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Trial registered on ANZCTR


Registration number
ACTRN12618000449235
Ethics application status
Approved
Date submitted
6/03/2018
Date registered
28/03/2018
Date last updated
12/06/2019
Date data sharing statement initially provided
12/06/2019
Date results information initially provided
12/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial of online vocational support for young people with mental ill health
Scientific title
Randomised controlled trial looking at the effect of the Youth Online Training and Employment System (YOTES) on hours in paid employment for young people with mental ill health.
Secondary ID [1] 293875 0
Nil
Universal Trial Number (UTN)
Trial acronym
YOTES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental ill health 306342 0
Depression 307015 0
Anxiety 307016 0
Condition category
Condition code
Mental Health 305428 305428 0 0
Depression
Mental Health 305429 305429 0 0
Anxiety
Mental Health 306114 306114 0 0
Schizophrenia
Mental Health 306115 306115 0 0
Psychosis and personality disorders
Mental Health 306116 306116 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Youth Online Training and Employment System (#yotes), an online vocational support platform for young people with mental ill health.
#yotes comprises a platform for the delivery of a range of vocational support strategies which are enhanced by a moderated online social networking environment. Importantly, #yotes adopts a strengths-based approach through which users are guided and prompted to identify, discuss and exercise key personal strengths within the online environment and in real-life to enhance self-esteem, foster social functioning and improve mental health. This approach is based on the novel positive psychology model which poses that psychosocial interventions should aim to build strengths, meaning and purpose as well as relieve symptoms.
Specifically, #yotes integrates: i) peer-to-peer on-line social networking; ii) individually tailored interactive vocational support strategies; and (iii) expert vocational and peer moderation.
Peer-to-peer online social networking (the ‘cafe’): the ‘cafe’ includes a web feed (or newsfeed) where participants and moderators can post comments, information, upload pictures and videos, and ‘like’ different content. The newsfeed organises discussion threads into relevant themes (e.g. ‘what’s on your mind’, ‘I’m loving right now’, ‘cheers me up’ etc.). Moreover the system includes a ‘wall’ function displaying the activity of individual users, and a ‘network’ (similar to a ‘friends’ function).
Vocational support strategies (‘pathways’ and ‘steps’): #yotes includes vocational content developed using The Core Skills for Work Developmental Framework and delivered as a series of interactive ‘pathways and steps’. The pathways target key skills and behaviours across three domains of Core Skills for Work: navigating the world of work, interacting with others and getting the work done. This framework is recommended by the federal government and the Career Development Association of Australia. The pathways are divided into ‘step’ or modules. An example of a #yotes pathway is ‘Career planning’, which introduces the concept of a career as a process of continuous learning and development over the course of your life. The ‘Career planning’ pathway is comprised of three steps: ‘Interests, skills and values’, ‘career exploration’, and ‘making a career plan’. #yotes has the capacity to automatically suggest vocational content based on the participant's self-identified strengths/skills for work that the participant is encouraged to select in an activity at the beginning of their time on #yotes and that can be changed throughout.
#yotes also houses a 'job zone' where local job and training opportunities will be updated and a moderated online problem solving function where issues nominated by users are discussed through structured phases following an evidence-based problem solving framework. Example of topics that may be discussed are ‘how to balance work and study’ or ‘how to manage disclosure of mental health in the workplace’. Offered solutions and users experiences are stored in a data-base serving as a ‘wiki’ for participants.
Vocational Moderation: #yotes incorporates two types of moderation: Expert vocational moderation and peer vocational motivators. #yotes moderation has been informed by social cognitive theory and recent evidence from the computing and information systems field which posit that moderators’ can model appropriate online behaviours through demonstrating desired actions and behaviours. Expert vocational moderators will be expert vocational workers with significant experience in working with young people. Their role will be to provide guidance, monitor participant’s engagement with the system and ensure the safety of the social networking environment. Briefly, expert moderators will engage the participant in a conversation, initially by phone and then online, about their work and study goals. From there, expert moderators will suggest content from within #yotes based on the participant’s initial profile (e.g. age, level of education, working status) and their activity within the platform which is tracked by the system and accessible only by moderators in the back-end of #yotes. Other content suggested by expert moderators will be job vacancies. They will assist with the preparation of CVs, cover letters and other applications through the #yotes emailing facility. Moderators will ensure the safety of the social networking environment by reviewing all uploaded content for breaches of the #yotes terms of use as well as signs of deterioration in participant mental state. The system will be moderated daily during weekdays between the hours of 9am and 5pm. Moderators will be supervised weekly by senior vocational staff and clinicians from the research team.
Peer vocational motivation: #yotes users will also be moderated by young people with a lived experience of mental ill health who have previously overcome disruption to their educational and vocational outcomes. Peer vocational motivators will provide guidance, information and emotional peer-to-peer support within the online environment to counteract self-stigma and foster empowerment. Their role will include assistance with the induction process upon entry into #yotes and support throughout their time on #yotes. Peer vocational motivators will receive regular supervision and guidance from the expert vocational moderators and research team as needed.
#yotes is accessed through a closed website. Participant’s are advised they may use the site at their own discretion over the 6 month trial period. #yotes is programmed to capture all user activity that can be monitored in real time and will be used in analysis to measure participant engagement with the platform.
Intervention code [1] 300140 0
Behaviour
Comparator / control treatment
Treatment as usual at headspace, which includes access to a publicly available online vocational service, the headspace ‘Digital Work and Study Service’ available at: https://headspace.org.au/young-people/digital-work-and-study-program/. Participants in this group are followed up after 6 months.

