Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000363280
Ethics application status
Approved
Date submitted
27/02/2018
Date registered
9/03/2018
Date last updated
1/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of an Individual Placement and Support (IPS) prototype for young people aged 18-19 with mild and moderate mental health conditions developed by the Community Mental Health Service at Odyssey House in Christchurch, "Taking Charge",
Scientific title
Feasibility of an Individual Placement and Support (IPS) prototype for young people aged 18-19 with mild and moderate mental health conditions developed by the Community Mental Health Service at Odyssey House in Christchurch, "Taking Charge",
Secondary ID [1] 294165 0
None
Universal Trial Number (UTN)
U1111-1209-9221
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 306795 0
Condition category
Condition code
Mental Health 305901 305901 0 0
Other mental health disorders
Mental Health 305998 305998 0 0
Depression
Mental Health 305999 305999 0 0
Anxiety
Mental Health 306000 306000 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study design can be characterised as an open trial feasibility study (Ellison et al., 2015) designed to assess fidelity, integration of the adaptations, reach and retention, activities and outcomes, and cultural fit in an IPS prototype. Feasibility studies do not evaluate the impact of the intervention on the outcome of interest - that is left to the main study (Arain et al., 2010).
Setting
The setting for the prototype is Community Youth Mental Health Service (CYMHS) operated by Odyssey House in Christchurch.

The IPS prototype will be delivered at Odyssey House’s Ferry Road site in central Christchurch. This site does not have the stigma of being a drug and alcohol treatment centre. The site provides peer support, links to AOD and mental health services if needed and is the location of the IPS employment specialists and the ‘Take Charge co-ordinator’. The CYMHS clinical team also holds their meetings at the site. A Work and Income Community Link is nearby.
The ‘Taking Charge’ prototype will make a number of adaptations to IPS.
- The target group will be largely comprised of young benefit recipients with mild-to-moderate conditions (where IPS was developed for adults with severe disorder).
- Employment services will be partially integrated with mental health services (as not every participant will be under, or require, mental health services at the time of their participation).
- Employment assistance will be time limited (to 6-9 months depending on when the individual enrols in).
- Additional components will be added, including:
- group-based motivational workshops (that include elements of life-skills training and coaching participants in skills for understanding and coping with their condition)
- mentoring and social support, and mental health and addiction support as needed, provided by the Take Charge co-ordinator (in addition to assistance from an employment specialist)
- access to an individual flexi-fund (for direct purchasing of services or products to support movement into employment and job retention).
Delivery will acknowledge and consider the situation of each participant and use an approach that is appropriate, individualised and delivered in a manner sensitive participant needs. The service will be delivered in an environment that is positive and encourages achievement. Contact with participants will be formal, either one-to-one or a group situation and will include activities tailored to meet the individual participant’s needs.
CYMHS will deliver the programme for 3 client intakes.
Each intake of 15 young people will receive 5 one hour group workshops over three weeks. An employment specialist and Take Charge co-ordinator will then work with each participant individually to identify jobs that interest them and take steps to prepare for and find work. If the participant has not found work by the end of the prototype (6 to 9 months after), CYMHS will transition the participant back to the MSD Service Centre.
The employment specialist and Take Charge co-ordinator will be expected to have extensive local networks with support services, including counselling and budgeting services, employers, industry groups and training providers. The employment specialist will source vacancies from their own employer networks. The prototype will be delivered to a maximum of 45 participants over the prototype period (May 2018 to February 2019). CYMHS will continue to deliver on-going support to participants until February 2019.
Intervention code [1] 300455 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304940 0
IPS Fidelity
After 6 months, fidelity will be assessed using the IPS-25 Fidelity Scale (Becker, Swanson, Bond, & Merrens, 2011). This scale assesses adherence to the principles of supported employment. The IPS-25 has adequate inter-rater reliability and predictive validity (Bond et al, 2012; Kim et al., 2015) and is used to monitor quality of implementation of programs in New Zealand and internationally. A recent review provides evidence of moderate, yet important, predictive validity, but indicates that good fidelity may be necessary but not sufficient for good competitive employment outcomes (Locket et al., 2016).
Timepoint [1] 304940 0
one review 6 months after commencement
Primary outcome [2] 304941 0
Integration of adaptations - do IPS and additional components work well together?
