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TerminatedNCT02442193IPSOHUpdated Feb 12, 2018

Individual Placement and Support for Patients With Offending Histories

An interventional study of Individual Placement and Support in Employment, Supported and Treatment as Usual, sponsored by Nottinghamshire Healthcare NHS Trust. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-12.

Sponsored by Nottinghamshire Healthcare NHS Trust · Not applicable, Interventional, and Health services research

Why this study was terminated
Terminated by the funder due to low recruitment rates.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Employment, Supported
  • Treatment as Usual
03

In context

Lead sponsor

Nottinghamshire Healthcare NHS Trust is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults over the age of 18 years
  • Patients (females and males) on the caseload of the community forensic services

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Individual Placement and Support

    Individual Placement and Support

    Other: Individual Placement and Support

  • No intervention
    Treatment as Usual

    Treatment as Usual is comprised of routine clinical care.

Interventions

  • OtherIndividual Placement and Support

    Individual Placement and Support is a form of supported employment.

06

What researchers measure

Primary outcomes

  1. Open Employment: Proportion of people in open employment

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

    Time frame: 12 Months

Secondary outcomes

  1. Number of hours worked

    Number of hours worked at 12 month follow-up

    Time frame: 12 Months

  2. Mental health as measured using the Brief Psychiatric Rating Scale (BPRS)

    Measured using the Brief Psychiatric Rating Scale (BPRS)

    Time frame: Baseline, 6 and 12 Months

  3. Social Functioning as measured using the Social Functioning Questionnaire (SFQ)

    Measured using the Social Functioning Questionnaire (SFQ)

    Time frame: Baseline, 6 and 12 Months

  4. Self-Esteem as measured using the Rosenberg's Self Esteem Scale

    Measured using the Rosenberg's Self Esteem Scale

    Time frame: Baseline, 6 and 12 Months

  5. Work Limitations as measured using the Work Limitation Questionnaire

    Measured using the Work Limitation Questionnaire

    Time frame: Baseline, 6 and 12 Months

  6. Quality of life as measured using SF-12v2

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

    Time frame: Baseline, 6 and 12 Months

  7. Economic Costing as measured using the Client Service Receipt Inventory (CSRI)

    Measured using the Client Service Receipt Inventory (CSRI)

    Time frame: Baseline, 6 and 12 Months

  8. Re-offending rates

    Re-offending rates

    Time frame: Baseline and 18 Months

  9. Number of days in open employment

    Number of days in open employment at 12 months

    Time frame: 12 months

  10. Quality of life as measured using the EQ5-D

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

    Time frame: Baseline, 6 and 12 months

07

Study locations

1 site
  • Nottinghamshire NHS Foundation Trust
    Nottingham, United Kingdom
08

References and documents

Publications

  • Khalifa N, Talbot E, Schneider J, Walker DM, Bates P, Bird Y, Davies D, Brookes C, Hall J, Vollm B. Individual placement and support (IPS) for patients with offending histories: the IPSOH feasibility cluster randomised trial protocol. BMJ Open. 2016 Jul 22;6(7):e012710. doi: 10.1136/bmjopen-2016-012710. PubMed 27449894 ↗
  • Khalifa N, Talbot E, Barber S, Schneider J, Bird Y, Attfield J, Bates P, Walker DM, Vollm B. A Feasibility Cluster Randomized Controlled Trial of Individual Placement and Support (IPS) for Patients With Offending Histories. Front Psychiatry. 2020 Jan 13;10:952. doi: 10.3389/fpsyt.2019.00952. eCollection 2019. PubMed 31998164 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02442193
Lead sponsor
Nottinghamshire Healthcare NHS Trust
Collaborators
University of Nottingham, University of Southampton, University of Leicester, Institute of Mental Health Nottingham
Responsible party
Najat Khalifa (Associate Professor, Nottinghamshire Healthcare NHS Trust) — Principal investigator
First posted
May 13, 2015
Start date
Sep 15, 2015
Primary completion
Sep 15, 2017
Completion
Nov 3, 2017
Last update
Feb 12, 2018

Study contacts

Najat R Khalifa, DM
principal investigator · Nottinghamshire Healthcare NHS Trust

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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