Clinical trial NCT02442193: Individual Placement and Support for Patients With Offending Histories
Official title: Individual Placement and Support (IPS) for Patients With Offending Histories: Feasibility of an Evidence-based Approach in Forensic Mental Health Settings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Employment, Supported
Treatment as Usual
Lead sponsor: Nottinghamshire Healthcare NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Nottingham
name: University of Southampton
name: University of Leicester
name: Institute of Mental Health Nottingham
First posted: 2015-05-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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

Primary outcomes:
measure: Open Employment: Proportion of people in open employment
timeFrame: 12 Months
Secondary outcomes:
measure: Number of hours worked
timeFrame: 12 Months
measure: Mental health as measured using the Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline, 6 and 12 Months
measure: Social Functioning as measured using the Social Functioning Questionnaire (SFQ)
timeFrame: Baseline, 6 and 12 Months
measure: Self-Esteem as measured using the Rosenberg's Self Esteem Scale
timeFrame: Baseline, 6 and 12 Months
measure: Work Limitations as measured using the Work Limitation Questionnaire
timeFrame: Baseline, 6 and 12 Months
measure: Quality of life as measured using SF-12v2
timeFrame: Baseline, 6 and 12 Months
measure: Economic Costing as measured using the Client Service Receipt Inventory (CSRI)
timeFrame: Baseline, 6 and 12 Months
measure: Re-offending rates
timeFrame: Baseline and 18 Months
measure: Number of days in open employment
timeFrame: 12 months
measure: Quality of life as measured using the EQ5-D
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottinghamshire NHS Foundation Trust
Study officials:
affiliation: Nottinghamshire Healthcare NHS Trust
name: Najat R Khalifa, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.