A formative evaluation will be undertaken 4-6 months after implementation. It will be informed by document review, monitoring data, interviews and observation, and by existing literature on the effectiveness of the different components and best practice for their delivery
Timepoint [2] 304941 0
evaluation 4-6 months after commencement
Secondary outcome [1] 343677 0
Reach
Monitoring data wil be collected: date of birth; start date of accessing IPS services; attendance at workshops; the date of starting any voluntary work, paid employment or work experience, and the number of hours per week and where; support provided to help the person find work; flexi-fund payments made on the client’s behalf; other support services that referred to; end date/opt out of their enrolment (including reason). It does not include any clinical information
Timepoint [1] 343677 0
data collected monthly over 9 months
Secondary outcome [2] 343678 0
Cultural acceptability using a client satisfaction survey previously used by the provider of the service. The formative evaluation will also asses this through client interviews
Timepoint [2] 343678 0
formative evaluation 4-6 months after enrollment
Secondary outcome [3] 343777 0
work outcomes will be assessed using monitoring data
attendance at workshops; the date of starting any voluntary work, paid employment or work experience, and the number of hours per week and where; support provided to help the person find work; flexi-fund payments made on the client’s behalf; other support services that referred to; end date/opt out of their enrolment (including reason).
Timepoint [3] 343777 0
data collected monthly for nine months
Secondary outcome [4] 343954 0
retention
Monitoring data wil be collected: start date of accessing IPS services and date of exit
Timepoint [4] 343954 0
data collected monthly
Secondary outcome [5] 343955 0
Wellbeing
Timepoint [5] 343955 0
NZ WHOQOL bref questionnaire will be used at commencement, three months and six months to measure change in wellbeing

Eligibility
Key inclusion criteria
Participation will be voluntary. Participants will be invited to participate if they:
- are aged 18 or 19
- are in receipt of an MSD main benefit - either receiving Job Seeker Support – Health Condition, Injury or Disability (JS-HCID) or Supported Living Payment (SLP)
- have a Work and Income medical certificate indicating they have one or more of the following incapacity conditions that is ‘stress’, ‘depression’, ‘Other psychological/psychiatric’, ‘ drugs’ or ‘alcohol’
- are registered with a Work and Income Service Centre in the Canterbury Region.
Eligible clients may have a mixture of health conditions which may include varying levels of anxiety, depression or alcohol and substance abuse
Minimum age
18 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients will be excluded by MSD if they are known to have significant co-occurring physical health problems or disabilities, have bipolar disorder or schizophrenia, if they are pregnant, or if there is a trespass order against them. Clients who after referral by MSD are assessed by CYMHS as having a severe mental health condition will also be excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Methods of Assessment
Methods of assessment are:
- an IPS Fidelity Review of the prototype, with an added focus on gathering client and clinician perspectives on cultural relevance and cultural acceptability
- a formative evaluation to assess the integration of the adaptations to IPS, with a focus on cultural acceptability
- analysis of monitoring data
- assessment of participant wellbeing using the WHOQOL tool (brief version)
- an anonymous client satisfaction survey that allows satisfaction with the prototype,
IPS Fidelity Review
After 6 months, fidelity will be assessed using the IPS-25 Fidelity Scale (Becker, Swanson, Bond, & Merrens, 2011). This scale assesses adherence to the principles of supported employment. The IPS-25 has adequate inter-rater reliability and predictive validity (Bond et al, 2012; Kim et al., 2015) and is used to monitor quality of implementation of programs in New Zealand and internationally. A recent review provides evidence of moderate, yet important, predictive validity, but indicates that good fidelity may be necessary but not sufficient for good competitive employment outcomes (Locket et al., 2016).
Reviewers follow a set protocol with instructions for preparing sites for the visit and sample interview questions. Fidelity items are rated on a five-point scale based on the degree of implementation ranging from 1 = no implementation to 5 = full implementation. Recommendations for improving fidelity are provided for each item scored lower than 5.
