This external pilot trial is reported in accord with the CONSORT 2010 statement: extension to randomised pilot and feasibility trials (Additional file 1).
Design
This pilot study undertook a parallel two-group RCT design with participants allocated to either the ENGAGER intervention or treatment as usual (TAU) with a parallel mixed methods process evaluation.
Setting
The study took place in two prisons housing adult male prisoners only in two regions (North West and South West) of England.
Participants
Prison records were searched to identify an initial list of potential participants. Those eligible had to be male, currently serving a prison sentence of up to and including 2 years, within four to 16 weeks of their release date, and planning to resettle within the geographical area of the study. Participants were ineligible if they were identified by reviewing clinical records and in discussion with the prison in-reach team as having a severe and enduring mental illness, and/or were on the caseload of the prison mental health in-reach team, and/or were on the caseload of the Offender Personality Disorder Pathway programme. Those who presented a serious risk of harm to the researchers or intervention practitioners, and those unable to provide informed consent, were also excluded.
The rational for only including males was both pragmatic and clinical. The number of females in prison is much smaller, and the prisons are geographically remote, therefore impacting the feasibility of a trial.
At the North West site, eligible participants were approached by a Clinical Studies Officer from the Clinical Research Network, and at the South West site, they were approached by one of the researchers. In the South West, the research team had gained approval to approach participants directly, arguing it is inappropriate to use prison staff, including prison healthcare staff, to make the first approach because of the potentially coercive (or perceived coercive) nature of the relationship in the prison environment.
Potential participants were approached verbally and then, if willing to consider participation, provided with written information about the study and an opportunity for further discussion. Having had the opportunity to discuss their involvement in the study and ask questions, potential participants were asked to sign the consent form if they were willing to take part.
Screening for recruitment into the trial
The screening interview was delivered in a narrative conversational format to support rapport building. It incorporated the following standardised screening measures which were read aloud to all participants in order to avoid any potential embarrassment regarding reading difficulties:
Patient health questionnaire (PHQ-9) [26]
The PHQ-9 is a nine-item scale for depressive disorder. It asks about feelings of anhedonia, low mood, sleep disturbances, poor appetite, low self-esteem, psychomotor retardation and suicidal ideation in the last 2 weeks. Participants were screened in if they reached a score of 10 or more.
Generalised Anxiety Disorder (GAD-7) [27]
The GAD-7 is a seven-item screening tool and severity measure of generalised anxiety disorder; it covers feelings of fear, worry, restlessness and irritability in the last 2 weeks. Participants were screened in if they reached a score of 10 or more.
Primary care post-traumatic stress screening scale (PTSD) [28]
The PTSD screens whether a person is presenting with PTSD symptoms as a result of a traumatic experience. The scale is based on four main symptoms of PTSD of which three or more had to be present to screen in.
Past/future common mental health problem identification
This screen was developed to capture individuals who may appear well in prison but have struggled with common mental health issues before prison and/or are likely to again after release [29]. It reports whether a person has experienced a common mental health problem including depression, anxiety and post-traumatic stress during the past 2 years which prevented them from functioning normally in everyday tasks, or if they thought this was likely to be a problem for them following release. This screen was adapted further during the pilot to be more stringent as it became evident that many people reported experiencing symptoms in the past only. Therefore, as the pilot progressed, participants were screened in on this only if they had experienced problems compatible with a common mental health problem during the past 2 years, which prevented them from functioning normally in everyday tasks and if they thought this was going to be a problem for them following release.
Participants had to screen in on at least one of the four instruments to be included in the study. Participants who screened in were given an additional information sheet, which explained the RCT. The researcher ensured that the potential participant fully understood the randomisation process, and reiterated that participation was voluntary, that they could withdraw at any time and the arrangements to ensure confidently and data protection. Based on our group work with peer researchers, they recommended that we explain the randomisation process to participants as being undertaken by a computer programme, rather than use comparisons with ‘flipping a coin’ in which human involvement suggests the potential for tampering. Having had the opportunity to discuss their involvement in the study, participants were asked to sign a second consent form if they were willing to take part.
The screening interview lasted 15–20 min, and at the end, people were informed if they had screened in or not. People screening in continued straight into the baseline interview and for those screening out this was the end of their participation in the study.
Baseline interview
The baseline interview lasted about 40 min and consisted of a range of different questionnaires and semi-structured interviews administered in order to test them for acceptability for inclusion in the full trial. The testing of these measures and decisions for inclusion in the trial is not reported in this study, but will be reported elsewhere. The baseline interview was administered by the same researcher and delivered in a conversational style. Demographic information was also collected and included information from the following domains: age, ethnicity, education, employment, housing and benefits. Current offence, sentence length and offence history were also collected.