The headspace Digital Work and Study service has an online chat function where young people can access advice and support from a career specialist. Options are discussed over the phone or chat function and notes can be added to the young person’s digital clinical file at headspace. Young people may also be referred to the vocational resources housed on the headspace website, for example 'The workforce: Know your rights' and 'Managing your mental health and disclosure at work'. Periodically group chats are run on a specific vocational topic such as 'Women in Leadership'.
Control group
Active

Outcomes
Primary outcome [1] 304562 0
Wether or not the #yotes intervention results in significantly increased career confidence as measured by the CFI-R score.
Timepoint [1] 304562 0
26-weeks post randomisation
Secondary outcome [1] 342410 0
Whether or not the #yotes intervention results in significantly improved congruence between preference for work hour and actual work hours. This will be assessed by a weekly work questionnaire devised by the investigator.
Timepoint [1] 342410 0
Weekly for 26 weeks post randomisation.
Secondary outcome [2] 342411 0
Whether or not the #yotes intervention results in significantly increased number of hours in paid employment. This will be assessed by a weekly work questionnaire devised by the investigator.
Timepoint [2] 342411 0
Weekly for 26 weeks post randomisation.
Secondary outcome [3] 342412 0
Whether or not the #yotes intervention results in significantly improved sense of hope. This will be assessed by The Adult State Hope Scale.
Timepoint [3] 342412 0
26 weeks post randomsiation
Secondary outcome [4] 342413 0
Whether or not the #yotes intervention results in significantly improved health economic outcomes. This will be assessed by the the Resource Use Questionnaire: (Mihalopoulos C, Chatterton M-L, Lee Y-C, Magnus, A., Shih, S. Resource use questionnaire for mental health interventions. Deakin University).
Timepoint [4] 342413 0
26 weeks post randomsiation
Secondary outcome [5] 342414 0
Whether or not the #yotes intervention results in significantly improved level of distress. This will be assessed by the Kessler Psychological Distress Questionnaire.
Timepoint [5] 342414 0
26 weeks post randomisation.
Secondary outcome [6] 342415 0
To explore the experiences and beliefs of young people who access a moderated, online intervention with social, vocational and peer support (#yotes), in terms of perceived usefulness, acceptability, and impact on their functioning, sense of hopefulness and career confidence. This will be assessed by semi-structured interview designed specifically for the study.
Timepoint [6] 342415 0
26 weeks post randomisation
Secondary outcome [7] 371443 0
Whether or not the #yotes intervention results in significantly increased number of hours in paid employment. This will be assessed by a weekly work questionnaire devised by the investigator.
Timepoint [7] 371443 0
52-weeks post randomisation
Secondary outcome [8] 371444 0
Wether or not the #yotes intervention results in significantly increased career confidence as measured by the CFI-R score.
Timepoint [8] 371444 0
52-weeks post randomisation
Secondary outcome [9] 371445 0
Whether or not the #yotes intervention results in significantly improved congruence between preference for work hour and actual work hours. This will be assessed by a weekly work questionnaire devised by the investigator.
