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Individual Placement and Support for Patients With Offending Histories

Not Applicable
Terminated
Conditions
Employment, Supported
Treatment as Usual
Interventions
Other: Individual Placement and Support
Registration Number
NCT02442193
Lead Sponsor
Nottinghamshire Healthcare NHS Trust
Brief Summary

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

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
18
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Individual Placement and SupportIndividual Placement and SupportIndividual Placement and Support
Primary Outcome Measures
NameTimeMethod
Open Employment: Proportion of people in open employment12 Months

Proportion of people in open employment at 12 month follow-up

Secondary Outcome Measures
NameTimeMethod
Number of hours worked12 Months

Number of hours worked at 12 month follow-up

Re-offending ratesBaseline and 18 Months

Re-offending rates

Number of days in open employment12 months

Number of days in open employment at 12 months

Quality of life as measured using the EQ5-DBaseline, 6 and 12 months

Health-related quality of life as measured using the EQ5-D

Self-Esteem as measured using the Rosenberg's Self Esteem ScaleBaseline, 6 and 12 Months

Measured using the Rosenberg's Self Esteem Scale

Mental health as measured using the Brief Psychiatric Rating Scale (BPRS)Baseline, 6 and 12 Months

Measured using the Brief Psychiatric Rating Scale (BPRS)

Social Functioning as measured using the Social Functioning Questionnaire (SFQ)Baseline, 6 and 12 Months

Measured using the Social Functioning Questionnaire (SFQ)

Quality of life as measured using SF-12v2Baseline, 6 and 12 Months

Health-related quality of life as measured using SF-12v2

Work Limitations as measured using the Work Limitation QuestionnaireBaseline, 6 and 12 Months

Measured using the Work Limitation Questionnaire

Economic Costing as measured using the Client Service Receipt Inventory (CSRI)Baseline, 6 and 12 Months

Measured using the Client Service Receipt Inventory (CSRI)

Trial Locations

Locations (1)

Nottinghamshire NHS Foundation Trust

🇬🇧

Nottingham, United Kingdom

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