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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000139370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
15/01/2026
Date registered
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4/02/2026
Date last updated
Help: Date last updated
4/02/2026
Date data sharing statement initially provided
Help: Data sharing statement date
4/02/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Prevention in primary schools: Increasing support and training in child anxiety to primary school educators
Scientific title
Prevention in primary schools: Increasing support and training in child anxiety to primary school educators
Additional trial identifiers [1] 316112 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Anxiety 340011 0
Condition category
Condition code
Mental Health 336220 336220 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a randomised controlled trial with two arms: Arm 1 will receive a training program and Arm 2 will be a training-as-usual control group, who will receive the training program following the Arm 1 group completing their assessments.

The training program is an online educational program for primary school teachers. The training program aims to improve teachers' knowledge, confidence, and behavioural practices with their students who exhibit symptoms of anxiety. The training program comprises two self-paced online modules (approximately 1 hour each) and two group workshops (approximately 2.5 hours each) facilitated by trained psychologists.

The content of the online modules contains psychoeducation on child anxiety, strategies to identify and support student anxiety, role plays on talking to students and parents about anxiety, and psychoeducation on the teachers' own mental health. The mode of training used in the online modules includes online videos, text, and graphics.

The time to complete the entire training program is likely to span 2-3 months or 1 school term, depending on participants' availability for the group workshops.

The training program is standardised and will not be adapted to individuals or groups of individuals in the Arm 1 group.

Training program adherence will be assessed through completion data collected through the training program, e.g. timestamps of starting and completing the two self-paced online modules (including timestamps and length of time in minutes spent on each page/section of the module), and attendance at the two group workshops.
Intervention code [1] 332721 0
Other interventions
Description of the comparator or control
The active control includes a training-as-usual control group (Arm 2) will include teachers who can participate in other training programs if desired (to reflect real world scenarios, e.g., if teachers choose to participate in professional development training programs on anxiety, or self-help courses for their own personal interest) while Arm 1 receives the training program. The Arm 2 group will receive the training program following the Arm 1 group completing their assessments (i.e., after T3).
Control group
Active

Outcomes
Primary outcome [1] 343775 0
Teacher-reported anxiety-related literacy
Timepoint [1] 343775 0
For Arm 1, assessments will occur at three timepoints: T1 = pre-training, T2 = post-training (primary endpoint), and T3 = 1-month follow-up. For Arm 2, assessments will occur at four timepoints: T1, T2, and T3 at the same timepoints as the Arm 1 group, then they will receive the training program, followed by T4 = post-training (Arm 2 only) to enable within-group analyses for Arm 2.
Secondary outcome [1] 455570 0
Teachers’ anxiety-related self-efficacy
Timepoint [1] 455570 0
For Arm 1, assessments will occur at three timepoints: T1 = pre-training, T2 = post-training, and T3 = 1-month follow-up. For Arm 2, assessments will occur at four timepoints: T1, T2, and T3 at the same timepoints as the Arm 1 group, then they will receive the training program, followed by T4 = post-training (Arm 2 only) to enable within-group analyses for the Arm 2 group.
Secondary outcome [2] 455571 0
Teachers' behavioural practices when identifying or supporting students with anxiety
Timepoint [2] 455571 0
For Arm 1, assessments will occur at three timepoints: T1 = pre-training, T2 = post-training, and T3 = 1-month follow-up. For Arm 2, assessments will occur at four timepoints: T1, T2, and T3 at the same timepoints as the Arm 1 group, then they will receive the training program, followed by T4 = post-training (Arm 2 only) to enable within-group analyses for Arm 2.
Secondary outcome [3] 455572 0
Teachers' anxiety-related stigma
Timepoint [3] 455572 0
For Arm 1, assessments will occur at three timepoints: T1 = pre-training, T2 = post-training, and T3 = 1-month follow-up. For Arm 2, assessments will occur at four timepoints: T1, T2, and T3 at the same timepoints as Arm 1, then they will receive the training program, followed by T4 = post-training (Arm 2 only) to enable within-group analyses for Arm 2.
Secondary outcome [4] 455573 0
Exploratory analyses will examine teachers' perceptions of the training program's acceptability
Timepoint [4] 455573 0
Participants will receive this acceptability question in surveys following their receipt of the training program. Therefore, participants in Arm 1 will receive these questions at T2 and T3, and participants in Arm 2 will receive these questions at T4.
Secondary outcome [5] 455574 0
Exploratory analyses will examine teachers' own symptoms of anxiety
Timepoint [5] 455574 0
For Arm 1, assessments will occur at three timepoints: T1 = pre-training, T2 = post-training, and T3 = 1-month follow-up. For Arm 2, assessments will occur at four timepoints: T1, T2, and T3 at the same timepoints as the Arm 1 group, then they will receive the training program, followed by T4 = post-training (Arm 2 only) to enable within-group analyses for Arm 2.
Secondary outcome [6] 456942 0
Exploratory analyses will examine teachers' perceptions of the training program's feasibility.
Timepoint [6] 456942 0
Participants will receive these questions in surveys following their receipt of the training program. Therefore, participants in Arm 1 will receive these questions at T2 and T3, and participants in Arm 2 will receive these questions at T4.

