NCT02442193

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 15, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2017

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

May 7, 2015

Last Update Submit

February 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Open Employment: Proportion of people in open employment

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

    12 Months

Secondary Outcomes (10)

  • Number of hours worked

    12 Months

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

    Baseline, 6 and 12 Months

  • Social Functioning as measured using the Social Functioning Questionnaire (SFQ)

    Baseline, 6 and 12 Months

  • Self-Esteem as measured using the Rosenberg's Self Esteem Scale

    Baseline, 6 and 12 Months

  • Work Limitations as measured using the Work Limitation Questionnaire

    Baseline, 6 and 12 Months

  • +5 more secondary outcomes

Study Arms (2)

Individual Placement and Support

EXPERIMENTAL

Individual Placement and Support

Other: Individual Placement and Support

Treatment as Usual

NO INTERVENTION

Treatment as Usual is comprised of routine clinical care.

Interventions

Individual Placement and Support is a form of supported employment.

Individual Placement and Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottinghamshire NHS Foundation Trust

Nottingham, United Kingdom

Location

Related Publications (2)

  • 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

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Najat R Khalifa, DM

    Nottinghamshire Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 13, 2015

Study Start

September 15, 2015

Primary Completion

September 15, 2017

Study Completion

November 3, 2017

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations