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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07114887
Registration number
NCT07114887
Ethics application status
Date submitted
8/07/2025
Date registered
11/08/2025
Date last updated
11/08/2025
Titles & IDs
Public title
Virtual Reality for Vocational Recovery
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Scientific title
Enhancing Vocational Support With a Virtual Reality Vocational Skills Building Application: Piloting VR4VR
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Secondary ID [1]
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ORY-P05-24-31
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Universal Trial Number (UTN)
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Trial acronym
VR4VR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mental Health Disorder
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - Virtual reality for vocational recovery
Experimental: Virtual reality for vocational recovery - Within standard vocational care, young people will receive a three-session (optional 4th) virtual reality training intervention to address key challenges associated with educational and employment attainment and maintenance.
Session 1: Approaching potential employers Session 2: Asking for reasonable adjustments Session 3: Managing customers
BEHAVIORAL: Virtual reality for vocational recovery
Intervention is an immersive virtual reality (VR) intervention, delivered through a VR headset, supported by a trained vocational specialist. Intervention content was co-designed with young people with mental health and vocational challenges, and vocational specialists with experiencing supporting this population. Content was guided by goals of vocational programs, including Individual Placement and Support.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility - recruitment rates
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Assessment method [1]
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Rates of recruitment for the study (young people and vocational and service staff) based on an audit of study enrolment
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Timepoint [1]
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6 months post intervention commencement
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Primary outcome [2]
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Acceptability
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Assessment method [2]
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Acceptability as measured by the Theoretical Framework of Acceptability Measure delivered to young people and vocational specialists. Total mean score across the 7 TFA items will be reported, on a scale of 1 to 5, with 5 indicating greater acceptability.
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Timepoint [2]
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6 weeks post intervention commencement
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Primary outcome [3]
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Safety - adverse events
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Assessment method [3]
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The number of serious adverse events specifically related to the intervention or trial
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Timepoint [3]
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6 weeks post intervention commencement
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Primary outcome [4]
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Feasibility - consent rates
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Assessment method [4]
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Rates of consent for the study (young people and vocational and service staff) based on an audit of consent logs
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Timepoint [4]
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6 months post intervention commencement
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Secondary outcome [1]
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Feasibility - attendance rates of assessments and sessions
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Assessment method [1]
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Via audit of attendance logs
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Timepoint [1]
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6 weeks post intervention commencement
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Secondary outcome [2]
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Feasibility - delivery of VR4VR
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Assessment method [2]
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Proportion of trained vocational specialists who use the intervention during the trial period
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Timepoint [2]
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6 months post intervention commencement
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Secondary outcome [3]
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Feasibility - VR utilisation
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Assessment method [3]
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Proportion of sessions within the intervention period in which VR was used within intervention sessions.
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Timepoint [3]
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6 months post intervention commencement
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Secondary outcome [4]
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Acceptability - cybersickness
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Assessment method [4]
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Cybersickness as measured by the Simulator Sickness Questionnaire. 16 items across three domains, nausea, Oculomotor and disorientation are summed to produce a total score. Items are scored on a scale from 0 to 3, with a higher score indicating greater cybersickness symptoms.
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Timepoint [4]
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6 weeks post intervention commencement
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Secondary outcome [5]
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Acceptability - VR presence
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Assessment method [5]
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Sense of 'being there' within the VR environment measured using the Igroup Presence Questionnaire. Total score is calculated by summing all items. Items are rated on a scale of -3 to 3, with a higher scoring indicating greater sense of presence.
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Timepoint [5]
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6 weeks post intervention commencement
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Secondary outcome [6]
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Effectiveness - Social and occupational functioning
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Assessment method [6]
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Young person functioning measured by the single item social and occupational functioning scale, ranging from 0 to 100, with lower scores indicating poorer functioning.
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Timepoint [6]
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6 weeks post intervention commencement
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Secondary outcome [7]
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Effectiveness - Occupational self-efficacy
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Assessment method [7]
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Young person self-efficacy around employment measured by occupational self-efficacy scale. Items rated on a scale tanging from 1 to 6, with higher vales reflecting higher occupational self-efficacy.
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Timepoint [7]
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6 weeks post intervention commencement
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Secondary outcome [8]
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Effectiveness - General self-efficacy
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Assessment method [8]
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Young person self-efficacy using the general self-efficacy scale, to assess an individual's perceived generalised capabilities to respond to a variety of challenges and situations. Scores range from 1-4 with highest scores indicating higher self-efficacy. The total score is calculated by finding the sum of the all items.
