults’ knowledge and beliefs that support action to prevent or manage mental health problems in children
How to recognise when a child is developing a mental health problem (e.g., not coping, experiencing increasing distress, or difficulty functioning as expected)
The knowledge and attitudes about how to seek and engage critically with information about child mental health
Risk factors and causes of mental health prob­lems in children
Sources of formal and informal help for both the child and caregivers
The ability to communicate about child mental health and supportive strategies with the child in a develop­mentally­ appropriate manner, and with other adults who care for or are responsible for the child

The SCMH program involves participants completing 8 self-led online eLearning modules (totalling 4 hours in length and expected to be completed within 1-3 weeks), The eLearning is followed by 4 hours of live Instructor led content (delivered to groups either by video-conferencing or in-person). The 4 x 1 hour sessions may be delivered on one day, or over one to two weeks as 4 x 1-hour or 2 x 2-hour on separate days depending on the preference and availability of schools/organisations and individual participants involved.
The eLearning modules incorporate films, activities and quizzes designed to build knowledge and attitudes that support seeking early and appropriate help for child mental health problems. The live instructor-led sessions incorporates case studies and scenario role plays to develop skills in using the program action plan to provide appropriate support for child mental health. Educators and parents/carers undertake the same eLearning modules. However, the live sessions will be delivered to groups of parent/carers and educators separately. Participants who are undertaking the SCMH program in a professional capacity as educators will receive the live-sessions as a group of colleagues at their employing school or in combination with staff from other local schools who have also agreed to host the research. parent/carers groups will either be held face-to-face on school grounds, or via zoom. Parent/carer groups will mostly consist of participants recruited from a single school community, except where school communities are small and the uptake of parents is not large enough to make a feasible live group (i.e., less than 6), in which case, parents/carers from other local schools will be pooled into groups to make delivery maximally engaging for the attendees and feasible for the research team. Live groups will be capped at a maximum of 12 for zoom delivery and 20 for in person delivery. Participant learning throughout the eLearn and Instructor live sessions will be supported by a Guidebook and Reflective journal.

Participant progression through the eLearn will be reliant their completion of each of the 8 modules in succession and participants attendance at the Instructor live sessions will be reliant on their completion of at least 4 of the elearn modules. Participants will be encouraged to return to complete any unfinished modules after the live sessions. Attendance at live sessions will be recorded and absentees encouraged to attend another delivery of the content. Actual eLearn completion and attendance at Instructor Live sessions will be tracked and added to participant survey data for analysis.

All components of the SCMH program have been developed by the program authors with references to scientific articles cited in the program materials. One short video, used in the eLearn is available to the public via YouTube https://www.youtube.com/watch?v=fcNhpjka5Vk The USA developers have given their approval for its use and provided a copy of the video to the authors that has been uploaded to the University Learning Management system hosting the SCMH eLearn.
Intervention code [1] 331357 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341953 0
Mental Health Literacy
Timepoint [1] 341953 0
The Primary outcome {1} will be measured at baseline (before training begins), Post eLearning (after the elearning), Post Instructor live sessions (after the Post Instructor live sessions) and follow-up (4 weeks after training).
Primary outcome [2] 341954 0
Quality of mental health first aid actions
Timepoint [2] 341954 0
The Primary outcome {2} will be measured at baseline (before training begins), Post eLearning (after the elearning), Post Instructor live sessions (after the Post Instructor live sessions) and follow-up (4 weeks after training).
Primary outcome [3] 342118 0
Child mental health stigma
Timepoint [3] 342118 0
The Primary outcome {3} will be measured at baseline (before training begins), Post Instructor live sessions (after the Instructor live sessions) and follow-up (4-weeks after training).
Secondary outcome [1] 449129 0
Experiences of providing mental health for aid for supporting children
Timepoint [1] 449129 0
The Secondary outcome {1} will be measured at baseline (a week before training begins) and follow-up (4 weeks after training).
Secondary outcome [2] 449131 0
Program Feedback
Timepoint [2] 449131 0
The Primary outcome {2} will be measured at Post eLearning (after the elearning), Post Instructor live sessions (after the Post Instructor live sessions) and follow-up (4 weeks after training).
Secondary outcome [3] 449132 0
Distress
Timepoint [3] 449132 0
The Secondary outcome {3} will be measured at baseline (before training begins), Post Instructor live sessions (after the Post Instructor live sessions) and follow-up (4 weeks after training).
Secondary outcome [4] 449133 0
Check for distress due to survey completion and participation in the SCMH program
Timepoint [4] 449133 0
The Secondary outcome {4} will be measured at baseline (before training begins), Post eLearning ( after the elearning), Post Instructor live sessions (after the Post Instructor live sessions) and follow-up (4 weeks after training).

