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3. Development and evaluation of a collaborative care intervention for male prison leavers with mental health problems: the Engager research programme

Author

Byng, Richard, primary, Lennox, Charlotte, additional, Kirkpatrick, Tim, additional, Quinn, Cath, additional, Anderson, Rob, additional, Brand, Sarah Louise, additional, Callaghan, Lynne, additional, Carroll, Lauren, additional, Durcan, Graham, additional, Gill, Laura, additional, Goodier, Sara, additional, Graham, Jonathan, additional, Greer, Rebecca, additional, Haddad, Mark, additional, Harris, Tirril, additional, Henley, William, additional, Hunter, Rachael, additional, Maguire, Mike, additional, Leonard, Sarah, additional, Michie, Susan, additional, Owens, Christabel, additional, Pearson, Mark, additional, Rybczynska-Bunt, Sarah, additional, Stevenson, Caroline, additional, Stewart, Amy, additional, Stirzaker, Alex, additional, Taylor, Rod, additional, Todd, Roxanne, additional, Walter, Florian, additional, Warren, Fiona C, additional, Weston, Lauren, additional, Wright, Nat, additional, and Shaw, Jenny, additional

Published
2022
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4. Evaluation of a complex intervention for prisoners with common mental health problems, near to and after release: the Engager randomised controlled trial

Author

Byng, Richard, primary, Kirkpatrick, Tim, additional, Lennox, Charlotte, additional, Warren, Fiona C., additional, Anderson, Rob, additional, Brand, Sarah Louise, additional, Callaghan, Lynne, additional, Carroll, Lauren, additional, Durcan, Graham, additional, Gill, Laura, additional, Goodier, Sara, additional, Graham, Jonathan, additional, Greer, Rebecca, additional, Haddad, Mark, additional, Harris, Tirril, additional, Henley, William, additional, Hunter, Rachael, additional, Leonard, Sarah, additional, Maguire, Mike, additional, Michie, Susan, additional, Owens, Christabel, additional, Pearson, Mark, additional, Quinn, Cath, additional, Rybczynska-Bunt, Sarah, additional, Stevenson, Caroline, additional, Stewart, Amy, additional, Stirzaker, Alex, additional, Todd, Roxanne, additional, Walter, Florian, additional, Weston, Lauren, additional, Wright, Nat, additional, Taylor, Rod S., additional, and Shaw, Jenny, additional

Published
2022
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5. Interrogating intervention delivery and participants’ emotional states to improve engagement and implementation: A realist informed multiple case study evaluation of Engager

Author

Weston, Lauren, primary, Rybczynska-Bunt, Sarah, additional, Quinn, Cath, additional, Lennox, Charlotte, additional, Maguire, Mike, additional, Pearson, Mark, additional, Stirzaker, Alex, additional, Durcan, Graham, additional, Stevenson, Caroline, additional, Graham, Jonathan, additional, Carroll, Lauren, additional, Greer, Rebecca, additional, Haddad, Mark, additional, Hunter, Rachael, additional, Anderson, Rob, additional, Todd, Roxanne, additional, Goodier, Sara, additional, Brand, Sarah, additional, Michie, Susan, additional, Kirkpatrick, Tim, additional, Leonard, Sarah, additional, Harris, Tirril, additional, Henley, William, additional, Shaw, Jenny, additional, Owens, Christabel, additional, and Byng, Richard, additional

Published
2022
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8. Evaluation of a Complex Intervention for Prisoners with Common Mental Health Problems, Near To and After Release:The Engager Randomised Controlled Trial

Author

Byng, Richard, Kirkpatrick, Tim, Lennox, Charlotte, Walter, Florian, Anderson, Robert, Brand, Sarah Louise, Callaghan, Lynne, Carroll, Lauren, Durcan, Graham, Gill, Laura, Goodier, Sara, Green, Jonathan, Greer, Rebecca, Haddad, Mark, Harris, Tirril, Henley, William, Hunter, Rachael M, Leonard, Sarah, Maguire, Mike, Michie, Susan, Owens, Christabel, Pearson, Mark, Quinn, Cath, Rybczynska-Bunt, Sarah, Stevenson, Caroline, Stewart, Amy, Stirzaker, Alex, Todd, Roxanne, Weston, Lauren, Wright, Nat, and Taylor, Rod

