Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000007235
Ethics application status
Approved
Date submitted
13/11/2017
Date registered
10/01/2018
Date last updated
10/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the New South Wales Premier's Youth Initiative - A randomised controlled trial to prevent youth homelessness.
Scientific title
Premier’s Youth Initiative — An intervention to prevent homelessness for youth leaving out-of-home care
Secondary ID [1] 293306 0
AEARCTR-0002563
Universal Trial Number (UTN)
U1111-1204-7434
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Youth homelessness 305387 0
Condition category
Condition code
Public Health 304673 304673 0 0
Other public health
Other 304674 304674 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Premier's Youth Initiative (PYI)

PYI aims to reduce youth homelessness for young people leaving out-of-home care (OOHC) in participating regions in New South Wales (NSW). This study aims to investigate whether PYI is effective in preventing or delaying homelessness within the target population.
The intervention will consist of multiple components:
- A personal advisor who will support the young person during their transition from OOHC
- Education and employment mentoring
- Accommodation support via subsidised head-leased properties
- Transitional support to assist young people to develop their capacity to independently manage their accommodation needs.

PYI is designed as individualised support including ongoing support through a personal advisor, education and/or employment mentoring and additional services. A key element of PYI is hereby the focus on evidence-informed practice integration, i.e., that youth are connected to services based on their needs. Services applying evidence-informed practice will be prioritised. A main focus of PYI is to build young people's capacity to live independently.

The initiative was designed by the NSW Department of Family and Community Services (FACS) and the intervention will be delivered by case workers from service provider agencies in collaboration with the personal advisors mentioned above. Hence, the intervention will be delivered as part of the case and support work together with in-person contact with the personal advisor. Additional services will be delivered by provider agencies and mentors as identified in the needs assessment, the leaving care plan and the goals set for the young person leaving care.

Duration: The duration of the individual intervention will depend on when children become eligible to participate in the study and the particular needs identified. Overall, the trial is expected to commence in early January 2018 and continue until June 2020.

Worker training:
Trained consent workers (case workers or youth service workers) will be asked to consent eligible youth to participate in the study and conduct the baseline data collection. To facilitate the consent process and minimise the likelihood of errors during data collection, we will ask case workers to attend a training session on "Obtaining consent and measuring client outcomes". Training is delivered between September 2017 and February 2018 and is usually conducted on a single day at each site.

Participant incentives:
Following usual practice, participants in both the PYI intervention and BAU groups will receive a small contribution, in form of vouchers, for their participation and in compensation for their time. We anticipate that some youth will be difficult to engage in subsequent interviews. To acknowledge their effort and time to continue their participation, the value will increase for the second and third round of data collection.

Process evaluation:
The PYI practice model will be refined as part of a process evaluation which will be based on three measures: (1) client satisfaction, (2) implementation fidelity, and (3) perceived barriers and facilitators to implementation. The aim of the process evaluation is to ensure adherence to the PYI practice model and increase program fidelity.

The client satisfaction will be measured during three rounds in the first year of the outcomes evaluation to assess the perceived quality of service and whether clients feel that their needs are met. Expected sample size for this component will be six clients.
Additionally, PYI service providers will be interviewed three times during the first year of the PYI implementation to systematically detect barriers to the implementation of PYI. Target sample size will be six participants working directly with PYI clients, six supervisors of frontline staff and six participants from senior management. The first two components will include semi-structured interviews, conducted by experienced research staff, to collect data.
The third component will focus on whether PYI practice model was implemented as intended. For this analysis, information will be collected using fidelity check-lists that will be administered on a quarterly basis.
Information collected as part of the process evaluation will feed directly into a continuous quality improvement cycle in form of quarterly recommendations to be implemented by PYI service providers.
Intervention code [1] 299565 0
Prevention
Comparator / control treatment
Youth in the control group will receive usual leaving and aftercare services delivered by service provider agencies in participating regions. Leaving care support is targeted at young persons aged 15-17 years while aftercare support focuses on youth aged 18-24 years.

Usual leaving and aftercare support consists of three components:
- Development of a leaving care plan
- Offer of follow-up support at regular intervals after exit from care
- Financial assistance

As part of usual care it is usually the responsibility of the provider agency to develop the leaving care plan and create link with accommodation services,
Control group
Active

Outcomes
Primary outcome [1] 303888 0
Was the client ever homeless in the trial period?

