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Trial registered on ANZCTR


Registration number
ACTRN12619001220156
Ethics application status
Approved
Date submitted
8/08/2019
Date registered
3/09/2019
Date last updated
3/09/2019
Date data sharing statement initially provided
3/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
INVEST: Individualised vocational support for youth with borderline personality disorder: A randomised controlled trial
Scientific title
Individualised vocational support for youth with borderline personality disorder: A randomised controlled trial investigating vocational outcomes with Individual Placement and Support compared with usual vocational services
Secondary ID [1] 296152 0
NHMRC: 1144022
Universal Trial Number (UTN)
Trial acronym
INVEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline personality disorder 309752 0
Condition category
Condition code
Mental Health 308552 308552 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individual Placement and Support (IPS)

IPS is an evidence based vocational services model for people with mental illness, with eight core principles:
1. Competitive employment/mainstream education. This principle describes the main aim of IPS. Job seekers are helped to find employment in the open labour market and students are assisted to engage with mainstream education. Vocational specialists do not help in finding sheltered employment, unpaid internships or jobs set aside for people with mental illness so often associated with the stepwise approach which has dominated the vocational rehabilitation sphere.
2. Eligibility based on client choice. No one is excluded on the basis of vocational readiness, diagnoses, severity of disability, symptoms, substance abuse or legal system involvement. The basis of involvement in an IPS service is based on desire to work in a competitive job or to be in mainstream education.
3. Integration of vocational services and mental health services. This means IPS providers and mental health treatment teams are not only collocated but are closely integrated and work collaboratively. Vocational specialists attend treatment team meetings and share ideas and information to develop ways to improve client functioning and recoveries.
4. Attention to Client Preferences. Vocational searches are based on individual client preferences rather than vocational provider judgements. Vocational searches are based on what the client wants, their strengths and previous experiences. Vocational seekers list their education and employment history, and identify characteristics they liked about previous vocational roles. Employment clients also decide on work settings, wages and hours. Vocational specialists provide suggestions to expand options and discuss the advantages and disadvantages of disclosing their illness to the prospective employers/educational institutions. Job seekers also determine whether vocational specialists will be in direct contact with employers and discuss the types of supports they require.
5. Personalised benefits counselling. Vocational specialists provide or help find accurate and understandable information about the effects work/education will have on the job seeker’s welfare payments.
6. Rapid vocational search. IPS providers start looking for vocational opportunities immediately and help seekers to find work/education as soon as possible, rather than providing lengthy assessments and counselling. Vocational specialists work with clients in the first session to develop a plan and vocational profile based on client preferences, past experiences, skills, strengths, career goals and education.
7. Systematic job/educational development. IPS providers must build employer and education networks and relationships through systematic contacts. This refers to creating relationships with employers/educators by understanding the business and human resources.
8. Time unlimited and individualised support. This means that vocational seekers can continue to receive support for as long as they require, up to 9 months in the case of the present study. IPS providers continue ongoing supports long after employment/education is found. Frequent contacts between vocational specialists and clients are important even once in work/education to help with any required training and difficulties faced in the new environment.

Participants assigned to IPS will have an initial face-to-face consultation with their vocational specialist within 14 days following randomisation. Subsequent contact may be face-to-face, by telephone, text message, email, and the frequency is dependent upon the needs of each client. Each interaction between vocational specialist and young person will be recorded on a checklist, detailing method, content, and duration. The vocational specialist will work with each young person to establish their skills, preferences, and needs. This will inform building a vocational plan, based on long-term career goals. Training may include apprenticeships, or other courses, that will allow the client to obtain skills or qualifications necessary or beneficial to attaining their vocational goals.

The IPS fidelity scale, including educational and employment information, as well as vocational specialist checklists and notes, will be used to review the level of adherence to eight core principles of the model. For example, the fidelity review includes monitoring of case load, integration of vocational specialist within clinical team, client placement outcomes etc.
Intervention code [1] 312478 0
Other interventions
Comparator / control treatment
Usual Vocational Services (UVS)

Orygen Youth Health currently offers a range of educational support for young people who are aged 15-18 years, the details of which are below. Employment support, and educational support for those aged 19-25, is not provided as part of UVS at Orygen Youth Health. Case managers inform young people about this type support, which can be obtained through Centrelink and/or employment agencies and case managers refer to such agencies.

