Individual Placement and Support (IPS) for Patients With Offending Histories: Feasibility of an Evidence-based Approach in Forensic Mental Health Settings
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Open Employment: Proportion of people in open employment
研究概览
简要总结
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.
详细描述
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:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over the age of 18 years
- •Patients (females and males) on the caseload of the community forensic services
排除标准
- •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
结局指标
主要结局
Open Employment: Proportion of people in open employment
时间窗: 12 Months
Proportion of people in open employment at 12 month follow-up
次要结局
- Number of hours worked(12 Months)
- Re-offending rates(Baseline and 18 Months)
- Number of days in open employment(12 months)
- Quality of life as measured using the EQ5-D(Baseline, 6 and 12 months)
- Self-Esteem as measured using the Rosenberg's Self Esteem Scale(Baseline, 6 and 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)
- Quality of life as measured using SF-12v2(Baseline, 6 and 12 Months)
- Work Limitations as measured using the Work Limitation Questionnaire(Baseline, 6 and 12 Months)
- Economic Costing as measured using the Client Service Receipt Inventory (CSRI)(Baseline, 6 and 12 Months)
研究者
Najat Khalifa
Associate Professor
Nottinghamshire Healthcare NHS Trust