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Trial registered on ANZCTR


Registration number
ACTRN12623001108606
Ethics application status
Approved
Date submitted
21/09/2023
Date registered
24/10/2023
Date last updated
20/05/2024
Date data sharing statement initially provided
24/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Effect of a Psychological Safety Program on Help-Seeking and Well-Being in Primary School Students: A Randomised Controlled Trial
Scientific title
Evaluating the Effect of a Psychological Safety Program on Help-Seeking and Well-Being in Primary School Students: A Randomised Controlled Trial
Secondary ID [1] 310214 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological safety 330893 0
Help-seeking behaviours 330894 0
General psychological distress 330895 0
Condition category
Condition code
Mental Health 327683 327683 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 328518 328518 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Let’sTALK Program is a school-based intervention targeting mental health literacy and stigma to improve psychological safety. In other words, the goal is to create a positive environment where students feel safe in talking about their mental health problems with peers and trusted adults and to seek help before these escalate into more serious issues.

The Let'sTALK Program was developed and will be delivered in participating Victorian primary schools by the CCC Foundation Australia Inc. The CCC Foundation Australia Inc. has had over 5 years of experience in delivering this program.

About the Let'sTALK Program:
A group of individuals receive a face-to-face training session at the beginning of the school term on how to use the TALK framework to improve psychological safety in schools. Specifically, a Let’sTALK facilitator guides individuals through the Let’sTALK manual which outlines the application of the framework:
• Topic 1 (T): Tell when someone is in distress and engage in a conversation
o Introduction – purpose and vision of the Let’sTALK program
o Psychological safety – the foundation to wellbeing
o Mindfulness – to be aware of oneself, others, and the tell-tale signs of distress
o Stigma – to be aware of one’s biases and how it affects open communication
o Conversation – how to start a conversation with someone in distress, including oneself
• Topic 2 (A): Acknowledge the person and their concerns
o Vulnerability – how it is a strength and not a weakness
o Trust – the elements of trust that are critical for open communication
o Empathy – to step outside one’s experiences to understand others’
o Gratitude – to make difficult conversations easier for both parties
o Acknowledge – how a simple statement can validate the other person and build trust
• Topic 3 (L): Listen to help externalise the person’s concerns
o Listening – why it can be difficult at the best of times
o The 3 Fs – how facts, feelings, and fears can get to the bottom of a problem
o Emotional intelligence – how it impacts the quality of conversations
o Active listening – skills to say less and hear more
• Topic 4 (K): Keep in touch to support and empower the person
o The three stages of keeping in touch to support someone in distress
o Referring the person to source appropriate support (i.e., to resources and referral options appropriate for the Victorian education system)
o Classroom and school-wide activities to embed and sustain a culture of having open conversations
o Measures to monitor and assess the impact of The Let’sTALK Program on psychological safety and well-being

Within each school, up to 30 school staff (Let’sTALK Mentors) are selected to receive an 8-hour training session, and up to 30 students (Let’sTALK Buddies) are selected to receive a 4-hour training session. The content covered in this training session is the same for mentors and buddies. Mentors and buddies are also provided with 1-hour, monthly coaching/mentoring sessions throughout the year by the Let’sTALK facilitator to ensure program fidelity. These sessions are conducted in groups, with mentors and buddies coached/mentored separately. Both the training and coaching/mentoring sessions are conducted at the school.

Mentors and buddies 'apply' the intervention (i.e., increase the psychological safety in their school) by making themselves available and approachable by students to discuss any psychological difficulties during school hours. This is facilitated by having mentors and buddies wear a Let'sTALK shirt on top of their clothes/uniform. Students are also made aware of the role of mentors and buddies through a Let'sTALK launch event (i.e., announcement during school assembly) at the beginning of the school year.

To assess the effectiveness of the program, a randomised controlled trial design will be used. Ten participating primary schools will be randomly assigned to receive The Let'sTALK Program or be in the wait-list control condition. Participants in both conditions will be observed 5 times between January 30th, 2024, and December 20th, 2024 (11 months).
Intervention code [1] 326603 0
Behaviour
Comparator / control treatment
Wait-list control (no treatment given). Duration: between January 30th, 2024, and December 20th, 2024 (11 months).

Control group will be offered the intervention after the 11-month intervention period, at the start of the next school year (2025).
Control group
Active

Outcomes
Primary outcome [1] 335480 0
Student strengths and difficulties will be assessed using the Strengths and Difficulties Questionnaire - Youth Self-Report (SDQ-YSR).
Timepoint [1] 335480 0
Baseline, 3, 6, 9, and 11 months (primary timepoint) after beginning the intervention.
Primary outcome [2] 335481 0
Student well-being will be assessed using the Stirling Children's Well-Being Scale (SCWBS).
Timepoint [2] 335481 0
Baseline, 3, 6, 9, and 11 months (primary timepoint) after beginning the intervention.
Primary outcome [3] 335482 0
In-house measure will assess student help-seeking behaviours.