Abstract

Background: Many male prisoners have significant mental health problems, including anxiety and depression. High proportions struggle with with homelessness and substance misuse. Only a minority receive specialist mental health care, including on release from prison. Few theoretically informed interventions have been developed to address these complex needs, and none formally evaluated. This study tests the hypothesis that the Engager intervention improves mental health outcomes following release. Methods: Two group parallel randomised superiority trial conducted in the North West and South West of England between in 2016-19. Men serving a prison sentence of two years or less were individually allocated 1:1 to either intervention (Engager plus usual care) or the control (usual care alone) group. Engager included psychological and practical support in prison, on release, and for three to five months in the community. Primary outcome: Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), six months after release. Primary analysis compared groups based on intention to treat (ITT). Outcomes: A total of 280 men were randomised out of the 396 who were potentially eligible and agreed to participate; 105 did not meet the mental health inclusion criteria. There was no mean difference in either the ITT complete case analysis between groups (92 in each arm) for change in the CORE-OM score (1·1, 95% confidence interval -1·1 to 3·2, p= 0·325) or secondary analyses. There were no consistent clinically significant between group differences for secondary outcomes. Full implementation and delivery were not achieved with 18% receiving no post release intervention. Interpretation: Engager is the first trial of a collaborative care intervention adapted for prison leavers. The intervention was not effective using standard outcome measures. Future research may benefit from improved delivery and more sensitive outcomes measures. Trial Registration: Engager was a two group parallel randomised superiority trial (ISRCTN11707331)Funding: Funding for the study was provided by the NIHR Programme Grants for Applied Research (grant number: RP-PG-1210-12011)Declaration of Interest: None to declare.Ethical Approval: The study was approved by the UK National Health Service, Wales ResearchEthics Committee 3 (ref: 15/WA/0314), and the National Research Committee of Her Majesty’s Prison and Probation Service.

Published
2021

9. Clarifying realist analytic processes and interdisciplinary consensus processes in complex health intervention [Engager] research: A detailed worked example of Judgemental Rationality in action:A worked example of Judgemental Rationality in action

Author

Rybczynska-Bunt, Sarah, Weston, Lauren, Byng, Richard, Stirzaker, Alex, Lennox, Charlotte, Pearson, Mark, Brand, Sarah, Maguire, Mike, Durcan, Graham, Graham, Jonathan P., Leonard, Sarah, Shaw, Jennifer, Kirkpatrick, Tim, Owens, Christabel, and Quinn, Cath

Subjects
interdisciplinarity, realist evaluation, transfactual theorising, Judgemental rationality, process evaluation
Abstract

Judgemental rationality is infrequently referenced within discussions of Realist Evaluations. Judgemental rationality refers to researchers’ capacity to assess which, potential, meanings provide the most credible explanations. In evaluation work, rationale’s for analysis are provided though rarely do we see how an evaluator made judgements between competing theories, and which theories were discarded and why. We provide a worked example of the application of judgemental rationality. The Engager intervention offered support to prison leavers with common mental health problems. The data for 24, purposively sampled, participants from the intervention arm of the trial, were integrated. Bhaskar’s (2016) DREIC, a 5-step analytical procedure, was used to transfactually theorise and interrogate the inferences made within, and across, cases. The findings demonstrated that the intervention was more effective when practitioners developed an in-depth understanding of the participant. We recommend that intervention developers look for ways to enhance therapeutic competencies and judgemental rationality in practitioner teams.

