Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000343303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/02/2026
Date registered
Help: Date registered
19/03/2026
Date last updated
Help: Date last updated
19/03/2026
Date data sharing statement initially provided
Help: Data sharing statement date
19/03/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting childhood mental health in disasters: Evaluation of Psychological First Aid in Schools
Scientific title
Psychological First Aid in Schools to prepare staff for supporting student mental health in disasters and critical incidents: a cluster-randomised controlled trial
Additional trial identifiers [1] 314691 0
MRF2036034
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Psychological distress 337865 0
Mental health 337866 0
Trauma 337867 0
Condition category
Condition code
Mental Health 334194 334194 0 0
Other mental health disorders
Mental Health 334195 334195 0 0
Depression
Mental Health 334196 334196 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Name: Psychological First Aid in Schools (PFA-S)
Goal: The aim of PFA-S is to equip school staff with the knowledge, skills, and attitudes to be prepared to support the psychological wellbeing of school students when a disaster or critical incident occurs.
What: The PFA-S program of training is delivered over 2 hours, and includes education content regarding the impacts of disasters on children across development, PFA-S core principles and actions, examples of disasters and application of PFA-S actions, and opportunities to reflect on and apply PFA-S principles and actions to relevant disaster and school contexts. The materials used are designed specifically for this study, by members of the research team and the NSW Department of Education. Further information about training materials can be gained by contacting the researchers or the training providers.
Who: PFA-S training will be delivered by two NSW Department of Education Psychology and Wellbeing Services staff per session. Lead facilitators will be Psychologists in current wellbeing training and leadership roles and/or working in school psychologist roles.
How: The program will be delivered live to entire school staff groups. To meet the timetabling needs of each school, the program may be delivered in one 2-hour block, or in two 1 hour sessions across two weeks, with one session conducted online, and one session in-person. Strategies to monitor fidelity will include a fidelity checklist completed by facilitators, as well as session attendance records.
Where: The program will be delivered at each participating school site. School's completing the training across two weeks will access live facilitation for the first session via videoconferencing facilities, and the second session will be delivered on site.
Intervention code [1] 331296 0
Prevention
Description of the comparator or control
Wait-list control. During the intervention period, wait-list control condition schools will continue usual classroom activities, have access to usual wellbeing supports, and complete all surveys. Staff in the wait list control condition will receive the PFA training program following the completion of the final (4-month follow-up) survey.
Control group
Active

Outcomes
Primary outcome [1] 341871 0
Psychological First Aid Preparedness (knowledge, attitudes, and skills), assessed as a composite primary outcome.
Timepoint [1] 341871 0
Baseline, 1 month post-baseline (primary timepoint), 4 months post-baseline
Secondary outcome [1] 451882 0
Psychological preparedness
Timepoint [1] 451882 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [2] 457513 0
Disaster exposure (predictor/moderator). Assessed as a composite outcome.
Timepoint [2] 457513 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [3] 457514 0
General self-efficacy
Timepoint [3] 457514 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [4] 457515 0
Mental health literacy
Timepoint [4] 457515 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [5] 457516 0
Wellbeing
Timepoint [5] 457516 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [6] 457517 0
Psychological distress
Timepoint [6] 457517 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [7] 457518 0
School identification
Timepoint [7] 457518 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [8] 457519 0
Student-staff relations
Timepoint [8] 457519 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [9] 457520 0
Actual use of PFA-S
Timepoint [9] 457520 0
1 month post-baseline, 4 months post-baseline
Secondary outcome [10] 457521 0
Staff ongoing development
Timepoint [10] 457521 0
1 month post-baseline, 4 months post-baseline.
Secondary outcome [11] 457524 0
Student School identification
Timepoint [11] 457524 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [12] 457525 0
Trusted adults at school
Timepoint [12] 457525 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [13] 457526 0
Help-seeking ease
Timepoint [13] 457526 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [14] 457529 0
Student Psychological preparedness
Timepoint [14] 457529 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [15] 457531 0
Student Wellbeing
Timepoint [15] 457531 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [16] 457532 0
Student Depression
Timepoint [16] 457532 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [17] 457533 0
Student Anxiety
Timepoint [17] 457533 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [18] 457534 0
PFA-S experience
Timepoint [18] 457534 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [19] 457535 0
PFA-S interest
Timepoint [19] 457535 0
1 month post-baseline, 4 months post-baseline
Secondary outcome [20] 457536 0
Disaster preparedness education needs
Timepoint [20] 457536 0
1 month post-baseline, 4 months post-baseline
Secondary outcome [21] 457540 0
Fidelity of training delivery
Timepoint [21] 457540 0
Post-intervention delivery
Secondary outcome [22] 457541 0
Staff acceptability and satisfaction assessed as a composite outcome.
Timepoint [22] 457541 0
Post-intervention
Secondary outcome [23] 457543 0
Staff perceptions of implementation leadership
Timepoint [23] 457543 0
Post-intervention
Secondary outcome [24] 457551 0
Staff Whole-school mental health promotion
Timepoint [24] 457551 0
Post-intervention
Secondary outcome [25] 457552 0
School context factors influencing implementation.
Timepoint [25] 457552 0
Post-intervention
Secondary outcome [26] 457553 0
Staff Interviews to explore acceptability and satisfaction of PFA-S, and perceived barriers and facilitators to using PFA-S, assessed qualitatively as a composite outcome.
Timepoint [26] 457553 0
4-month follow-up
Secondary outcome [27] 457554 0
Student Focus Groups to explore student experiences of PFA-S supports and principles and current gaps and needs for student disaster mental health supports, assessed qualitatively as a composite outcome.
Timepoint [27] 457554 0
4-month follow up
Secondary outcome [28] 458587 0
Leadership at school
Timepoint [28] 458587 0
Baseline, 1 month post-baseline, 4 months post-baseline
Secondary outcome [29] 458588 0
Help-seeking intentions
Timepoint [29] 458588 0
Baseline, 1 month post-baseline, 4 months post-baseline