Instrument (adapted from Courtney et al.,, 2017)
Survey question: In the last 12 months have you ever been homeless for one night or longer - that is, have you slept in a homeless refugee or accommodation or in a place where people weren't meant to sleep because you didn't have a place to stay?

Answer option:
• Yes
• No
• Don’t know
• Refused

Reference: Courtney M, Okpych NJ, Napolitano L, et al. (2017). California Youth transition to adulthood Study. https://ssascholars.uchicago.edu/calyouth/content/study-overview
Timepoint [1] 303888 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Primary outcome [2] 303889 0
Has the client engaged homelessness services?

Instrument:
This outcome will be drawn from the administrative data. Each individual’s response will be coded and analysed as a binary variable, where if the individual has engaged with homelessness services, they are coded as TRUE and FALSE otherwise.
Timepoint [2] 303889 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [1] 340363 0
How often was the client homeless?

Instrument (Adapted from Courtney et al., 2017):
Survey question: In the last 12 months, how many separate times have you found yourself homeless for one or more nights?

Answer options:
• Integer (1 – 9)
• 10+ times
• Don’t know
• Refused
• Skipped (answered No to having been homeless)
Timepoint [1] 340363 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [2] 340364 0
How long was the clients longest homeless period?

Instrument (adapted from Courtney et al., 2017)
Survey question: In the last 12 months, how long in days was the longest period of time you spent homeless?
Answer options:
• Integer (1 – 365)
• Don’t know
• Refused
• Skipped (answered No to having been homeless)
Timepoint [2] 340364 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [3] 340426 0
How long was the client homeless in total?

Instrument (adapted from Courtney et al., 2017):
Survey question: In the last 12 months, how many total days did you spend homeless?
Answer options:
• Between 1 day and 3 days
• More than 2 days and up to 1 week
• More than 1 week and up to 2 weeks
• More than 2 weeks and up to 1 month
• More than 1 month and up to 3 months
• More than 3 months and up to 6 months
• More than 6 months and up to 9 months
• More than 9 months and up to 12 months
• 12 months (the entire time)
• Don’t know
• Refused
• Skipped (answered No to having been homeless)
Timepoint [3] 340426 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [4] 340427 0
How is the client’s health?

Instrument (adapted from Courtney et al., 2017):
Survey question: In general, how is your health? Would you say it is excellent, very good, good, fair, or poor?
Answer options:
• Excellent
• Very Good
• Good
• Fair
• Poor
• Don’t Know
Timepoint [4] 340427 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [5] 340428 0
Did the client ever receive psychological services?

Instrument (adapted from Courtney et al., 2017):
Survey question: In the past year, have you received psychological or emotional counselling?
Answer options:
• Yes
• No
• Don’t know
• Refused
Timepoint [5] 340428 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [6] 340429 0
Did the client ever receive alcohol and drug rehabilitation services?

Instrument (adapted from Courtney et al., 2017):
Survey question: Have you received treatment for an alcohol or substance abuse problem during the past year?
Answer options:
• Yes
• No
• Don’t know
• Refused
Timepoint [6] 340429 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [7] 340431 0
Was the client robbed or assaulted?

Instrument (adapted from Courtney et al., 2017):
Survey question: In the last 12 months, were you robbed or assaulted?
Answer options:
• Yes
• No
• Don’t know
• Refused
Timepoint [7] 340431 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [8] 340433 0
Was the client in a violent relationship?

Instrument (adapted from Courtney et al., 2017):
Survey question: In the last 12 months, were you:
Answer options:
• In a physically violent relationship
• In a non-physically violent relationship
• Not in a relationship
• Don’t know
• Refused
Timepoint [8] 340433 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [9] 340667 0
Does the client show signs of mental health issues?

Instrument:
DSM 5 Self Rated Level 1 Cross-Cutting Symptom Measure - Adult (American Psychiatric Association): Aggregated scores across 23 items.
Timepoint [9] 340667 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [10] 340668 0
Does the client have functional social support?