Published
2021

10. Clarifying realist analytic and interdisciplinary consensus processes in a complex health intervention: A worked example of Judgemental Rationality in action

Author

Rybczynska-Bunt, Sarah, primary, Weston, Lauren, additional, Byng, Richard, additional, Stirzaker, Alex, additional, Lennox, Charlotte, additional, Pearson, Mark, additional, Brand, Sarah, additional, Maguire, Mike, additional, Durcan, Graham, additional, Graham, Jonathan, additional, Leonard, Sarah, additional, Shaw, Jenny, additional, Kirkpatrick, Tim, additional, Owens, Christabel, additional, and Quinn, Cath, additional

Published
2021
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11. Economic evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: a cost-utility and cost-consequences analysis

Author

Hunter, Rachael Maree, primary, Anderson, Rob, additional, Kirkpatrick, Tim, additional, Lennox, Charlotte, additional, Warren, Fiona, additional, Taylor, Rod S., additional, Shaw, Jenny, additional, Haddad, Mark, additional, Stirzaker, Alex, additional, Maguire, Mike, additional, and Byng, Richard, additional

Published
2021
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12. sj-docx-1-evi-10.1177_13563890211037699 – Supplemental material for Clarifying realist analytic and interdisciplinary consensus processes in a complex health intervention: A worked example of Judgemental Rationality in action

Author

Rybczynska-Bunt, Sarah, Weston, Lauren, Byng, Richard, Stirzaker, Alex, Lennox, Charlotte, Pearson, Mark, Brand, Sarah, Maguire, Mike, Durcan, Graham, Graham, Jonathan, Leonard, Sarah, Shaw, Jenny, Kirkpatrick, Tim, Owens, Christabel, and Quinn, Cath

Subjects
160807 Sociological Methodology and Research Methods, FOS: Sociology
Abstract

Supplemental material, sj-docx-1-evi-10.1177_13563890211037699 for Clarifying realist analytic and interdisciplinary consensus processes in a complex health intervention: A worked example of Judgemental Rationality in action by Sarah Rybczynska-Bunt, Lauren Weston, Richard Byng, Alex Stirzaker, Charlotte Lennox, Mark Pearson, Sarah Brand, Mike Maguire, Graham Durcan, Jonathan Graham, Sarah Leonard, Jenny Shaw, Tim Kirkpatrick, Christabel Owens and Cath Quinn in Evaluation

Published
2021
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13. Evaluation of a Complex Intervention for Prisoners with Common Mental Health Problems, Near To and After Release: The Engager Randomised Controlled Trial

Author

Byng, Richard, primary, Kirkpatrick, Tim, additional, Lennox, Charlotte, additional, Warren, Fiona C., additional, Anderson, Robert, additional, Brand, Sarah Louise, additional, Callaghan, Lynne, additional, Carroll, Lauren, additional, Durcan, Graham, additional, Gill, Laura, additional, Goodier, Sara, additional, Graham, Jonathan, additional, Greer, Rebecca, additional, Haddad, Mark, additional, Harris, Tirril, additional, Henley, William, additional, Hunter, Rachael M., additional, Leonard, Sarah, additional, Maguire, Mike, additional, Michie, Susan, additional, Owens, Christabel, additional, Pearson, Mark, additional, Quinn, Cath, additional, Rybczynska-Bunt, Sarah, additional, Stevenson, Caroline, additional, Stewart, Amy, additional, Stirzaker, Alex, additional, Todd, Roxanne, additional, Walter, Florian, additional, Weston, Lauren, additional, Wright, Nat, additional, and taylor, rod, additional

Published
2021
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14. Supplementary_material_EVI – Supplemental material for Building programme theory to develop more adaptable and scalable complex interventions: Realist formative process evaluation prior to full trial

Author

Brand, Sarah Louise, Quinn, Cath, Pearson, Mark, Lennox, Charlotte, Christabel Owens, Kirkpatrick, Tim, Callaghan, Lynne, Stirzaker, Alex, Michie, Susan, Maguire, Mike, Shaw, Jennifer, and Byng, Richard