Eligibility
Key inclusion criteria
• Parents/carers and educators who are living or working with children aged 5-12 years Educators include anyone who is involved in teaching children in a school setting, at a sports club, tutoring in the arts, or any other community activities such as volunteering or religious education. Parent/caregivers include any guardian or carer with responsibility for supporting a child’s mental health outside of an employment position (i.e., grandparent, adult family member, foster carer etc).
• Aged 18 years or older
• Able to read and write in the English language sufficient for survey completion
• Willing to complete 4-hours of eLearning modules
• Willing to complete 4-hours of instructor-led, live group training sessions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• 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
Safety/efficacy
Statistical methods / analysis
Data analysis for this study will include descriptive statistics and significance testing for change in scores over time.
The hypotheses will be analysed using mixed models for continuous and binary outcome variables.

These methods account for the correlation within educator and parent/carer responses over time.
To inform a future RCT, we will calculate intraclass correlation coefficients and effect sizes (Cohen’s d). Qualitative data analysis of open-ended responses will involve thematic and content analysis as per methods outlined by Braun & Clarke [1], and our previous evaluations of MHFA training [2, 3].

[1] Braun, V, et al. The online survey as a qualitative research tool, International Journal of Social Research Methodology, (2021) DOI: 10.1080/13645579.2020.1805550
[2] Johnson, CJ, et al. Lessons learnt from the field: a qualitative evaluation of adolescent experiences of a universal mental health education program. Health Education Research, 2021, DOI:10.1093/her/cyaa050
[3] Jorm, AF, et al. Experiences in applying skills learned in a mental health first aid training course: a qualitative study of participants' stories. BMC Psychiatry, (2005) DOI: 10.1186/1471-244X-5-43

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319306 0
Government body
Name [1] 319306 0
National Health and Medical Research Council
Country [1] 319306 0
Australia
Funding source category [2] 319307 0
Government body
Name [2] 319307 0
Medical Research Future Fund (MRFF)
Country [2] 319307 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 321783 0
None
Name [1] 321783 0
Address [1] 321783 0
Country [1] 321783 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317885 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 317885 0
Ethics committee country [1] 317885 0
Australia
Date submitted for ethics approval [1] 317885 0
12/05/2023
Approval date [1] 317885 0
15/08/2023
Ethics approval number [1] 317885 0

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

Contacts
Principal investigator
Name 142466 0
A/Prof Laura Hart
Address 142466 0
Equity and Mental Health Research Group Centre for Health Equity Melbourne School of Population and Global Health Level 5, 207 Bouverie Street, Carlton The University of Melbourne, Vic 3010
Country 142466 0
Australia
Phone 142466 0
+61 390356515
Fax 142466 0
Email 142466 0
[email protected]
Contact person for public queries
Name 142467 0
Karen Gregg
Address 142467 0
Equity and Mental Health Research Group Centre for Health Equity Melbourne School of Population and Global Health Level 5, 207 Bouverie Street, Carlton The University of Melbourne, Vic 3010
Country 142467 0
Australia
Phone 142467 0
+61 390356515
Fax 142467 0
Email 142467 0
[email protected]
Contact person for scientific queries
Name 142468 0
Laura Hart
Address 142468 0
Equity and Mental Health Research Group Centre for Health Equity Melbourne School of Population and Global Health Level 5, 207 Bouverie Street, Carlton The University of Melbourne, Vic 3010
Country 142468 0
Australia
Phone 142468 0
+61 390356515
Fax 142468 0
Email 142468 0
[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 review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• 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:
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
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: To Associate Professor Laura Hart at [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.