Data collection procedures include:
- team meeting observations: both a mental health treatment team and the vocational unit
- individual interviews: the IPS coordinator, the agency’s clinical director, the executive director, mental health practitioners (i.e., case managers), a medical director or psychiatrist, and employment specialists
- interview with a small group of clients who have received IPS services – participation will be voluntary
- shadowing employment specialists individually while they conduct job development (e.g., contacting employers for community-based job searches)
- clinical record reviews (Becker, Swanson, Bond, & Merrens, 2011).
A provider with experience in conducting IPS Fidelity Reviews and trained reviewers will be commissioned to conduct the review.
Reviewers will provide a report to CYMHS including observations, assessments and recommendations for programme improvement. The report will be sent directly to the team within 2 or 3 weeks, so they can make immediate improvements. The report will form part of the evaluation of the prototype.
The work commissioned from the Provider will include additional questions that focus on gathering client and clinician perspectives on cultural relevance and cultural acceptability, and assessing the need for adaptations in the full implementation to ensure cultural fit in the New Zealand context.
Formative evaluation
The formative evaluation will be undertaken 4-6 months after implementation. An academic research team with expertise in youth mental health, youth development and research involving Maori will be commissioned to conduct the evaluation. Suitable teams are currently being approached for expressions of interest in conducting the work.
The formative evaluation will have a particular focus on the adaptations to IPS made by the prototype. It will document the prototype as it is being delivered in practice, assess whether the IPS and the added components work well together, and make any recommendations for improvement. It will be informed by document review, monitoring data, interviews and observation, and by existing literature on the effectiveness of the different components and best practice for their delivery.
Like the IPS fidelity review, the formative evaluation will have a focus on gathering perspectives on cultural relevance and cultural acceptability of the components, and assessing the need for adaptations in the full implementation to ensure cultural fit in the New Zealand context.
Monitoring data
Monitoring data will be collected for the evaluation.
As part of contract monitoring, identifiable information on MSD clients receiving the prototype will be required and will be shared by CYMHS with MSD, with the informed consent of clients. This information is limited to name; date of birth; start date of accessing IPS services; attendance at workshops; the date of starting any voluntary work, paid employment or work experience, and the number of hours per week and where; support provided to help the person find work; end date/opt out of their enrolment (including reason). It does not include any clinical information.
Together with existing administrative data held by MSD, this information will be used by the research team to generate de-identified measures of reach, activities and short-term outcomes, and retention for the prototype. Examples of these measures include the following:
Reach:
- Number and proportion of people in the potentially eligible target group who are invited to a promotional seminar
- Number and proportion of people invited to a promotional seminar to learn about IPS who:
- attend the seminar
- provide informed consent to participate in the IPS prototype
- provide informed consent to participate and attend the first IPS workshop (active participants)
- Numbers excluded due to unsuitability by reason and stage at which this occurs
- Characteristics of active participants (eg. age, gender, ethnic group, benefit type benefit duration and incapacity reasons recorded by MSD) compared to those of all people in the potentially eligible target group
Activities and short-term outcomes within 1, 3 and 6 months of enrolment:
- Number and percentage of participants taking steps towards work (e.g. engagement in job search activities; discussions with employers)
- Number and percentage of participants in voluntary work, paid employment or work experience for 8, 15 and 30 hours or more per week
- The average amount of one-on-one support (time) the Employment specialist spends with each participant on a monthly basis.
Retention within 1, 3 and 6 months of enrolment:
- Number and percentage of participants leaving the IPS prototype by reason (e.g. work, education/training, moved out of area, illness, didn’t like the programme)
Assessment of participant quality of life
For the prototype we are interested in who is engaging in the intervention and assessing their quality of life is a component of this. We are also interested in assessing whether there are improvements in participants’ quality of life over time from their perspective. Using the WHOQOL (World Health Organization Quality Of Life) will allow us to do this.
The measurement instruments are designed to measure the extent to which people, irrespective of their health status, feel satisfied with their health and well-being. Quality of life as defined by WHO is a multifaceted concept. The instruments produce a descriptive profile of a person’s quality of life, not a single score or index. The WHOQOL instruments are well validated and available free of charge to professionals. We will seek permission from New Zealand WHOQOL Group to use the New Zealand version of the WHOQOL brief tool.