Subjects
160807 Sociological Methodology and Research Methods, FOS: Sociology
Abstract

Supplemental material, Supplementary_material_EVI for Building programme theory to develop more adaptable and scalable complex interventions: Realist formative process evaluation prior to full trial by Sarah Louise Brand, Cath Quinn, Mark Pearson, Charlotte Lennox, Christabel Owens, Tim Kirkpatrick, Lynne Callaghan, Alex Stirzaker, Susan Michie, Mike Maguire, Jennifer Shaw and Richard Byng in Evaluation

Published
2018
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15. Building programme theory to develop more adaptable and scalable complex interventions: Realist formative process evaluation prior to full trial

Author

Brand, Sarah Louise, primary, Quinn, Cath, additional, Pearson, Mark, additional, Lennox, Charlotte, additional, Owens, Christabel, additional, Kirkpatrick, Tim, additional, Callaghan, Lynne, additional, Stirzaker, Alex, additional, Michie, Susan, additional, Maguire, Mike, additional, Shaw, Jennifer, additional, and Byng, Richard, additional

Published
2018
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16. Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial

Author

Kirkpatrick, Tim, primary, Lennox, Charlotte, additional, Taylor, Rod, additional, Anderson, Rob, additional, Maguire, Michael, additional, Haddad, Mark, additional, Michie, Susan, additional, Owens, Christabel, additional, Durcan, Graham, additional, Stirzaker, Alex, additional, Henley, William, additional, Stevenson, Caroline, additional, Carroll, Lauren, additional, Quinn, Cath, additional, Brand, Sarah Louise, additional, Harris, Tirril, additional, Stewart, Amy, additional, Todd, Roxanne, additional, Rybczynska-Bunt, Sarah, additional, Greer, Rebecca, additional, Pearson, Mark, additional, Shaw, Jenny, additional, and Byng, Richard, additional

Published
2018
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17. Variation in referral and access to new psychological therapy services by age: an empirical quantitative study.

Author

Pettit, Sophie, Qureshi, Adam, Lee, William, Stirzaker, Alex, Gibson, Alex, Henley, William, Byng, Richard, Pettit, Sophie, Qureshi, Adam, Lee, William, Stirzaker, Alex, Gibson, Alex, Henley, William, and Byng, Richard

Abstract

Background: Older people with common mental health problems (CMHPs) are known to have reduced rates of referral to psychological therapy. Aim: We aimed to assess referral rates to the Improving Access to Psychological Therapies (IAPT) service, contact with a therapist and clinical outcome by age. Design and Setting: Empirical research using patient episodes of care from South West IAPT. Method: By analysing 82,513 episodes of care (2010-2011), referral rates and clinical improvement were compared to both total population and estimated prevalence in each age group using IAPT data. Probable recovery of those completing treatment were calculated for each group. Results: Estimated prevalence of CMHPs peaks in 45–49 year olds (20.59% of population). The proportions of patients identified with CMHPs being referred peaks at 20-24 years (22.95%) and reduces with increase in age thereafter to 6.00% for 70-74 year olds. Once referred, the proportion of those attending first treatment increases with age between 18 years (57.64%) and 64 years (76.97%). In addition, the percentage of those having a clinical improvement gradually increases from the age 20 years (12.94%) to 69 years (20.74%). Conclusion: Younger adults are more readily referred to IAPT services. However, as a proportion of those referred, probabilities of attending once, attending more than once, and clinical improvement, increase with age. It is uncertain whether optimum levels of referral have been reached for young adults. It is important to establish whether changes to service configuration, treatment options, and GP behaviour can increase referrals for middle-aged and older adults.

Published
2017

19. Building programme theory to develop more adaptable and scalable complex interventions: Realist formative process evaluation prior to full trial.