Randomisation process
Participants identified with either current common mental health problems or probable common mental health problems upon release were randomised at a ratio of 2:1 allocation to either ENGAGER plus standard care (intervention group) or standard care alone (TAU group). To ensure concealment, randomisation was carried out by means of a web-based system developed and maintained by Peninsula Clinical Trials Unit. Communication of randomisation went to the lead researcher at each site, by automatic email. The researcher who performed the screening and baseline interview was blind to the participant’s group allocation; a second researcher visited the participant in prison to deliver a letter informing him to which group he been randomised.
Intervention
The ENGAGER intervention sets up a pathway of care up to 12 weeks prior to their release and for 3 to 5 months in the community. The intervention aims to overcome a set of challenges that have been identified as being problematic in this group including:
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Barriers associated with the transition when leaving prison and re-entering the community
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The provision of services designed to meet a single diagnostic need (e.g. depression) or social problem (e.g. homelessness) rather than the reality of people with multiple and complex needs
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Participants’ reluctance to trust services (or to see themselves as having mental health problems)
During the pilot trial, ENGAGER practitioners and supervisors met these challenges by:
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Working on individuals’ strengths to develop a shared understanding and shared plan addressing their complex needs
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Adopting a pragmatic therapeutic approach, incorporating a mentalisation-based approach alongside existing skills
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Release day working, such that each person is met at the gate and taken to their service appointments, accommodation etc. on that day
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Flexible one-to-one working including use of text messaging, practical support, crisis support and planned therapeutic work
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Using the full range of resource components—individual strengths, family and community resources, practitioner skills and additional resources/agencies in prison and the community to meet individualised goals
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Actively liaising with other services such as substance misuse teams, general practitioners and services relating to housing, employment and benefits
The Engager supervisor and practitioner meet jointly with the individual on at least two occasions in prison and once in the community to engage with individuals and to develop and review the shared understanding. Engager practitioners meet with individuals at least weekly in prison and the community after release for 8–16 weeks, according to their needs. Practitioners actively review progress, assertively follow up and liaise with others involved in the individual’s care and resettlement including families, peer mentors and other agencies and organisations identified in the development of the shared plan. Practitioners plan, work towards and deliver a positive ending. In contrast, treatment as usual consists of general practice contact for some and rarely psychological therapy. Those with opiate addiction are often seen frequently by substance misuse services.
Treatment as usual group
Individuals in the TAU group were able to access primary care, mental health and substance misuse services in the standard way while in prison. They also received support from criminal justice and any other third sector organisations in the standard way in the community.
Follow-up
After the baseline assessment meeting, the same researcher had contact with the participant on at least three further occasions. Throughout this process, attempts were made to maintain blinding to trial arm allocation, and a log was made of occasions when the researcher became aware of it. About a week before the participant’s release, a meeting was held; the main objective of which was to strengthen the researcher-participant relationship and thereby enhance follow-up rates. During this meeting, the researcher confirmed contact information that had been provided during the baseline interview and made any amendments, e.g. where phone number, addresses and contact with services had changed.
Participants were then followed up at 1 and 3 months post release by the same researcher. At approximately 1 month post release, the researcher contacted and spoke to the participant either via a phone call or (preferably) face-to-face. The main objective was again to sustain engagement and plan further contact. At this meeting the researcher discussed the 3-month follow-up in detail and agreed the best way to contact the participant for that appointment. The researcher also obtained any new mobile phone numbers if contact had been made without an up to date mobile contact, or any new addresses or services the person may now be in contact with.
The 3-month follow-up took place between 8 and 15 weeks post release, although researchers endeavoured to complete data collection as close to the 3-month point as possible. Researchers normally contacted the participants by phone or via a service they were in contact with, e.g. probation and arranged to meet them at a convenient location in the community. Where possible, interviews were conducted in the premises of services with which the participant was engaging in order to make this as convenient as possible. Where this was not possible, researchers arranged to conduct the interviews in a suitable location in the community and adhered to the Lone Working policy, being accompanied by a ‘buddy’ as an additional safeguard, if required.
As with the baseline data collection, the researcher continued to deliver the follow-up data collection interview using narrative conversational format. The same assessments at baseline were repeated at this follow-up. However, not all participants completed the same outcome measures due to testing a range of outcomes for acceptability for inclusion in the full trial. The results of the testing of these outcome measures and decisions for inclusion in the full trial will be reported elsewhere and no outcome data is reported in this study.
All researchers received training in Good Clinical Practice and in the requirements of the study protocol. Joint training for researchers at both sites was undertaken prior to commencing recruitment to the trial to ensure a consistency of approach, from consent to data collection. In addition, weekly team meetings via video conference allowed both research sites to ensure a similar quality.
Statistical analysis
Given the primary feasibility and acceptability objectives of this pilot trial, no within- or between-group inferential comparisons of outcomes were performed. Estimates of recruitment and retention rates and 95% confidence intervals (CIs) are reported. Descriptive analyses included summaries (percentages or means and 95% CIs) for participant demographics and baseline characteristics and each outcome baseline and each follow-up.