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Timepoint [8]
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6 weeks post intervention commencement
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Secondary outcome [9]
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Feasibility - intervention implementation
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Assessment method [9]
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Feasibility of Implementation Measure (completed by service leads and clinicians)
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Timepoint [9]
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up to 6 months post intervention commencement
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Secondary outcome [10]
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Vocational specialist confidence and competence
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Assessment method [10]
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Purpose-built scale (no title or acronym) developed specifically for the current study capturing self-report vocational specialist confidence and competence using VR for vocational support. The scale is 8 items, scored of a scale of 1 to 4. Higher score indicates a greater degree of competence with VR4VR.
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Timepoint [10]
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Immediately post-training
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Secondary outcome [11]
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Implementation - perceived barriers and enablers to use in practice
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Assessment method [11]
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Assessed through qualitative analysis of supervision meeting minutes with vocational specialists
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Timepoint [11]
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Through study completion an average of 6 months
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Secondary outcome [12]
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Implementation - perceived barriers and enablers to use in practice
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Assessment method [12]
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Assessed through qualitative analysis of research meeting minutes
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Timepoint [12]
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Through study completion an average of 6 months
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Secondary outcome [13]
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Implementation - perceived barriers and enablers to use in practice
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Assessment method [13]
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Assessed through qualitative analysis of post-intervention interviews focusing on participants' experiences of using the VR4VR intervention during vocational support.
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Timepoint [13]
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Through study completion an average of 6 months
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Secondary outcome [14]
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Feasibility - fidelity
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Assessment method [14]
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Proportion of VR4VR sessions that are delivered per-protocol, assessed by the timing of sessions.
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Timepoint [14]
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6 months post intervention commencement
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Eligibility
Key inclusion criteria
A young person participant will be considered eligible for inclusion in this study if:
1. They are aged 18-25 seeking vocational support at participating vocational support programs
2. Have a named care-coordinator or key worker
3. Comfortable using a VR headset
4. Consent to recording of interview for transcription
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Minimum age
18
Years
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. They lack fluency in English (spoken and written), since this is required to understand participate in the VR intervention;
2. They have a known diagnosis of a moderate intellectual disability, due to some of the content delivered during the intervention requiring a certain level of understanding.
3. As the therapy uses audio and visual means of communication, participants with impairments so severe that they cannot hear instructions, or are unable to see the virtual reality environments, cannot participate. Mild impairments can be accommodated, as sound volume can be turned up, and the Meta Quest headband is used to comfortably use glasses with the headset.
A vocational specialist or staff participant will be considered eligible for inclusion in this study if:
1. Presently work within a vocational program and hold a caseload of young people
2. Have worked with at least 5 young people within a vocational intervention.
3. Sufficient command of the English language
4. Consent to audio recording of interview
No exclusion criteria
A staff participant will be considered eligible for inclusion in this study if:
1. Presently work within a role supporting a vocational program
2. Sufficient command of the English language
3. Consent to audio recording of interview
No exclusion criteria
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Study design
Purpose of the study
Other
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Allocation to intervention
Not applicable
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/08/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Veritas House - Orange
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Recruitment hospital [2]
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Orygen Specialist Services - Melbourne
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Recruitment hospital [3]
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Youth Focus Burswood - Perth
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Recruitment postcode(s) [1]
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2800 - Orange
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Recruitment postcode(s) [2]
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3052 - Melbourne
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Recruitment postcode(s) [3]
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6056 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Orygen
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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TAL Community Foundation
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Melbourne
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Unemployment is higher among young people who experience mental ill-health compared to the general population. This can have a lasting impact on young people, many of whom are highly motivated to gain employment and education. There are many challenges to seeking, gaining, and maintaining employment for young people. To address these challenges and help young people meet their employment and education goals, investigators have developed a VR intervention to support vocational skill building. The aim of the current study is to evaluate the feasibility, acceptability, and safety, of the Virtual Reality for Vocational Recovery (VR4VR) intervention. A small group of vocational specialists will support up to 20 young people with their vocational outcomes using VR4VR over a 3-6week period. Both young people and specialists will complete questionnaires related to acceptability of the intervention, including qualitative interviews. Data on feasibility and safety will also be collected. Results will inform whether VR is feasible, acceptable, and safe to support vocational outcomes within vocational services that support young people with mental health difficulties, potentially supporting further intervention development and larger trials.
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Trial website
https://clinicaltrials.gov/study/NCT07114887
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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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Jennifer Nicholas, PhD
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jennifer M Nicholas, PhD
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Address
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Country
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Phone
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+61399669235
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Unable to share individual participant data due to restrictions from ethics approval and small exploratory nature of the current trial.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07114887
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