Instrument:
Total score across items of the Duke_UNC Functional Support Questionnaire (Broadhead, et al., 1988)

Reference: Broadhead WE, Gehlbach, SH, De Gruy FV, Kaplan BH. (1988). The Duke-UNC Functional Social Support Questionnaire. Medical Care, 26(7), p 709-723.
Timepoint [10] 340668 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [11] 341304 0
How is the clients’ mental well-being?

Instrument:
Warwick-Edinburgh Mental Wellbeing Scale (Taggart, Steward-Brown & Parkinson, 2015).

References:
Taggart F, Stewart-Brown S, Parkinson J (2015). Warwick–Edinburgh Mental Well-being Scale (WEMWBS) User Guide Version 2. Glasgow: NHS Health Scotland.
Timepoint [11] 341304 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [12] 341305 0
How is the client’s sense of self-efficacy?

Instrument:
General Self Efficacy Scale (Schwarzer & Jerusalem, 1995)

References:
Schwarzer R, & Jerusalem M (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user’s portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON.
Timepoint [12] 341305 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [13] 341306 0
How is the client’s general well-being?

Instrument:
Personal Wellbeing Index - Adult (The International Wellbeing Group, 2013).

References:
The International Wellbeing Group (2013). Personal Wellbeing Index: 5th Edition. Melbourne: Australian Centre on Quality of Life, Deakin University.
Timepoint [13] 341306 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [14] 341307 0
Is the client currently engaged in education?

Instrument (adapted from Courtney et al., 2017):
Survey question: In the last 12 months, have you been enrolled in school or higher education (e.g. vocational training (TAFE) or university) full-time, part-time or have you not been enrolled in school?
Answer options:
• Yes, enrolled full-time
• Yes, enrolled part-time
• Not in school / vocational training (TAFE) or university
• Don’t know
Timepoint [14] 341307 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [15] 341308 0
Has the client completed high school?

Instrument (adapted from Courtney et al., 2017):
Survey question: Have you completed high school?
Answer options:
• Yes
• No
• Don’t know
• Refused
Timepoint [15] 341308 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [16] 341309 0
Has the client been in employment in the last 12 months?

Instrument (adapted from Courtney et al., 2017):
Survey question: Please count only jobs that lasted for three months or more, and at which you worked at least 10 hours a week.
In the last 12 months did you work for pay?
Answer options:
• Yes
• No
• Don’t know
• Refused
Timepoint [16] 341309 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [17] 341310 0
Is the client currently working? If so, how much?

Instrument (adapted from Courtney et al., 2017):
Survey question: How many hours are you currently working per week?
Answer options:
• 0 hours
• 1 - 5 hours
• 6 – 10 hours
• 11 – 15 hours
• 16 – 20 hours
• 21 – 25 hours
• 26 – 30 hours
• 31 – 35 hours
• 36- 40 hours
• 41 – 45 hours
• 46 – 50 hours
• Greater than 50 hours
• Don’t know
• Refused
Timepoint [17] 341310 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [18] 341311 0
How much is the client currently earning (if they are in work)?

Instrument (adapted from Courtney et al., 2017):
Survey question: What are your usual fortnightly earnings on this job before taxes or other deductions?
Answer options:
• $0.00 – $699.99 Fortnightly
• $700.00 – $999.99 Fortnightly
• $1,000.00 – $1199.99 Fortnightly
• $1,200.00 – $1499.99 Fortnightly
• $1,500.00 – $1699.99 Fortnightly
• $1,700.00 – $1999.99 Fortnightly
• $2,000.00 – $2499.99 Fortnightly
• $2,500.00 – $3199.99 Fortnightly
• $3,200.00 – $3999.99 Fortnightly
• $4,000.00 or more Fortnightly
• Don't know
• Refused
Timepoint [18] 341311 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.
Secondary outcome [19] 341312 0
How satisfied is the client with their employment?

Instrument (adapted from Courtney et al., 2017):
Survey question: How satisfied are you with this job, as a whole? Would you are:
Answer options:
• Extremely satisfied
• Satisfied
• Neither satisfied nor dissatisfied
• Dissatisfied
• Extremely dissatisfied
• Don’t know
• Refused
Timepoint [19] 341312 0
Initial assessment: Within 6 months of participants' 17th birthday.