Author

Brand, Sarah Louise, Quinn, Cath, Pearson, Mark, Lennox, Charlotte, Owens, Christabel, Kirkpatrick, Tim, Callaghan, Lynne, Stirzaker, Alex, Michie, Susan, Maguire, Mike, Shaw, Jennifer, and Byng, Richard

Subjects
FORMATIVE evaluation, THEORY, MEDICAL research
Abstract

Medical Research Council guidelines recognise the need to optimise complex interventions prior to full trial through greater understanding of underlying theory and formative process evaluation, yet there are few examples. A realist approach to formative process evaluation makes a unique contribution through a focus on theory formalisation and abstraction. The success of an intervention is dependent on the extent to which it gels or jars with existing provision and can be successfully transferred to new contexts. Interventions with underlying programme theory about how they work, for whom, and under which circumstances will be better able to adapt to work with (rather than against) different services, individuals, and settings. In this methodological article, we describe and illustrate how a realist approach to formative process evaluation develops contextualised intervention theory that can underpin more adaptable and scalable interventions. We discuss challenges and benefits of this approach. [ABSTRACT FROM AUTHOR]

Published
2019
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22. Book Cover

Author

Rapley, Mark, primary, Robson, June, additional, Guha, Martin, additional, Lobley, John, additional, Turpin, Graham, additional, Stirzaker, Alex, additional, Pillay, Herby M., additional, Cormack, Maggie, additional, and Hayward, Peter, additional

Published
1993
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23. Book Cover

Author

Newnes, Craig, primary, Stirzaker, Alex, additional, Mollon, Phil, additional, Thomas, Simon, additional, Milne, Derek, additional, Tyler, Peter, additional, McConachie, Helen, additional, Wooding, Graham, additional, Edeleanu, Andrea, additional, and Gelsthorpe, Simon, additional

Published
1993
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24. CORRESPONDENCECORRESPONDENCE: SAD?CORRESPONDENCE: ECT, the DCP and MECORRESPONDENCE: Threats to the professionCORRESPONDENCE: Concessionary membership ratesCORRESPONDENCE: Affiliates Group

Author

Boyle, Mary, primary, Eaton, June, primary, Nunn, Kenneth, primary, Crawford-Wright, Anne, primary, Dick, Nina, primary, Fitzgerald, John, additional, Newell, Adrian, additional, Newnes, Craig, additional, Stirzaker, Alex, additional, and Sutherland, Alistair, additional

Published
1992
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26. 'The taboo which silences': Is erotic transference a help or a hindrance in the counselling relationship?

Author

Stirzaker, Alex

Abstract

This paper explores why open dialogue on the subject of erotic transference and countertransference is so difficult and attempts to offer an understanding of these phenomena which might enable counsellors to work more confidently with it. It also briefly examines the author's own research on therapists' thoughts and experiences of erotic transference, seeking to differentiate between inappropriate sexual contact between clients and therapists and the experience of erotic transference in the context of therapy as a reworking of the Oedipal relationship. Case examples illustrating the experience of countertransference within the therapeutic situation and how its presence can act as a help or a hindrance are offered. The paper concludes by examining the need to reflect on the erotic transference in therapeutic work and proposes its usefulness as a therapeutic tool. Suggestions about how the erotic transference can be managed to therapeutic effect are also explored.

Published
2001
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28. Characteristics of positive feedback provided by UK health service users: content analysis of examples from two databases.

Author

Lloyd R, Slade M, Byng R, Russell A, Ng F, Stirzaker A, and Rennick-Egglestone S

Subjects
Humans, United Kingdom, State Medicine, Patient Satisfaction, Databases, Factual, Feedback
Abstract

