Employment, SupportedIPSOHNCT02442193
Individual Placement and Support for Patients With Offending Histories
A study testing Individual Placement and Support in people with Employment, Supported and Treatment as Usual, run by Nottinghamshire Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Employment, Supported, Treatment as Usual
- What is being tested?
- Individual Placement and Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2015to 3 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over the age of 18 years
- Patients (females and males) on the caseload of the community forensic services
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individual Placement and Support (IPS) for Patients With Offending Histories: Feasibility of an Evidence-based Approach in Forensic Mental Health Settings
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:
- 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.
- Feasibility Cluster Randomized Controlled Trial (RCT): The specific objectives of this strand are to estimate the parameters required to design a full RCT including:
- Means and standard deviations of the key outcome measures in order to benchmark potential effect sizes and enable sample size calculations.
- The feasibility of randomization, recruitment and retention rates to the IPS and controls;
- The suitability of the key outcome measures with respect to: reliability, acceptability, and distribution of the scores.
- Process Evaluation: This will be carried out in parallel with the other two strands to meet other specific objectives by using the following methods:
- 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.
- 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.
- 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
- Employment, Supported, Treatment as Usual
- Being tested
- Individual Placement and Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Placement and SupportOther
Individual Placement and Support is a form of supported employment.
| Study group | Role | What they receive |
|---|---|---|
| Individual Placement and Support | Experimental | Individual Placement and Support Receives: Other: Individual Placement and Support |
| Treatment as Usual | No intervention | Treatment as Usual is comprised of routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Open Employment: Proportion of people in open employment
Proportion of people in open employment at 12 month follow-up
Measured: 12 Months
Secondary outcomes (10)
Number of hours worked
Number of hours worked at 12 month follow-up
Measured: 12 Months
Mental health as measured using the Brief Psychiatric Rating Scale (BPRS)
Measured using the Brief Psychiatric Rating Scale (BPRS)
Measured: Baseline, 6 and 12 Months
Social Functioning as measured using the Social Functioning Questionnaire (SFQ)
Measured using the Social Functioning Questionnaire (SFQ)
Measured: Baseline, 6 and 12 Months
Self-Esteem as measured using the Rosenberg's Self Esteem Scale
Measured using the Rosenberg's Self Esteem Scale
Measured: Baseline, 6 and 12 Months
Work Limitations as measured using the Work Limitation Questionnaire
Measured using the Work Limitation Questionnaire
Measured: Baseline, 6 and 12 Months
Quality of life as measured using SF-12v2
Health-related quality of life as measured using SF-12v2
Measured: Baseline, 6 and 12 Months
Economic Costing as measured using the Client Service Receipt Inventory (CSRI)
Measured using the Client Service Receipt Inventory (CSRI)
Measured: Baseline, 6 and 12 Months
Re-offending rates
Re-offending rates
Measured: Baseline and 18 Months
Number of days in open employment
Number of days in open employment at 12 months
Measured: 12 months
Quality of life as measured using the EQ5-D
Health-related quality of life as measured using the EQ5-D
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study start15 Sep 2015
- Primary completion15 Sep 2017
- Study completion3 Nov 2017
Why it stopped: Terminated by the funder due to low recruitment rates.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Employment, SupportedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottinghamshire Healthcare NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Nottingham, University of Southampton, University of Leicester, Institute of Mental Health Nottingham
- Responsible party
- Principal investigator, Najat Khalifa, Nottinghamshire Healthcare NHS Trust
- Investigators
- Najat R Khalifa, DM, Principal investigator, Nottinghamshire Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442193
- Sponsor's protocol ID
- KHALIFA/020415
- Other IDs
- PB-PG-1013-32093
- Acronym
- IPSOH
- Status last verified
- Feb 2018
- First submitted
- 7 May 2015
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 27449894Khalifa 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Placement and Support (IPS) for Patients With Offending Histories: Feasibility of an Evidence-based Approach in Forensic Mental Health Settings
- ClinicalTrials.gov ID
- NCT02442193
- Acronym / sponsor ID
- IPSOH / KHALIFA/020415
- Conditions
- Employment, Supported, Treatment as Usual
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by the funder due to low recruitment rates.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nottinghamshire Healthcare NHS TrustOther government
- Collaborators
- University of Nottingham, University of Southampton, University of Leicester, Institute of Mental Health Nottingham
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 3 Nov 2017 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Feasibility Cluster Randomized Controlled Trial (RCT): The specific objectives of this strand are to estimate the parameters required to design a full RCT including:
- Means and standard deviations of the key outcome measures in order to benchmark potential effect sizes and enable sample size calculations.
- The feasibility of randomization, recruitment and retention rates to the IPS and controls;
- The suitability of the key outcome measures with respect to: reliability, acceptability, and distribution of the scores.
- Process Evaluation: This will be carried out in parallel with the other two strands to meet other specific objectives by using the following methods:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Placement and Support | Experimental | Other: Individual Placement and SupportIndividual Placement and Support |
| Treatment as Usual | No intervention | –Treatment as Usual is comprised of routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults over the age of 18 years
- Patients (females and males) on the caseload of the community forensic services
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Placement and SupportIndividual Placement and Support is a form of supported employment. | Other | Individual Placement and Support |
Primary outcome
Open Employment: Proportion of people in open employment
Time frame: 12 Months
Proportion of people in open employment at 12 month follow-up
10 secondary outcomes
Number of hours worked
Time frame: 12 Months
Mental health as measured using the Brief Psychiatric Rating Scale (BPRS)
Time frame: Baseline, 6 and 12 Months
Social Functioning as measured using the Social Functioning Questionnaire (SFQ)
Time frame: Baseline, 6 and 12 Months
Self-Esteem as measured using the Rosenberg's Self Esteem Scale
Time frame: Baseline, 6 and 12 Months
Work Limitations as measured using the Work Limitation Questionnaire
Time frame: Baseline, 6 and 12 Months
Quality of life as measured using SF-12v2
Time frame: Baseline, 6 and 12 Months
Economic Costing as measured using the Client Service Receipt Inventory (CSRI)
Time frame: Baseline, 6 and 12 Months
Re-offending rates
Time frame: Baseline and 18 Months
Number of days in open employment
Time frame: 12 months
Quality of life as measured using the EQ5-D
Time frame: Baseline, 6 and 12 months
Results and safety
The study was stopped early (reason given: Terminated by the funder due to low recruitment rates.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Results publication: PubMed 27449894Khalifa 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.
- Derived from this study: PubMed 31998164Khalifa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Najat R Khalifa, DM principal investigator
Nottinghamshire Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Placement and Support in people with Employment, Supported and Treatment as Usual, run by Nottinghamshire Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated by the funder due to low recruitment rates.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Open Employment: Proportion of people in open employment (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02442193, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.