Abstract
BackgroundYoung people who have social disability associated with severe and complex mental health problems are an important group in need of early intervention. Their problems often date back to childhood and become chronic at an early age. Without intervention, the long-term prognosis is often poor and the economic costs very large. There is a major gap in the provision of evidence-based interventions for this group, and therefore new approaches to detection and intervention are needed. This trial provides a definitive evaluation of a new approach to early intervention with young people with social disability and severe and complex mental health problems using social recovery therapy (SRT) over a period of 9 months to improve mental health and social recovery outcomes.MethodsThis is a pragmatic, multi-centre, single blind, superiority randomised controlled trial. It is conducted in three sites in the UK: Sussex, Manchester and East Anglia. Participants are aged 16 to 25 and have both persistent and severe social disability (defined as engaged in less than 30 hours per week of structured activity) and severe and complex mental health problems. The target sample size is 270 participants, providing 135 participants in each trial arm. Participants are randomised 1:1 using a web-based randomisation system and allocated to either SRT plus optimised treatment as usual (enhanced standard care) or enhanced standard care alone. The primary outcome is time use, namely hours spent in structured activity per week at 15 months post-randomisation. Secondary outcomes assess typical mental health problems of the group, including subthreshold psychotic symptoms, negative symptoms, depression and anxiety. Time use, secondary outcomes and health economic measures are assessed at 9, 15 and 24 months post-randomisation.DiscussionThis definitive trial will be the first to evaluate a novel psychological treatment for social disability and mental health problems in young people presenting with social disability and severe and complex non-psychotic mental health problems. The results will have important implications for policy and practice in the detection and early intervention for this group in mental health services.Trial registrationTrial Registry: International Standard Randomised Controlled Trial Number (ISRCTN) Registry.Trial Registration Number: ISRCTN47998710 (registered 29/11/2012).
Highlights
Young people who have social disability associated with severe and complex mental health problems are an important group in need of early intervention
Between 3% and 5% of adolescents present with complex mental health problems associated with social disability [2]
The present study aims to undertake a definitive randomised controlled trial (RCT) to determine the clinical and cost-effectiveness of social recovery therapy (SRT) compared to enhanced standard care (ESC) in young people who present with social disability and severe and complex non-psychotic mental health problems, and who are at risk of longterm social disability and mental illness
Summary
Trial design PRODIGY is a pragmatic, multi-centre, single blind, parallel, superiority RCT comparing the clinical and costeffectiveness of SRT delivered over a 9-month period plus optimised treatment as usual (ESC) against ESC alone. A important aspect of this is identifying specific pathways to meaningful new activities and values Where relevant, this includes referral to appropriate vocational agencies, or alternatively direct liaison with employers or education providers. ESC involves the provision of a Best Practice Manual for standard treatment from the trial team to the referrer and usual care provider (if not the referrer), which summarises good practice, including referral to mental health services and medication management where appropriate. The Best Practice Manual and the approach of the trial team has been supported by service user groups and steering groups overseeing youth mental health provision in each of the regions, and its delivery has been well received by participating services, with referrers keen to involve participants in both treatment and control arms. Other outcomes include Alcohol Use Disorders Identification Test [66], Drug Use Disorders Identification Test [67] and the Beck Hopelessness Scale [68]
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