Questions on the measure (see below) are rated on a 5-point Likert scale (Strongly Disagree to Strongly Agree).
1. If I was feeling upset or scared, I would feel comfortable asking a teacher or adult for help.
2. If I was feeling upset or scared, I would feel comfortable asking another student or friend for help.
3. In the last month, when you were feeling upset or scared, how many times did you seek help from a teacher/adult/student/friend?
Timepoint [3] 335482 0
Baseline, 3, 6, 9, and 11 months (primary timepoint) after beginning the intervention.
Secondary outcome [1] 424787 0
Student psychological safety will be measured using the Psychological Safety Scale (PSS) and the in-house survey developed by the CCC Foundation Australia Inc. (Let'sTALK survey).
Timepoint [1] 424787 0
Baseline, 3, 6, 9, and 11 months (primary timepoint) after beginning the intervention.
Secondary outcome [2] 424788 0
In-house measure will assess the acceptability of The Let'sTALK Program as perceived by Let'sTALK Buddies.

Questions on the measure (see below) are rated on a 5-point Likert scale (Strongly Disagree to Strongly Agree).
1. The Let'sTALK training was easy for me to understand.
2. I found the Let'sTALK program helpful.
3. I learnt something new from the Let'sTALK program.
4. I am more confident in supporting other students and talking about my problems since completing the Let'sTALK program.
Timepoint [2] 424788 0
3, 6, 9, and 11 months (primary timepoint) after beginning the intervention.
Secondary outcome [3] 424789 0
Teacher psychological safety will be assessed using the People at Work Survey.
Timepoint [3] 424789 0
Baseline, 6, and 11 months (primary timepoint) after beginning the intervention.
Secondary outcome [4] 427924 0
Student strengths and difficulties will be assessed using the Strengths and Difficulties Questionnaire - Teacher Report (SDQ-TR). This is also a PRIMARY outcome.
Timepoint [4] 427924 0
Baseline, 3, 6, 9, and 11 months (primary timepoint) after beginning the intervention.

Eligibility
Key inclusion criteria
Teachers and students of participating Victorian primary schools. Computer and internet-literate.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
Schools will be randomly assigned to conditions using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To ensure fair measurement, cluster-randomization will be employed within each group to determine which individuals will provide data for the study. Specifically, one classroom, including the students and their teacher, will be randomly selected from Grades 3, 4, 5, and 6 in each school. This rigorous approach allows us to compare the effects of The Let’sTALK Program against the control group, providing valuable insights into its effectiveness in improving communication skills among students.
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
Primary outcomes of the study (Section 3.2. of research protocol) reported by students and teachers will be analysed using a 2-level mixed model repeated measures in SPSS with intervention as covariate at school level and class level as covariate at student level. Missing data will be handled using intention-to-treat.

Using G*Power (version 3.1.), a sample size of 156 participants was determined to be sufficient for a 90% chance of detecting a small effect (f = .10) across 5 measurement timepoints with an intraclass correlation of 0.5, and alpha set at .05 . This study will recruit a total of 190 participants given an expected attrition rate of 17% for longitudinal research in school-aged participants (n = 34).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/11/2023
Actual
2/02/2024
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
190
Accrual to date
372
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314378 0
University
Name [1] 314378 0
Swinburne University of Technology
Country [1] 314378 0
Australia
Funding source category [2] 314508 0
Charities/Societies/Foundations
Name [2] 314508 0
CCC Foundation Australia Inc.
Country [2] 314508 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
CCC Foundation Australia Inc.
Address
4 Rylandes DriveGladstone Park, VIC, 3043
Country
Australia
Secondary sponsor category [1] 316453 0
None
Name [1] 316453 0
Address [1] 316453 0
Country [1] 316453 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313471 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 313471 0
Swinburne University of TechnologyPO Box 218, Hawthorn, VIC, 3122
Ethics committee country [1] 313471 0
Australia
Date submitted for ethics approval [1] 313471 0
04/08/2023
Approval date [1] 313471 0
18/09/2023
Ethics approval number [1] 313471 0
20237392-16644

Summary
Brief summary
This project aims to evaluate the effectiveness of a school-based program (The Let’sTALK Program) in improving communication skills and promoting psychological safety in teachers and students. We hope to learn whether the program leads to increased help-seeking and well-being in students.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128282 0
Dr Kelvin (Shiu Fung) Wong
Address 128282 0
Swinburne University of TechnologyJohn Street, Hawthorn, VIC, 3122
Country 128282 0
Australia
Phone 128282 0
+61 3 9214 5161
Fax 128282 0
Email 128282 0
[email protected]
Contact person for public queries
Name 128283 0
Kelvin (Shiu Fung) Wong
Address 128283 0
Swinburne University of TechnologyJohn Street, Hawthorn, VIC, 3122
Country 128283 0
Australia
Phone 128283 0
+61 3 9214 5161
Fax 128283 0
Email 128283 0
[email protected]
Contact person for scientific queries
Name 128284 0
Kelvin (Shiu Fung) Wong
Address 128284 0
Swinburne University of TechnologyJohn Street, Hawthorn, VIC, 3122
Country 128284 0
Australia
Phone 128284 0
+61 3 9214 5161
Fax 128284 0
Email 128284 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
De-identified data will be available to other researchers on data sharing platforms (e.g., the Open Science Framework) and/or shared with colleagues for research purposes (e.g., meta-analyses). De-identified data will also be shared with the CCC Foundation Australia Inc. staff involved in the delivery and administration of The Let'sTALK Program.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Unrestricted access via web address (https://osf.io/), access subject to approvals by Principal Investigator ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19902Study protocol    386306-(Uploaded-21-09-2023-09-55-30)-Study-related document.docx



Results publications and other study-related documents

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