Timepoint [9] 371445 0
52-weeks post randomisation
Secondary outcome [10] 371446 0
Whether or not the #yotes intervention results in significantly improved sense of hope. This will be assessed by The Adult State Hope Scale.
Timepoint [10] 371446 0
52-weeks post randomisation.
Secondary outcome [11] 371447 0
Whether or not the #yotes intervention results in significantly improved health economic outcomes. This will be assessed by the the Resource Use Questionnaire: (Mihalopoulos C, Chatterton M-L, Lee Y-C, Magnus, A., Shih, S. Resource use questionnaire for mental health interventions. Deakin University).
Timepoint [11] 371447 0
52-weeks post randomisation.
Secondary outcome [12] 371448 0
Whether or not the #yotes intervention results in significantly improved level of distress. This will be assessed by the Kessler Psychological Distress Questionnaire.
Timepoint [12] 371448 0
52-weeks post randomisation.
Secondary outcome [13] 371449 0
To explore the experiences and beliefs of young people who access a moderated, online intervention with social, vocational and peer support (#yotes), in terms of perceived usefulness, acceptability, and impact on their functioning, sense of hopefulness and career confidence. This will be assessed by semi-structured interview designed specifically for the study.
Timepoint [13] 371449 0
52-weeks post randomisation.

Eligibility
Key inclusion criteria
1) Aged between 16-25 years old inclusive
2) Current client at a headspace centre.
headspace is designed to make it as easy as possible for a young person and their family to access the help they need for problems affecting their mental, social and emotional wellbeing. Almost three-quarters of young people who sought help at centres during the 2013/14 financial year had high and very high levels psychological distress at first assessment (74.2%). However, clients do not need to have a mental health diagnoses to receive treatment at headspace.
3) Seeking vocational assistance
4) Access to the Internet (e.g. via computer, tablet or smartphone)
Minimum age
16 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide informed consent
Inability to use the platform (e.g. insufficient language skills)

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Quantitative data:
Frequencies and percentages will be calculated for responses to binary variables and means and standard deviations for continuous variables. Nonparametric statistics will be used to compare categorical variables. Between-group t-tests will be used to compare the continuous demographic variables and the primary outcome. If significant differences are found, effect sizes (e.g. Cohen’s d) will be calculated to assess the magnitude of the difference between groups. Statistical analyses will be conducted with IBM SPSS Statistics, version 22.0.
Qualitative data:
Semi-structured interviews will be audio recorded, transcribed and analysed using thematic analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9870 0
Headspace Glenroy - Glenroy
Recruitment hospital [2] 9871 0
Headspace Sunshine - Sunshine
Recruitment hospital [3] 10258 0
Headspace Bentleigh - Bentleigh
Recruitment hospital [4] 10259 0
Headspace Elsternwick - Elsternwick
Recruitment postcode(s) [1] 18659 0
3046 - Glenroy
Recruitment postcode(s) [2] 18660 0
3020 - Sunshine
Recruitment postcode(s) [3] 18665 0
3204 - Bentleigh
Recruitment postcode(s) [4] 21925 0
3185 - Elsternwick

