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Trial registered on ANZCTR
Registration number
ACTRN12625000295448
Ethics application status
Approved
Date submitted
5/04/2025
Date registered
14/04/2025
Date last updated
14/04/2025
Date data sharing statement initially provided
14/04/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Changes in Self-esteem in University Students via a Digital Coach
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Scientific title
Changes in Self-esteem in University Students via a Digital Coach
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Secondary ID [1]
314102
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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:
Low self-steem
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Condition category
Condition code
Mental Health
333358
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Following completion of the baseline (T1) measures, participants will engage with a conversational agent (CA) called HAFSE (Helper Agent for Self Esteem). HAFSE is logic based conversational agent. Engagement will involve the agent introducing themselves and then asking participants questions which encourage self-reflection and intention. HAFSE will interact with participants by speaking (digital voice) and text (her conversation will also appear as text). During the conversation, participants will be able to select answers from a pre-defined set of options which will allow them to direct the conversation. The expected interaction time is about 20 minutes.
There will be only one brief online interaction.
There are three conversations discussing:
1. How to change 3 common negative thinking styles (1, all-or-nothing thinking, 2 Magnifying or exaggerating negative experiences, 3. Minimising positives);
2. The value of keeping a Positive Self Diary.
3. Positive self-affirmations.
Participants will access the conversational agent via a website link accessible within the online survey.
We will capture responses during the conversation and will ask if they found the strategies helpful at the end of the session (T2), at 1-week follow-up (T3) and at 1-month follow-up (T4). In the study, all participants will do conversation 1, but they will get to choose between doing conversation 2 and 3. We will ask them if they would like to access later the conversation they did not choose.
Engagement and interaction with HAFSE will be assessed via asking participants questions at the end of the interaction as to how helpful and useful they found their interaction with HAFSE. A unique code identifier (anonymized) will also be generated with accessing the HAFSE program, which will enable the researchers to also monitor how long in minutes and seconds each participant spent interacting with the HAFSE program.
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Intervention code [1]
330676
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Lifestyle
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Intervention code [2]
330788
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Behaviour
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Comparator / control treatment
This is an uncontrolled study.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Change in Self-esteem
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Assessment method [1]
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State Self Esteem Scale (SSES) (Heatherton & Polivy, 1991) consisting of 20 questions.
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Timepoint [1]
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Baseline and after 20 minute psycho-education with HAFSE (2, primary timepoint), 1-week (T3) and 1-month (T4) follow-up.
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Primary outcome [2]
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Change in Self Esteem
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Assessment method [2]
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Rosenberg Self Esteem Scale (RSES) (Rosenberg, 1965) consisting of a 10 item questionnaire
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Timepoint [2]
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Baseline and after 20 minute psycho-education with HAFSE (2, primary timepoint), 1-week (T3,) and 1-month (T4) follow-up.
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Secondary outcome [1]
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Changes in self-efficacy for learning and performance
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Assessment method [1]
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Participants will be administered the Self-Efficacy for Learning and Performance (SE/LP) scale (Pintrich et al., 1991) - an 8 item scale to index changes in participants' perceived efficacy in learning and performance in undertaking their university course studies.
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Timepoint [1]
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Baseline (T1) - and then again at 1-week (T3) and 1-month (T4) follow-ups.
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Secondary outcome [2]
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Changes in self-compassion
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Assessment method [2]
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Participants will be administered the Self-compassion Scale - Short form (SCS-SF) (Raes et al., 2022) - which is a 12-item measure to assess changes in self-compassion.
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Timepoint [2]
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Baseline (T1) - and then again post-program completion (T2), 1-week (T3) and 1-month (T4) follow-ups.
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Secondary outcome [3]
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Shifts in cognitive appraisal strategies
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Assessment method [3]
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1) The Perceived Positive Attributional Style Scale (PPAS) (Petri-Romao et al., 2024) - a 14 item scale will be administered to measure shifts in how participants appraise their situational life stressors. 2) The Cognitive Emotion Regulation Questionnaire (CERQ) (Garnefski & Kraaij, 2001) - 4 subscales from the CERQ will be administered to index changes in i) self-blame, ii) acceptance, iii) rumination, and iv) positive reappraisal.
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Timepoint [3]
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Baseline (T1) - and then again at 1-week (T3) and 1-month (T4) follow-ups.
