Individual Placement and Support for Patients With Offending Histories (IPSOH)
|ClinicalTrials.gov Identifier: NCT02442193|
Recruitment Status : Terminated (Terminated by the funder due to low recruitment rates.)
First Posted : May 13, 2015
Last Update Posted : February 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Employment, Supported Treatment as Usual||Other: Individual Placement and Support||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Individual Placement and Support (IPS) for Patients With Offending Histories: Feasibility of an Evidence-based Approach in Forensic Mental Health Settings|
|Actual Study Start Date :||September 15, 2015|
|Actual Primary Completion Date :||September 15, 2017|
|Actual Study Completion Date :||November 3, 2017|
Experimental: Individual Placement and Support
Individual Placement and Support
Other: Individual Placement and Support
Individual Placement and Support is a form of supported employment.
No Intervention: Treatment as Usual
Treatment as Usual is comprised of routine clinical care.
- Open Employment: Proportion of people in open employment [ Time Frame: 12 Months ]Proportion of people in open employment at 12 month follow-up
- Number of hours worked [ Time Frame: 12 Months ]Number of hours worked at 12 month follow-up
- Mental health as measured using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline, 6 and 12 Months ]Measured using the Brief Psychiatric Rating Scale (BPRS)
- Social Functioning as measured using the Social Functioning Questionnaire (SFQ) [ Time Frame: Baseline, 6 and 12 Months ]Measured using the Social Functioning Questionnaire (SFQ)
- Self-Esteem as measured using the Rosenberg's Self Esteem Scale [ Time Frame: Baseline, 6 and 12 Months ]Measured using the Rosenberg's Self Esteem Scale
- Work Limitations as measured using the Work Limitation Questionnaire [ Time Frame: Baseline, 6 and 12 Months ]Measured using the Work Limitation Questionnaire
- Quality of life as measured using SF-12v2 [ Time Frame: Baseline, 6 and 12 Months ]Health-related quality of life as measured using SF-12v2
- Economic Costing as measured using the Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline, 6 and 12 Months ]Measured using the Client Service Receipt Inventory (CSRI)
- Re-offending rates [ Time Frame: Baseline and 18 Months ]Re-offending rates
- Number of days in open employment [ Time Frame: 12 months ]Number of days in open employment at 12 months
- Quality of life as measured using the EQ5-D [ Time Frame: Baseline, 6 and 12 months ]Health-related quality of life as measured using the EQ5-D
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442193
|Nottinghamshire NHS Foundation Trust|
|Nottingham, United Kingdom|
|Principal Investigator:||Najat R Khalifa, DM||Nottinghamshire Healthcare NHS Trust|