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Individual Placement and Support for Patients With Offending Histories (IPSOH)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02442193
First Posted: May 13, 2015
Last Update Posted: September 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Nottingham
University of Southampton
University of Leicester
Institute of Mental Health Nottingham
Information provided by (Responsible Party):
Najat Khalifa, Nottinghamshire Healthcare NHS Trust
  Purpose
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.

Condition Intervention
Employment, Supported Treatment as Usual Other: Individual Placement and Support

Study Type: Interventional
Study Design: Allocation: Randomized
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

Further study details as provided by Najat Khalifa, Nottinghamshire Healthcare NHS Trust:

Primary Outcome Measures:
  • Open Employment: Proportion of people in open employment [ Time Frame: 12 Months ]
    Proportion of people in open employment at 12 month follow-up


Secondary Outcome Measures:
  • 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


Enrollment: 18
Study Start Date: March 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442193


Locations
United Kingdom
Nottinghamshire NHS Foundation Trust
Nottingham, United Kingdom
Sponsors and Collaborators
Nottinghamshire Healthcare NHS Trust
University of Nottingham
University of Southampton
University of Leicester
Institute of Mental Health Nottingham
Investigators
Principal Investigator: Najat R Khalifa, DM Nottinghamshire Healthcare NHS Trust
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Najat Khalifa, Associate Professor, Nottinghamshire Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT02442193     History of Changes
Other Study ID Numbers: KHALIFA/020415
PB-PG-1013-32093 ( Other Grant/Funding Number: NIHR - Research for Patient Benefit (RfPB) )
First Submitted: May 7, 2015
First Posted: May 13, 2015
Last Update Posted: September 22, 2016
Last Verified: September 2016