Eligibility
Key inclusion criteria
The current project is a universal trial, meaning all staff (wellbeing, teaching and support staff) within a participating school will be invited to participate in the trial. All students at participating schools aged >= 8 years will be eligible to assent to survey participation, with parent/carer consent, if they can complete the survey with usual classroom supports in place, All students at participating schools aged >= 5 years will be eligible to assent to focus group participation, with parent/carer consent.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
No exclusion criteria; however, participants must meet the inclusion criteria and provide assent and parental consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Students between 8- and 18-years-old at participating schools will be invited to participate in the trial. Participating year levels will be determined by individual schools.

Cluster randomisation (by individual school) will be employed for administrative convenience, and to avoid control condition contamination. Randomisation will be carried out by an off-site researcher not involved in the day-to-day conduct of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Due to the number of schools, a minimisation approach will be used to ensure balance across conditions on the basis of school type (high school/primary school), number of students and gender balance. This approach allocates schools to conditions on the basis of selecting the condition that results in the least imbalance, while incorporating a random process to ensure that allocation cannot be predicted in advance.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative analyses will follow an intent-to-treat approach, including all participants randomised, regardless of adherence to the intervention or withdrawal from the study. For continuous variables, mixed-model repeated measures (MMRM) analyses will be used. MMRM accommodates missing data without relying on biased techniques, such as last observation carried forward. By incorporating random effects for each school, MMRM also accounts for clustering and allows assessment of the strength and significance of clustering effects. This method is widely regarded as the most robust approach for analysing cluster randomised trials (Lane, 2008; Siddiqui, 2001). Dichotomous variables will be analysed using binary mixed models, which are analogous to linear MMRM. Sensitivity, subgroup and exploratory analyses will be conducted to explore potential mediators and moderators of training effectiveness, such as school culture, individual mental health, disaster experience, and demographic characteristics (e.g., age, gender).
Qualitative data from staff interviews and student focus groups will be analysed using Framework Analysis. This systematic approach involves either inductive or deductive coding and the development of a matrix of themes across participants, facilitating collaborative interpretation and analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2026
Actual
Date of last participant enrolment
Anticipated
1/08/2027
Actual
Date of last data collection
Anticipated
17/12/2027
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319240 0
Government body
Name [1] 319240 0
Department of Health, Disability and Ageing -Medical Research Futures Fund (MRFF) Childhood Mental Health Research Grant (MRF2036034).
Country [1] 319240 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
Country
Australia
Secondary sponsor category [1] 323806 0
None
Name [1] 323806 0
Address [1] 323806 0
Country [1] 323806 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317818 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 317818 0
Ethics committee country [1] 317818 0
Australia
Date submitted for ethics approval [1] 317818 0
04/04/2025
Approval date [1] 317818 0
25/05/2025
Ethics approval number [1] 317818 0
2025 0018

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

Contacts
Principal investigator
Name 142254 0
Dr Emily Macleod
Address 142254 0
Centre for Mental Health Research, Australian National University, 63 Eggleston Rd, Acton, ACT, 2601
Country 142254 0
Australia
Phone 142254 0
+61 481957569
Fax 142254 0
Email 142254 0
[email protected]
Contact person for public queries
Name 142255 0
Emily Macleod
Address 142255 0
Centre for Mental Health Research, Australian National University, 63 Eggleston Rd, Acton, ACT, 2601
Country 142255 0
Australia
Phone 142255 0
+61 481957569
Fax 142255 0
Email 142255 0
[email protected]
Contact person for scientific queries
Name 142256 0
Emily Macleod
Address 142256 0
Centre for Mental Health Research, Australian National University, 63 Eggleston Rd, Acton, ACT, 2601
Country 142256 0
Australia
Phone 142256 0
+61 481957569
Fax 142256 0
Email 142256 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
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?
• 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:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Requests for access to data and for each purpose, will be on a case-by-case basis by the Principal Investigator and data safety management team. We do not intend to make the line by line data public. However, deidentified data will be shared upon reasonable request to the Principal Investigator. Data shared will be limited to individual participant data of primary and secondary outcomes, and general demographic information that would not lead to identification of students (e.g., age, school location).



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.