Data

INVEST: Individualised vocational support for youth with borderline personality disorder: A randomised controlled trial

Orygen

Dataset description

This single-blind, parallel-groups, randomised controlled trial evaluated the effectiveness of adding IPS to an evidence-based early intervention programme for Borderline Personality Disorder, with the aim of improving vocational outcomes. The randomisation is stratified by gender and age and uses random permuted blocks. The interventions are 39 weeks of either IPS, or 'usual vocational services' (UVS). Participants comprised of 108 help-seeking young people (aged 15-25 years) with three or more DSM-5 Borderline Personality Disorder features and a desire to study or work, recruited from the Helping Young People Early (HYPE) early intervention programme for Borderline Personality Disorder at Orygen, in Melbourne, Australia. All participants will receive the HYPE intervention. After baseline assessment, staff who are blind to the intervention group allocation will conduct assessments at 13, 26, 39 and 52 weeks. At the 52-week primary endpoint, the primary outcome is the number of days in mainstream education/employment since baseline. Secondary outcomes include the cost-effectiveness of the intervention, quality of life, and Borderline Personality Disorder severity.
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Source Study

Purpose

Treatment

Phase

Not Applicable

Funding

Government body,National Health and Medical Research Council

Scientific enquiries

Prof Andrew Chanen

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 ....
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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

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

Can healthy volunteers participate?

No

 

Population

Sample Size    88

Min. age    15 Years

Max. age    25 Years

Sex    Both males and females

Condition category    Borderline personality disorder

Condition code    Mental Health

Intervention

Intervention code Other interventions

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 ment ....
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Comparison

Control group Active

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 o ....
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Outcomes

Outcome: 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.
Timep ....

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Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

Data will be available immediately following publication of the main results for an indefinite time.

When will data be available?

IPD available after 1/1/2024 until indefinitely

Available to whom?

Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data sharing policy

Available for what types of analyses?

To any type of analyses. Assessed on a case-by-case basis.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au