WHOQOL tools are used in health care to help the professional make the best choices for patients and clients and monitor any change in quality of life over the course of treatment and recovery. In this intervention Odyssey House will administer the New Zealand version of the WHOQOL brief tool when participants enter the intervention and at three and six months after this date. Permission will be sought from participants for Odyssey House to use the tool to assess well-being and to use the information to inform what they do with the participants.
Consent will also be sought from participants to use the information collected from the survey in the evaluation of the prototype. However, evaluators will only receive de-identified survey data.
Client satisfaction survey
A brief client satisfaction survey will be administered to clients participating in the IPS service 6 months after the prototype commences. Participation will be voluntary and responses will be anonymous.
While numbers in the prototype will not be large enough to allow significant differences in responses between ethnic groups to be detected, results will be used to assess the acceptability of the prototype to clients overall and for the main ethnic groups, including its cultural acceptability. Given the relatively small size of the prototype, examination of ethnic differences in satisfaction will be limited to comparison the overall pattern of responses, rather than the responses to individual items.
Few previous studies of IPS are known to have assessed client satisfaction, and no standardised instrument exists (Viering et al., 2015). Questions asked will be modified versions of questions in the Health Quality and Safety Commission Primary Care Patient Experience Survey, and questions used in other New Zealand studies that have sought participant feedback on cultural acceptability.
We also intend to include a question about the work aspirations of participants. There is a need for better information on the alignment of the IPS service with the work goals of the client group (Essen, 2012).
Current thinking is that the survey will be given to clients by their employment specialist together with a sealable stamped envelope addressed to the Research Team. Clients will be told that the survey is voluntary and their response won’t be able to be able to be linked back to them. They will be invited to take a few minutes in a private space to fill out the survey and seal the envelope before handing to the employment specialist for posting, or take the survey away and fill it in and post it later.
A limitation of this approach is that results might be influenced by the employment specialist handing out the questionnaire and being present while clients answer the questions (Viering et al., 2015). However we expect that this approach will be the best way of ensuring clients understand the purpose and relevance of the survey, and will result in a lower sense of intrusion and a higher rate of forms returned than other possible methods (such as being contacted by telephone by a researcher who is not known to the client, or receiving a survey form by post or email).
An on-line survey administered during a meeting with the employment specialist will be considered as an alternative means of administration, but would present a similar risk of results being influenced.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/06/2018
Actual
Date of last participant enrolment
Anticipated
1/11/2018
Actual
Date of last data collection
Anticipated
29/03/2019
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 9629 0
New Zealand
State/province [1] 9629 0
Christchurch

Funding & Sponsors
Funding source category [1] 298801 0
Government body
Name [1] 298801 0
Ministry of Social Development
Country [1] 298801 0
New Zealand
Primary sponsor type
Government body
Name
Ministry of Social Development
Address
PO Box 1556
Wellington 6140
Country
New Zealand
Secondary sponsor category [1] 297991 0
None
Name [1] 297991 0
Address [1] 297991 0
Country [1] 297991 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299746 0
Health and Disabililty Ethics Committee (HDEC)
Ethics committee address [1] 299746 0
Ethics committee country [1] 299746 0
New Zealand
Date submitted for ethics approval [1] 299746 0
01/03/2018
Approval date [1] 299746 0
30/04/2018
Ethics approval number [1] 299746 0

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

Contacts
Principal investigator
Name 81442 0
Ms Fleur McLaren
Address 81442 0
Ministry of Social Development
PO Box 1556
Wellington 6140
Country 81442 0
New Zealand
Phone 81442 0
+64 04 9163406
Fax 81442 0
Email 81442 0
fleur.mclaren002@msd.govt.nz
Contact person for public queries
Name 81443 0
Fleur McLaren
Address 81443 0
Ministry of Social Development
PO Box 1556
Wellington 6140
Country 81443 0
New Zealand
Phone 81443 0
+64 04 9163406
Fax 81443 0
Email 81443 0
fleur.mclaren002@msd.govt.nz
Contact person for scientific queries
Name 81444 0
Fleur McLaren
Address 81444 0
Ministry of Social Development
PO Box 1556
Wellington 6140
Country 81444 0
New Zealand
Phone 81444 0
+64 04 9163406
Fax 81444 0
Email 81444 0
fleur.mclaren002@msd.govt.nz

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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