Travancore Education is a program of the Travancore School in conjunction with Orygen Youth Health (OYH). The program is available to young people between 15 and 18 years old, with the educational objective of maintaining engagement with education or re-engaging young people into an appropriate educational settings.
Control group
Active

Outcomes
Primary outcome [1] 307518 0
IPS efficacy (vocational outcomes) as measured by number of days in mainstream/competitive education/employment. Number of days will be recorded via weekly text messages to participants (eg "Thinking about the past 7 days, not including today, on how many days did you attend work or employment for which you were paid?"). In addition, participants will be asked to estimate at each research assessment how many days have been spent in education and/or employment.
Timepoint [1] 307518 0
Primary endpoint at 52 weeks from baseline assessment. Outcome measures will be assessed at research visits 13, 26, 39 and 52 weeks. Outcome will also be assessed weekly via text messages to each participant.
Secondary outcome [1] 352175 0
Cost effectiveness of IPS (composite secondary outcome) compared with UVS, measured using information from multiple sources, including Resource Use Questionnaire (RUQ), Work Productivity and Action Impairment Questionnaire + Classroom Impairment Questions (WPAI+CIQ), Medicare Benefits Scheme and Pharmaceutical Benefits Scheme data (MBS/PBS), welfare benefits as primary source of income, commencements of welfare benefits since baseline, intervention costs, quality adjusted life years (QALYs measured using AQoL-8D).
Timepoint [1] 352175 0
Outcome measures will be assessed at research visits 0, 13, 26, 39 and 52 weeks.
Secondary outcome [2] 352176 0
Change in quality of life, as measured by Assessment of Quality of Life ( AQoL-8D)
Timepoint [2] 352176 0
Outcome measures will be assessed at research visits 0, 13, 26, 39 and 52 weeks.
Secondary outcome [3] 352177 0
Change in BPD symptom severity (composite secondary outcome), as measured by the Borderline Personality Disorder Severity Index (BPDSI-IV) and Borderline Symptom List ( BSL-23)
Timepoint [3] 352177 0
Outcome measures will be assessed at research visits 0, 13, 26, 39 and 52 weeks.

Eligibility
Key inclusion criteria
1. All genders
2. Aged 15-25, inclusive
3. 3 or more BPD criteria, as measured by SCID-5 PD
4. Desire to enter competitive employment and/or mainstream education
5. Sufficient fluency in English
6. Ability to provide informed consent and to adhere to study protocol
Minimum age
15 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to comply with informed consent procedure or study protocol
2. Participation in another trial which, in the opinion of the Investigator and/or clinical team, might confound the trial results or be too burdensome for the individual

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment allocation concealment will be achieved using a password-protected computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be assigned randomly and consecutively, in a 1:1 ratio, to one of two interventions. Randomisation sequence will be computer-generated and implemented by a qualified person and will be password-protected. Treatment allocation will use randomised permuted blocking and participants will be stratified by age (<18 years old; mean age of HYPE patients) and gender.
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
The main intent-to-treat data analysis will employ a t-test to compare the two treatment groups in terms of the primary outcome measure. As a secondary analysis, age and gender (the two stratifying variables in randomisation) will be used as covariates and the two treatment groups will be compared using the general linear model. Other covariates such as educational level and employment history will also be considered. Logistic regression and general linear model analysis will be employed to analyse the secondary outcome measures, depending on the nature of the measures. Multiple imputation will be considered if the amount of missing values is non-trivial.

Recruitment
Recruitment status
Not yet 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

Funding & Sponsors
Funding source category [1] 300739 0
Government body
Name [1] 300739 0
National Health and Medical Research Council
Address [1] 300739 0
16 Marcus Clarke St, (GPO Box 1421). Canberra City ACT 2600
Country [1] 300739 0
Australia
Funding source category [2] 301068 0
Charities/Societies/Foundations
Name [2] 301068 0
Perpetual - Impact Philanthropy Grant
Address [2] 301068 0
GPO Box 4171, Sydney NSW 2001
Country [2] 301068 0
Australia
Primary sponsor type
Other
Name
Orygen, The National Centre of Excellence in Youth Mental Health
Address
Locked bag 10, Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 300276 0
None
Name [1] 300276 0
Address [1] 300276 0
Country [1] 300276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301521 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 301521 0
Office for Research, Level 2, South West, 300 Grattan Street, Parkville, Victoria 3050
Ethics committee country [1] 301521 0
Australia
Date submitted for ethics approval [1] 301521 0
12/06/2018
Approval date [1] 301521 0
17/09/2018
Ethics approval number [1] 301521 0
HREC/18/MH/257 and 2018.146