Eligibility
Key inclusion criteria
A current primary school teacher in Australia (or, if teaching in a K-12 school, currently teaching primary school ages i.e., years K-6)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
• Participated in the pilot study for this teacher training program
• Provided lived experience advice on the teacher training program

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be conducted by an independent statistician (Prof Andrew Mackinnon), ensuring researchers and participants will be blinded to allocation at the time of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting participants will be randomly allocated to either Arm 1 (receiving the teacher training program) or Arm 2 (training-as-usual control) condition, with an allocation ratio of 1:1. Randomisation will be stratified by state/territory, type of school (Government, independent, and Catholic), and location (metropolitan, regional/rural, and remote/very remote, as per the Modified Monash Model). Using contingent allocation, the first teacher from a school will be randomly allocated, and any subsequent recruitment of teachers from that same school will be assigned to the same condition to avoid data contamination.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will recruit 232 primary school teachers. Allowing for 50% attrition, the final sample of 116 teachers (58 in each Arm) will provide 80% power to detect a medium-to-large effect size (d = 0.7), assuming a 0.05 Intraclass Correlation Coefficient between teachers in the same workshop (assuming 15 per workshop).

The study will utilise a parallel longitudinal cluster superiority RCT to evaluate whether outcomes for Arm 1 (the group that receives the training program) is superior to Arm 2 (the training-as-usual control group where teachers can participate in other training programs if desired). For Arm 1, assessments will occur at three timepoints: T1 = pre-training, T2 = post-training (primary endpoint), and T3 = 1-month follow-up. For Arm 2, assessments will occur at four timepoints: T1, T2, and T3 at the same timepoints as the Arm 1 group, then they will receive the training program, followed by T4 = post-training (Arm 2 only) to enable within-group analyses for Arm 2. Primary outcome will be teacher-reported anxiety-related literacy. Secondary outcomes include: teachers’ anxiety-related self-efficacy, behavioural practices when identifying or supporting students with anxiety, and anxiety-related stigma. Exploratory analyses will examine feasibility of the training program and teachers' own symptoms of anxiety. This design will provide robust evidence on the program’s effectiveness in improving child anxiety and its potential for scalable implementation in school settings.

To assess the quantitative primary and secondary outcomes of the RCT, we will use a mixed-model repeated measures (MMRM) approach, with time as the within-group factor (for arm 1: T1, T2, and T3; for Arm 2: T1, T2, T3, and T4) and condition as the between-group factor (Arm 1 vs. Arm 2). This approach handles missing data by including all available data from each subject into the analysis and assumes missing data are missing at random. The primary analysis will be conducted using planned contrasts comparing change in teacher scores on variables of interest from T1 to T3 between the trial arms (Arm 1 vs. Arm 2). School will be included as a random effect to evaluate and accommodate clustering effects. Variables used in determining condition allocation balance will be evaluated and retained in analyses where significant. An unconstrained variance–covariance matrix will model within-individual dependencies. The maintenance of training effects will be evaluated by testing within-group change (from T1 to T3 for Arm 1 and from T1 to T4 for Arm 2).

Qualitative data will be assessed through thematic content analysis to categorise free-text responses. Qualitative data will be systematically and independently analysed by at least two researchers, with discrepancies resolved by discussion. If consensus is unable to be achieved, a third researcher on the team will be consulted for final decision.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/02/2026
Actual
Date of last participant enrolment
Anticipated
31/03/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
232
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 320710 0
University
Name [1] 320710 0
University of Sydney PREMISE Next Generation NHMRC Centre of Research Excellence in Prevention of Mental Illness and Substance Use
Country [1] 320710 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 323373 0
None
Name [1] 323373 0
None
Address [1] 323373 0
Country [1] 323373 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319248 0
The University of New South Wales Committee B
Ethics committee address [1] 319248 0
Ethics committee country [1] 319248 0
Australia
Date submitted for ethics approval [1] 319248 0
29/09/2025
Approval date [1] 319248 0
28/11/2025
Ethics approval number [1] 319248 0
iRECS9534

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

Contacts
Principal investigator
Name 146750 0
Prof Jen Hudson
Address 146750 0
Black Dog Institute, The University of New South Wales, Hospital Road, Randwick, NSW, 2031
Country 146750 0
Australia
Phone 146750 0
+61408660098
Fax 146750 0
Email 146750 0
[email protected]
Contact person for public queries
Name 146751 0
Jen Hudson
Address 146751 0
Black Dog Institute, The University of New South Wales, Hospital Road, Randwick, NSW, 2031
Country 146751 0
Australia
Phone 146751 0
+61408660098
Fax 146751 0
Email 146751 0
[email protected]
Contact person for scientific queries
Name 146752 0
Jen Hudson
Address 146752 0
Black Dog Institute, The University of New South Wales, Hospital Road, Randwick, NSW, 2031
Country 146752 0
Australia
Phone 146752 0
+61408660098
Fax 146752 0
Email 146752 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 approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
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 data collection is completed

To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: The data custodian for this data is Prof Jennie Hudson, contactable at [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: The data custodian will ensure that the data will only be shared using one UNSW Supported Platform.



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.