Background: Most feedback received by health services is positive. Our systematic scoping review mapped all available empirical evidence for how positive patient feedback creates healthcare change. Most included papers did not provide specific details on positive feedback characteristics., Objectives: Describe positive feedback characteristics by (1) developing heuristics for identifying positive feedback; (2) sharing annotated feedback examples; (3) describing their positive content., Methods: 200 items were selected from two contrasting databases: (1) https://careopinion.org.uk/; (2) National Health Service (NHS) Friends and Family Test data collected by an NHS trust. Preliminary heuristics and positive feedback categories were developed from a small convenience sample, and iteratively refined., Results: Categories were identified: positive-only; mixed; narrative; factual; grateful. We propose a typology describing tone (positive-only, mixed), form (factual, narrative) and intent (grateful). Separating positive and negative elements in mixed feedback was sometimes impossible due to ambiguity. Narrative feedback often described the cumulative impact of interactions with healthcare providers, healthcare professionals, influential individuals and community organisations. Grateful feedback was targeted at individual staff or entire units, but the target was sometimes ambiguous., Conclusion: People commissioning feedback collection systems should consider mechanisms to maximise utility by limiting ambiguity. Since being enabled to provide narrative feedback can allow contributors to make contextualised statements about what worked for them and why, then there may be trade-offs to negotiate between limiting ambiguity, and encouraging rich narratives. Groups tasked with using feedback should plan the human resources needed for careful inspection, and consider providing narrative analysis training., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2024
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29. Evaluation of a complex intervention for prisoners with common mental health problems, near to and after release: the Engager randomised controlled trial.

Author

Byng R, Kirkpatrick T, Lennox C, Warren FC, Anderson R, Brand SL, Callaghan L, Carroll L, Durcan G, Gill L, Goodier S, Graham J, Greer R, Haddad M, Harris T, Henley W, Hunter R, Leonard S, Maguire M, Michie S, Owens C, Pearson M, Quinn C, Rybczynska-Bunt S, Stevenson C, Stewart A, Stirzaker A, Todd R, Walter F, Weston L, Wright N, Taylor RS, and Shaw J

Subjects
Male, Humans, Cost-Benefit Analysis, Anxiety, England, Mental Health, Prisoners
Abstract

Background: Many male prisoners have significant mental health problems, including anxiety and depression. High proportions struggle with homelessness and substance misuse., Aims: This study aims to evaluate whether the Engager intervention improves mental health outcomes following release., Method: The design is a parallel randomised superiority trial that was conducted in the North West and South West of England (ISRCTN11707331). Men serving a prison sentence of 2 years or less were individually allocated 1:1 to either the intervention (Engager plus usual care) or usual care alone. Engager included psychological and practical support in prison, on release and for 3-5 months in the community. The primary outcome was the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), 6 months after release. Primary analysis compared groups based on intention-to-treat (ITT)., Results: In total, 280 men were randomised out of the 396 who were potentially eligible and agreed to participate; 105 did not meet the mental health inclusion criteria. There was no mean difference in the ITT complete case analysis between groups (92 in each arm) for change in the CORE-OM score (1.1, 95% CI -1.1 to 3.2, P = 0.325) or secondary analyses. There were no consistent clinically significant between-group differences for secondary outcomes. Full delivery was not achieved, with 77% (108/140) receiving community-based contact., Conclusions: Engager is the first trial of a collaborative care intervention adapted for prison leavers. The intervention was not shown to be effective using standard outcome measures. Further testing of different support strategies for prison with mental health problems is needed.

Published
2023
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30. Development and evaluation of a collaborative care intervention for male prison leavers with mental health problems: the Engager research programme

Author

Byng R, Lennox C, Kirkpatrick T, Quinn C, Anderson R, Brand SL, Callaghan L, Carroll L, Durcan G, Gill L, Goodier S, Graham J, Greer R, Haddad M, Harris T, Henley W, Hunter R, Maguire M, Leonard S, Michie S, Owens C, Pearson M, Rybczynska-Bunt S, Stevenson C, Stewart A, Stirzaker A, Taylor R, Todd R, Walter F, Warren FC, Weston L, Wright N, and Shaw J