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Secondary outcome [4]
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Change in Self-Efficacy
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Assessment method [4]
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Participants will be administered the General Self-efficacy Scale (GSES) (Schwarzer & Jerusalem, 1995) which is a 10-item measure to index shifts in perceived self-efficacy.
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Timepoint [4]
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Baseline (T1) - then again at 1-week (T3) and 1-month (T4) follow-ups.
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Secondary outcome [5]
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Change in affective states
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Assessment method [5]
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Participants will be administered the Positive and Negative Affect Scale (PANAS) (Watson et al., 1998) - a 20 item measure to index changes in both positive and negative affect states.
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Timepoint [5]
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Baseline (T1) - and then again post-program completion (T2), 1-week (T3) and 1-month (T4) follow-ups.
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Secondary outcome [6]
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Changes in achievement related emotions.
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Assessment method [6]
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Participants will be administered the Achievement Emotions Questionnaire (AEQ) (Pekrun et al., 2011) - an 8 item scale to measure participants emotions related to their university learning and performance.
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Timepoint [6]
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Baseline (T1) - and then again at 1-week (T3) and 1-month (T4) follow-ups.
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Secondary outcome [7]
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Extent of a human-agent (avatar) working alliance
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Assessment method [7]
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The Session Rating Scale (SRS) (Duncan et al., 2003) will be administered to measure satisfaction with the 20-minute educational session with HAFSE the conversational agent.
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Timepoint [7]
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Immediately following the 20-minute psycho-educational interaction with HAFSE
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Eligibility
Key inclusion criteria
To be eligible to take part in this study participants must meet the following criteria:
1) Currently enrolled in a course at university (Sydney based institution).
2) Not currently receiving any professional psychotherapy (from a psychologist, counsellor, psychiatrist etc.).
3) Not currently experiencing severe levels of anxiety, depression, stress or other mental health problems. The DASS-8 (Depression Anxiety and Stress Scale) will be used to screen participants into the study.
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Minimum age
18
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
Participants scoring in the severe range on the DASS-8 (Depression Anxiety and Stress Scale) will be excluded from the study. The DASS-8 will be used as an initial screening measure.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/04/2025
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Actual
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Date of last participant enrolment
Anticipated
19/12/2025
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Actual
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Date of last data collection
Anticipated
20/01/2026
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Actual
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Sample size
Target
170
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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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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Macquarie University
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Macquarie University
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Address
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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]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Macquarie University Human Research Ethics Committee Medical Sciences
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Ethics committee address [1]
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https://www.mq.edu.au/research/ethics-integrity-and-policies/ethics/human-ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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25/02/2025
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Approval date [1]
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04/03/2025
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Ethics approval number [1]
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520251884361642
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Summary
Brief summary
In 2024, we conducted the first pilot feasibility trial to test the effectiveness of an Embodied Conversational Agent (ECA) HAFSE (Helper Agent For Self Esteem) to increase the self-esteem in university (psychology) students. For this initial study, (Tahir, Richards & Kangas., 2024), We found that the HAFSE program, a brief (20 minute) psychoeducational program for increasing self-esteem was effective in increasing self-esteem (with moderate effects) following the completion of this course. Given our 2024 pilot study was based on a pre-post-trial design we did not collect follow-up data to evaluate retention effects of self-esteem and self-efficacy improvements as well as investigate any secondary gains to improve students' confidence in learning and engagement at university. The overarching aim of the current study is to further investigate the effectiveness of the HAFSE program to enhance the self-esteem and improve well-being in university students enrolled at Macquarie University across various courses. We aim to test the short-term effects of this program (at 1-month follow-up) as well as test moderator and mediator effects to determine factors contributing to the benefits of this program.
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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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Prof Maria Kangas
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Address
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Australian Hearing Hub (AHH) L2.684, Macquarie University, NSW 2109
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Country
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Australia
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Phone
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+61 298508599
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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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Maria Kangas
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Address
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Australian Hearing Hub (AHH) L2.684, Macquarie University, NSW 2109
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Country
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Australia
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Phone
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+61 298508599
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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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Maria Kangas
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Address
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Australian Hearing Hub (AHH) L2.684, Macquarie University, NSW 2109
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Country
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Australia
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Phone
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+61 298508599
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing 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.
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