Summary
Brief summary
Young people with borderline personality disorder (BPD) have difficulty engaging in and maintaining employment or education, despite having the desire to do so. Despite this, no randomised controlled trial (RCT) has investigated the effectiveness of targeted vocational services in this group. This is a single-centre, 52-week, parallel arm, ‘single blind’ RCT of Individual Placement and Support (IPS), compared with Usual Vocational Services (UVS). The primary endpoint is 52 weeks. The background treatment will be standardised across both groups in the Helping Young People Early (HYPE) early intervention program for BPD at Orygen Youth Health. Potential participants will be identified by liaising with HYPE clinicians with regard to clients’ vocational wishes and by using HYPE’s standardised assessment for DSM-5 BPD. Following screening and baseline assessment, participants will be assigned randomly and consecutively in a 1:1 ratio to one of two interventions – IPS or UVS. Research assessments will occur at 13, 26, 39 and 52 weeks. The primary outcome is number of days in mainstream education/competitive employment since baseline. Secondary outcomes are cost effectiveness of intervention, quality of life, and BPD severity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87274 0
Prof Andrew Chanen
Address 87274 0
Orygen, The National Centre of Excellence in Youth Mental Health, Locked bag 10, Parkville, VIC 3052
Country 87274 0
Australia
Phone 87274 0
+61 3 9966 9471
Fax 87274 0
Email 87274 0
andrew.chanen@orygen.org.au
Contact person for public queries
Name 87275 0
Prof Andrew Chanen
Address 87275 0
Orygen, The National Centre of Excellence in Youth Mental Health, Locked bag 10, Parkville, VIC 3052
Country 87275 0
Australia
Phone 87275 0
+61 3 9966 9471
Fax 87275 0
Email 87275 0
andrew.chanen@orygen.org.au
Contact person for scientific queries
Name 87276 0
Prof Andrew Chanen
Address 87276 0
Orygen, The National Centre of Excellence in Youth Mental Health, Locked bag 10, Parkville, VIC 3052
Country 87276 0
Australia
Phone 87276 0
+61 3 9966 9471
Fax 87276 0
Email 87276 0
andrew.chanen@orygen.org.au

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 trial-related participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
IPD available after 1/1/2024 until indefinitely
Available to whom?
Investigators whose proposed use of the data has been approved by an independent review committee.
Available for what types of analyses?
To achieve aims in the approved protocol
How or where can data be obtained?
Proposals can be submitted up to three years following article publication. Initial contact should be directed to an Executive Officer at
Orygen, The National Centre of Excellence in Youth Mental Health main office is located in Parkville, Victoria. Phone +61 (0) 3 99669574.
or via https://www.orygen.org.au/Contact/Contact-Us#ContactForm
Note: To gain access data, requestors will need to sign a data access agreement.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1290 0
Study protocol
Citation [1] 1290 0
Link [1] 1290 0
Email [1] 1290 0
andrew.chanen@orygen.org.au
Other [1] 1290 0
The study protocol will shortly be submitted for publication and we will make this available upon acceptance.
Attachment [1] 1290 0
Type [2] 4263 0
Statistical analysis plan
Citation [2] 4263 0
Link [2] 4263 0
Email [2] 4263 0
Other [2] 4263 0
The study statistical analysis plan will shortly be submitted for publication and we will make this available upon acceptance.
Attachment [2] 4263 0
Type [3] 4264 0
Informed consent form
Citation [3] 4264 0
Link [3] 4264 0
Email [3] 4264 0
andrew.chanen@orygen.org.au
Other [3] 4264 0
Available from recruitment start date by request
Attachment [3] 4264 0
Type [4] 4265 0
Ethical approval
Citation [4] 4265 0
Link [4] 4265 0
Email [4] 4265 0
andrew.chanen@orygen.org.au
Other [4] 4265 0
Available from recruitment start date by request
Attachment [4] 4265 0
Summary results
No Results