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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
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Scientific title
Evaluating the Effect of a Psychological Safety Program on Help-Seeking and Well-Being in Primary School Students: A Randomised Controlled Trial
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Secondary ID [1]
310214
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psychological safety
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Help-seeking behaviours
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General psychological distress
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Condition category
Condition code
Mental Health
327683
327683
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0
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Studies of normal psychology, cognitive function and behaviour
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Public Health
328518
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
326603
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Behaviour
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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).
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Control group
Active
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Outcomes
Primary outcome [1]
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Student strengths and difficulties will be assessed using the Strengths and Difficulties Questionnaire - Youth Self-Report (SDQ-YSR).
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Assessment method [1]
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Timepoint [1]
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Baseline, 3, 6, 9, and 11 months (primary timepoint) after beginning the intervention.
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Primary outcome [2]
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Student well-being will be assessed using the Stirling Children's Well-Being Scale (SCWBS).
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Assessment method [2]
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Timepoint [2]
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Baseline, 3, 6, 9, and 11 months (primary timepoint) after beginning the intervention.
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Primary outcome [3]
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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?
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Assessment method [3]
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Timepoint [3]
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Baseline, 3, 6, 9, and 11 months (primary timepoint) after beginning the intervention.
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Secondary outcome [1]
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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).
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Assessment method [1]
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Timepoint [1]
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Baseline, 3, 6, 9, and 11 months (primary timepoint) after beginning the intervention.
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Secondary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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3, 6, 9, and 11 months (primary timepoint) after beginning the intervention.
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Secondary outcome [3]
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Teacher psychological safety will be assessed using the People at Work Survey.
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Assessment method [3]
424789
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Timepoint [3]
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Baseline, 6, and 11 months (primary timepoint) after beginning the intervention.
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Secondary outcome [4]
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Student strengths and difficulties will be assessed using the Strengths and Difficulties Questionnaire - Teacher Report (SDQ-TR). This is also a PRIMARY outcome.
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Assessment method [4]
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Timepoint [4]
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Baseline, 3, 6, 9, and 11 months (primary timepoint) after beginning the intervention.
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Eligibility
Key inclusion criteria
Teachers and students of participating Victorian primary schools. Computer and internet-literate.
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Minimum age
8
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Schools will be randomly assigned to conditions using central randomisation by computer.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
20/11/2023
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Actual
2/02/2024
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Date of last participant enrolment
Anticipated
28/06/2024
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Actual
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Date of last data collection
Anticipated
20/12/2024
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Actual
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Sample size
Target
190
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Accrual to date
372
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Swinburne University of Technology
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Address [1]
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Swinburne University of TechnologyJohn Street, Hawthorn, VIC, 3122
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Country [1]
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Australia
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Funding source category [2]
314508
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Charities/Societies/Foundations
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Name [2]
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CCC Foundation Australia Inc.
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Address [2]
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4 Rylandes DriveGladstone Park, VIC, 3043
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Country [2]
314508
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
CCC Foundation Australia Inc.
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Address
4 Rylandes DriveGladstone Park, VIC, 3043
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
316453
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Swinburne University Human Research Ethics Committee
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Ethics committee address [1]
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Swinburne University of TechnologyPO Box 218, Hawthorn, VIC, 3122
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
313471
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04/08/2023
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Approval date [1]
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18/09/2023
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Ethics approval number [1]
313471
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20237392-16644
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Kelvin (Shiu Fung) Wong
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Address
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Swinburne University of TechnologyJohn Street, Hawthorn, VIC, 3122
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Country
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Australia
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Phone
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+61 3 9214 5161
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Kelvin (Shiu Fung) Wong
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Address
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Swinburne University of TechnologyJohn Street, Hawthorn, VIC, 3122
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Country
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Australia
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Phone
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+61 3 9214 5161
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Kelvin (Shiu Fung) Wong
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Address
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Swinburne University of TechnologyJohn Street, Hawthorn, VIC, 3122
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Country
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Australia
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Phone
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+61 3 9214 5161
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
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When will data be available (start and end dates)?
Immediately following publication, no end date.
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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.
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Available for what types of analyses?
Any purpose.
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How or where can data be obtained?
Unrestricted access via web address (https://osf.io/), access subject to approvals by Principal Investigator (
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
19902
Study protocol
386306-(Uploaded-21-09-2023-09-55-30)-Study-related document.docx
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.
Download to PDF