Individual Placement and Support for Patients With Offending Histories
NCT ID: NCT02442193
Last Updated: 2018-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
18 participants
INTERVENTIONAL
2015-09-15
2017-11-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Individual Placement and Support
Individual Placement and Support
Individual Placement and Support
Individual Placement and Support is a form of supported employment.
Treatment as Usual
Treatment as Usual is comprised of routine clinical care.
No interventions assigned to this group
Interventions
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Individual Placement and Support
Individual Placement and Support is a form of supported employment.
Eligibility Criteria
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Inclusion Criteria
* Patients (females and males) on the caseload of the community forensic services
Exclusion Criteria
* Patients not eligible to work in the UK
* Patients currently in open employment
* Patients who do not wish to work
18 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
University of Southampton
OTHER
University of Leicester
OTHER
Institute of Mental Health Nottingham
OTHER
Nottinghamshire Healthcare NHS Trust
OTHER_GOV
Responsible Party
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Najat Khalifa
Associate Professor
Principal Investigators
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Najat R Khalifa, DM
Role: PRINCIPAL_INVESTIGATOR
Nottinghamshire Healthcare NHS Trust
Locations
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Nottinghamshire NHS Foundation Trust
Nottingham, , United Kingdom
Countries
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References
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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.
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.
Related Links
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Study Protocol
Other Identifiers
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PB-PG-1013-32093
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KHALIFA/020415
Identifier Type: -
Identifier Source: org_study_id
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