Second assessment: Within 2 months prior to participants' 18th birthday OR 2 months prior to exiting OOHC.

Third assessment: Within 2 months prior to participants' 19th birthday OR 12 months after transitioning from OOHC.

Eligibility
Key inclusion criteria
- Youth living in a participating region: Central Coast, Hunter New England, Illawarra Shoalhaven, Nepean Blue Mountains, South Western Sydney, Southern NSW, Western NSW.
- are at least 16.75 years old at time of recruitment
- are not older than 17.5 years at time of recruitment

additionally meet one or more of the following criteria:
- leaving residential OOHC,
- leaving OOHC with placement instability,
- leaving a permanent OOHC placement, and
- leaving OOHC after being in care 12 months or longer.
Minimum age
16 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Youth is not eligible to transition to independent living
- Youth is unable to provide informed consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible clients will be identified using de-identified administrative records of children in OOHC at regular intervals over the course of the recruitment period.

A list of identified eligible clients will be made available to service providers. These lists will be region-specific and will only be available to service providers within the corresponding region. Allocation of clients will use a stratified randomisation process at regular intervals.

Eligible clients will be invited by case workers to participate in the study. Dedicated consent workers will then attend a meeting between case worker and client. During this session, informed consent will be obtained. If the young person consents to participate in the study, the consent worker will conduct a baseline survey at soon as possible but latest within 30 days of consent being provided.

Consent forms and baseline surveys will be scanned and forwarded to the research team via secure data transfer. Once scanned versions of the consent form and baseline survey have been received by researchers, the allocation outcome will be made available to case workers. This approach ensures that nobody outside the evaluation team will have access to allocation outcomes prior to received consent and baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of intervention allocation will be conducted at the beginning of the trial and then at regular intervals throughout the trial.
The randomisation procedures have been designed to ensure that samples are balanced. Samples will be stratified by a number of variables to ensure balancing on key characteristics.
We will then test whether treatment and control differ by a subset of characteristics, using a simple t-test:
The resulting t-statistic for each of these tests will be recorded, and the largest t-statistic will be used as our measure of balance for the allocation. We will conduct this randomisation 10,000 times and the allocation with the smallest imbalance between the groups will be used as the allocation for the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/01/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297931 0
Government body
Name [1] 297931 0
New South Wales Department of Family & Community Services
Country [1] 297931 0
Australia
Primary sponsor type
Other
Name
Centre for Evidence and Implementation
Address
33 Lincoln Square South, Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 296993 0
Commercial sector/Industry
Name [1] 296993 0
Behavioural Insights Team
Address [1] 296993 0
Macquarie House, Level 13, 167 Macquarie Street, Sydney NSW 2000
Country [1] 296993 0
Australia
Secondary sponsor category [2] 297041 0
University
Name [2] 297041 0
The University of Melbourne, School of Health Sciences, Department of Social Work
Address [2] 297041 0
Level 7, 161 Barry Street, Carlton VIC 3053
Country [2] 297041 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298977 0
Behavioural and Social Sciences Human Ethics Sub-Committee at The Univeristy of Melbourne
Ethics committee address [1] 298977 0
Ethics committee country [1] 298977 0
Australia
Date submitted for ethics approval [1] 298977 0
Approval date [1] 298977 0
16/10/2017
Ethics approval number [1] 298977 0
1749520

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78866 0
A/Prof Robyn Mildon
Address 78866 0
Centre for Evidence and Implementation (CEI), 33 Lincoln Square South, Carlton VIC 3053
Country 78866 0
Australia
Phone 78866 0
+61 429 513 217
Fax 78866 0
Email 78866 0
[email protected]
Contact person for public queries
Name 78867 0
David Taylor
Address 78867 0
Centre for Evidence and Implementation (CEI), 33 Lincoln Square South, Carlton VIC 3053
Country 78867 0
Australia
Phone 78867 0
+61 429 513 217
Fax 78867 0
Email 78867 0
[email protected]
Contact person for scientific queries
Name 78868 0
David Taylor
Address 78868 0
Centre for Evidence and Implementation (CEI), 33 Lincoln Square South, Carlton VIC 3053
Country 78868 0
Australia
Phone 78868 0
+61 429 513 217
Fax 78868 0
Email 78868 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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