Overview

This trial is active, not recruiting.

Conditions employment, supported, treatment as usual
Treatment individual placement and support
Sponsor Nottinghamshire Healthcare NHS Trust
Collaborator University of Nottingham
Start date March 2016
End date September 2017
Trial size 18 participants
Trial identifier NCT02442193, KHALIFA/020415, PB-PG-1013-32093

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Individual Placement and Support
individual placement and support
Individual Placement and Support is a form of supported employment.
(No Intervention)
Treatment as Usual is comprised of routine clinical care.

Primary Outcomes

Measure
Open Employment: Proportion of people in open employment
time frame: 12 Months

Secondary Outcomes

Measure
Number of hours worked
time frame: 12 Months
Mental health as measured using the Brief Psychiatric Rating Scale (BPRS)
time frame: Baseline, 6 and 12 Months
Social Functioning as measured using the Social Functioning Questionnaire (SFQ)
time frame: Baseline, 6 and 12 Months
Self-Esteem as measured using the Rosenberg's Self Esteem Scale
time frame: Baseline, 6 and 12 Months
Work Limitations as measured using the Work Limitation Questionnaire
time frame: Baseline, 6 and 12 Months
Quality of life as measured using SF-12v2
time frame: Baseline, 6 and 12 Months
Economic Costing as measured using the Client Service Receipt Inventory (CSRI)
time frame: Baseline, 6 and 12 Months
Re-offending rates
time frame: Baseline and 18 Months
Number of days in open employment
time frame: 12 months
Quality of life as measured using the EQ5-D
time frame: Baseline, 6 and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Individual Placement and Support (IPS) for Patients With Offending Histories: Feasibility of an Evidence-based Approach in Forensic Mental Health Settings
Principal investigator Najat R Khalifa, DM
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Nottinghamshire Healthcare NHS Trust.