Individual Placement and Support for Patients With Offending Histories

NCT ID: NCT02442193

Last Updated: 2018-02-12

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-15

Study Completion Date

2017-11-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Employment, Supported Treatment as Usual

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Individual Placement and Support

Individual Placement and Support

Group Type EXPERIMENTAL

Individual Placement and Support

Intervention Type OTHER

Individual Placement and Support is a form of supported employment.

Treatment as Usual

Treatment as Usual is comprised of routine clinical care.

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nottingham

OTHER

Sponsor Role collaborator

University of Southampton

OTHER

Sponsor Role collaborator

University of Leicester

OTHER

Sponsor Role collaborator

Institute of Mental Health Nottingham

OTHER

Sponsor Role collaborator

Nottinghamshire Healthcare NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Najat Khalifa

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United Kingdom

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.

Reference Type RESULT
PMID: 27449894 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31998164 (View on PubMed)

Related Links

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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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