Individual Placement and Support for Patients With Offending Histories

Study Overview
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Brief Summary
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The overall aim of the study is to assess the feasibility of conducting a Randomized Controlled Trial (RCT) to evaluate the effectiveness of Individual Placement and Support (IPS) in improving employment rates and associated psychosocial outcomes in forensic psychiatric populations.

Detailed Description
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This is a feasibility trial which aims to assess the feasibility of conducting a full Randomized Controlled Trial (RCT) to evaluate the effectiveness of Individual Placement and Support (IPS) in improving employment rates and associated psychosocial outcomes in forensic psychiatric populations. Given that IPS is a complex intervention, the design of this study has drawn from the principles set out in the UK Medical Research Council (MRC) Guidance on developing and evaluating complex interventions by defining three major research strands in order to achieve the specific objectives of the study as follows: A. Implementation of IPS in community forensic services: The specific objective of this strand is to embed the IPS model in the community forensic services in which the feasibility study will be carried out (aided by an IPS Expert), by bringing an employment specialist into clinical teams, raising awareness about IPS within the organization, forming links with IPS services in the area and developing links with employers, as well as conducting IPS fidelity reviews. B. Feasibility Cluster Randomized Controlled Trial (RCT): The specific objectives of this strand are to estimate the parameters required to design a full RCT including: Means and standard deviations of the key outcome measures in order to benchmark potential effect sizes and enable sample size calculations. The feasibility of randomization, recruitment and retention rates to the IPS and controls; The suitability of the key outcome measures with respect to: reliability, acceptability, and distribution of the scores. C. Process Evaluation: This will be carried out in parallel with the other two strands to meet other specific objectives by using the following methods: Qualitative interviews with staff to identify the structural, legal, organizational and individual-level to barriers and facilitators to implementation of IPS in community forensic services. Fidelity Reviews to assess the extent to which the services follow the principles of IPS and to assess how well the employment specialist functions within the community forensic services. Qualitative interviews with patients assigned to IPS in order to assess their general views of IPS, benefits from participating, disadvantages from or dislikes about participating and barriers and facilitators to implementation.

Official Title
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Individual Placement and Support (IPS) for Patients With Offending Histories: Feasibility of an Evidence-based Approach in Forensic Mental Health Settings

Conditions
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Employment, Supported, Treatment as Usual

Intervention / Treatment
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* Other: Individual Placement and Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over the age of 18 years Patients (females and males) on the caseload of the community forensic services Exclusion Criteria: Patients unable to provide informed consent Patients not eligible to work in the UK Patients currently in open employment Patients who do not wish to work

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual Placement and Support<br>Individual Placement and Support | Other: Individual Placement and Support<br>* Individual Placement and Support is a form of supported employment.<br>|
| No Intervention: Treatment as Usual<br>Treatment as Usual is comprised of routine clinical care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Open Employment: Proportion of people in open employment | Proportion of people in open employment at 12 month follow-up | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hours worked | Number of hours worked at 12 month follow-up | 12 Months | 
| Mental health as measured using the Brief Psychiatric Rating Scale (BPRS) | Measured using the Brief Psychiatric Rating Scale (BPRS) | Baseline, 6 and 12 Months | 
| Social Functioning as measured using the Social Functioning Questionnaire (SFQ) | Measured using the Social Functioning Questionnaire (SFQ) | Baseline, 6 and 12 Months | 
| Self-Esteem as measured using the Rosenberg's Self Esteem Scale | Measured using the Rosenberg's Self Esteem Scale | Baseline, 6 and 12 Months | 
| Work Limitations as measured using the Work Limitation Questionnaire | Measured using the Work Limitation Questionnaire | Baseline, 6 and 12 Months | 
| Quality of life as measured using SF-12v2 | Health-related quality of life as measured using SF-12v2 | Baseline, 6 and 12 Months | 
| Economic Costing as measured using the Client Service Receipt Inventory (CSRI) | Measured using the Client Service Receipt Inventory (CSRI) | Baseline, 6 and 12 Months | 
| Re-offending rates | Re-offending rates | Baseline and 18 Months | 
| Number of days in open employment | Number of days in open employment at 12 months | 12 months | 
| Quality of life as measured using the EQ5-D | Health-related quality of life as measured using the EQ5-D | Baseline, 6 and 12 months |