Abstract

Background: Many male prison leavers have significant mental health problems. Prison leavers often have a history of trauma, ongoing substance misuse and housing insecurity. Only a minority of prison leavers receive mental health care on release from prison., Objectives: The aim of the Engager research programme was to develop and evaluate a theory- and evidence-informed complex intervention designed to support individuals with common mental health problems (e.g. anxiety, depression) and other complex needs, including mental health comorbidity, before and after release from prison., Methods: In phase 1, the intervention was developed through a set of realist-informed substudies, including a realist review of psychosocial care for individuals with complex needs, case studies within services demonstrating promising intervention features, focus groups with individuals from under-represented groups, a rapid realist review of the intervention implementation literature and a formative process evaluation of the prototype intervention. In a parallel randomised trial, methodological development included selecting outcome measures through reviewing literature, piloting measures and a consensus process, developing ways to quantify intervention receipt, piloting trial procedures and modelling economic outcomes. In phase 2, we conducted an individually randomised superiority trial of the Engager intervention, cost-effectiveness and cost–consequence analyses and an in-depth mixed-methods process evaluation. Patient and public involvement influenced the programme throughout, primarily through a Peer Researcher Group., Results: In phase 1, the Engager intervention included multiple components. A practitioner offered participants practical support, emotional help (including mentalisation-based approaches) and liaison with other services in prison on the day of the participant’s release and for 3–5 months post release. An intervention delivery platform (i.e. training, manual, supervision) supported implementation. Outcome measures were selected through testing and stakeholder consensus to represent a broad range of domains, with a general mental health outcome as the primary measure for the trial. Procedures for recruitment and follow-up were tested and included flexible approaches to engagement and retention. In phase 2, the trial was conducted in three prison settings, with 280 participants randomised in a 1 : 1 ratio to receive either Engager plus usual care ( n  = 140) or usual care only ( n  = 140). We achieved a follow-up rate of 65% at 6 months post release from prison. We found no difference between the two groups for the Clinical Outcomes in Routine Evaluation – Outcome Measure at 6 months. No differences in secondary measures and sensitivity analyses were found beyond those expected by chance. The cost-effectiveness analysis showed that Engager cost significantly more at £2133 (95% of iterations between £997 and £3374) with no difference in quality-adjusted life-years (–0.017, 95% of iterations between –0.042 and 0.007). The mixed-methods process evaluation demonstrated implementation barriers. These barriers included problems with retention of the intervention team, and the adverse health and criminal justice system context. Seventy-seven per cent (108/140) of individuals had at least one community contact. Significant proportions of participants engaging received day release work and practical support. In contrast, there was evidence that the psychological components, mentalisation and developing a shared understanding were used less consistently. When engagement was positive, these components were associated with positive achievement of goals for individuals. We were also able to identify how to improve the intervention programme theory, including how to support individuals who were unrealistic in their perception of their ability to cope with challenges post release., Strengths and Limitations: Our development work provides a worked example of the development of a complex intervention, particularly given little prior evidence or theory specific to male offenders to build on. Our trial methodological development enabled the completion of, to the best of our knowledge, the first fully powered trial of a mental health intervention for prison leavers with common mental health problems. There were potential weaknesses in the trial methodology in terms of follow-up rates and outcome measures, with the latter potentially being insufficiently sensitive to important but highly individual changes in participants who responded to the intervention., Conclusions: Delivering a randomised controlled trial for prison leavers with acceptable levels of follow-up is possible, despite adverse conditions. Full intervention implementation was challenging, but this is to be expected. Some individuals did respond well to the intervention when both practical and psychological support were flexibly deployed as intended, with evidence that most components were experienced as helpful for some individuals. It is recommended that several key components be developed further and tested, along with improved training and supervision, to support delivery of the Engager intervention within existing teams working with prison leavers., Trial Registration: This trial is registered as ISRCTN11707331., Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research ; Vol. 10, No. 8. See the NIHR Journals Library website for further project information., (Copyright © 2022 Byng et al. This work was produced by Byng et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.)

Published
2022
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