Treatment as Usual Clinical Trial
Official title:
Individual Placement and Support (IPS) for Patients With Offending Histories: Feasibility of an Evidence-based Approach in Forensic Mental Health Settings
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.
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:
1. Means and standard deviations of the key outcome measures in order to benchmark
potential effect sizes and enable sample size calculations.
2. The feasibility of randomization, recruitment and retention rates to the IPS and
controls;
3. 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:
1. 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.
2. 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.
3. 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.
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