Funding & Sponsors
Funding source category [1] 298498 0
Charities/Societies/Foundations
Name [1] 298498 0
Helen McPherson Smith Trust
Address [1] 298498 0
27 Windsor Place
Melbourne Victoria 3000
Country [1] 298498 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orygen, The National Centre in Youth Mental Health
Address
35 Poplar Rd Parkville, VIC, 3052
Country
Australia
Secondary sponsor category [1] 297638 0
None
Name [1] 297638 0
Address [1] 297638 0
Country [1] 297638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299480 0
The University of Melbourne Human Research Ethics
Ethics committee address [1] 299480 0
Research Ethics & Integrity
Level 4, 161 Barry Street
The University of Melbourne
Parkville
VIC 3010
Ethics committee country [1] 299480 0
Australia
Date submitted for ethics approval [1] 299480 0
15/08/2017
Approval date [1] 299480 0
24/10/2017
Ethics approval number [1] 299480 0
1750051.3
Ethics committee name [2] 299830 0
Alfred Health Ethics Committee
Ethics committee address [2] 299830 0
The Alfred
PO Box 315
Prahran VIC 3181
Ethics committee country [2] 299830 0
Australia
Date submitted for ethics approval [2] 299830 0
12/12/2017
Approval date [2] 299830 0
20/02/2018
Ethics approval number [2] 299830 0
6/18

Summary
Brief summary
This research project is investigating online support for young people looking for work. Young people who experience mental ill health often also experience disruption to school and work. This project will look at whether or not online platforms can help young people find and stay in work.
Young people who agree to take part in the project will be randomly assigned to use one of two online platforms. These platforms are both designed to help young people find work and stay in work. They include ways to learn about looking for work, work skills, and information about workforce participation. Depending on which platform participants are allocated to, you may also receive online help from vocational support people and/or talk to other young people online about looking for work. Each component of the platforms are optional and there is no minimum time that you have to spend on the platform.

You will also be asked to complete questionnaires about yourself (e.g. demographic information, questions about your mental health, questions about hopefulness and how confident you feel about work) and about looking for work and your work history. You will be asked to complete these questionnaires at three times: 1) when you start as a participant in the study (baseline), 2) 26-weeks after baseline, and 3) 25-weeks after baseline. You will also be asked to let us know how many hours you have worked each week for 26 weeks. Each time you complete the questionnaires it will take approximately 45 minutes. You can complete these questions online and will be reimbursed $20 for the questionnaires that are done at the start (baseline), middle (26-weeks), and end of the study (52-weeks).

You may also be asked to participate in an interview about your experiences of using the online platform. We will ask you what you thought of different sections of the platform and what it was like in terms of helping you look for and obtain work. This interview would be at the middle of the study (26-weeks) and again close to the end of the study (52-weeks). If you agree to do this, the interview will be audio recorded and transcribed. This is because it is the best way to remember exactly what you said in the interview. When the recording is transcribed any details that identify you (e.g. name) will be removed. The interviews will last approximately 45-60 minutes depending on how much you have to say and you will be reimbursed $30 for your time and travel expenses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80550 0
Dr Magenta Simmons
Address 80550 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd,
Parkville, VIC, 3052
Country 80550 0
Australia
Phone 80550 0
+61 413 733 177
Fax 80550 0
Email 80550 0
magenta.simmons@orygen.org.au
Contact person for public queries
Name 80551 0
Dr Magenta Simmons
Address 80551 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd,
Parkville, VIC, 3052
Country 80551 0
Australia
Phone 80551 0
+61 413 733 177
Fax 80551 0
Email 80551 0
magenta.simmons@orygen.org.au
Contact person for scientific queries
Name 80552 0
Dr Magenta Simmons
Address 80552 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd,
Parkville, VIC, 3052
Country 80552 0
Australia
Phone 80552 0
+61 413 733 177
Fax 80552 0
Email 80552 0
magenta.simmons@orygen.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have approval for this to occur.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary