Title: The Early Youth Engagement in first episode psychosis (EYE-2) study: pragmatic cluster randomised controlled trial of implementation, effectiveness & cost effectiveness of a team-based motivational engagement intervention to improve engagement
Funder: Department of Health and Social Care

Abstract: Background: Early Intervention in Psychosis (EIP) services improve health outcomes for young people with severe mental illness in the medium-long term, but 25% of young people disengage in the first 12 months at significant cost to their mental health, their families, society & the NHS. Our own feasibility-pilot work clarified the issues that affect engagement. This study will now refine and test the team-based motivational Early Youth Engagement (EYE) intervention to improve engagement and outcomes for young people. A process evaluation will explore implementation across setting. Objectives: to refine a toolkit, resources and training for the EYE intervention, to evaluate its effectiveness, implementation, and cost-effectiveness and to disseminate widely. Study design: A cluster randomised controlled trial with economic evaluation will compare the EYE intervention + standardised EIP service to standardised EIP service alone, with randomisation at service level. A qualitative study with ethnic minority service users will ensure acceptability specifically for the diverse EIP population. An implementation study, drawing on normalisation process theory (NPT), will shape the implementation toolkit and evaluate the delivery of the intervention qualitatively and quantitatively across context. Setting: 22 EIP services in Manchester, London Norfolk, Cambridge & South of England. Sussex services will be involved in the implementation study. Populations: 880 young people (14-35 years) with first episode psychosis (F20-29, 31; ICD-10) including ethnic minority service users; and EIP staff. Intervention: The team-based motivational engagement (EYE) intervention, derived in consultation with service users, carers & clinicians in the original EYE study, will be delivered by EIP clinicians alongside standardised EIP services, supported by website (www.isanyoneelselikeme.org.uk), training, booklet series, schools pack, friends & family, & social group protocol. Comparator: Standardised EIP service, provided by EIP clinicians, including NICE guidelines approved interventions. Outcomes: Primary outcome is time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact for a consecutive 3-month period). Secondary outcomes include mental & physical health, social & occupational function, recovery, satisfaction & service use at 6, 12, 18 & 24 months. Economic evaluation: 12M within-trial economic evaluation of cost-effectiveness of the EYE intervention from a societal perspective, accounting for cost impacts within and beyond the mental health sector, with a secondary analysis taking a narrower NHS perspective to inform a commissioning guide. Duration 38 months: 9 months set-up & training, 12 months recruitment plus a further 12 months follow-up, 5 months data analysis & dissemination. Benefits and Impact: If effective, integration of the intervention into standardised care will ensure that at least an extra 10% of young people & families with severe mental illness will maintain engagement, resulting in better physical & mental health and economic outcomes. Clinicians, managers & commissioners will benefit from a toolkit including manuals, commissioning guide, training & resources, adapted to meet the needs of the diverse EIP population, and based on an in-depth process evaluation to enable national roll out

Lay abstract: This project is important because around 7,500 young people in England develop psychosis every year. It is a severe mental health problem that generally starts in people aged 14-35 and has long term effects. People who experience psychosis die up to 25 years earlier than the general population from suicide and physical health problems. The financial cost to society is high: £11.8 billion per year. Early Intervention in the first 3 years of psychosis can improve long term outcomes so that people have fewer symptoms and hospital admissions, better health, and reduced suicide risk. A 3-year Early Intervention in psychosis (EIP) service also saves £5,000 per person per year just by reducing hospital admissions, and saves £15 for every £1 spent on EIP services. Yet, at least a quarter of all young people drop out of services in the first 12 months leading to greater risk of poor health and more long term service use. Families also struggle more. Ensuring that young people receive a service quickly is a current NHS priority, but there are no interventions to improve engagement with services. This project is about improving services for people who have a first episode of psychosis so that more people want to stay with the service and benefit from its support. The first Early Youth Engagement (EYE) project developed a new approach with young people, their parents and Early Intervention in Psychosis (EIP) staff. The EYE approach addresses the issues that can put people off services, like the way staff talk with them; how much family & friends are included, and how much it helps with their goals, treatment choices and preferences. The EYE approach includes a website (www.isanyoneelselikeme.org.uk), booklet series co-written with young people, and other resources to support young people & families; and a training programme for staff in how to work flexibly, honestly and openly using key, well established “motivational” techniques to help young people achieve their goals. In our pilot study, more young people were engaged with the new approach at 12 months. Service users and carers said it helped with isolation, trust, personal goals, better communication with the service, shared decision making with staff, and family involvement. The new Early Youth Engagement (EYE) project will build on what was learnt, to test whether the new approach helps young people to stay engaged with services, and whether it saves money, in more NHS services around the UK. It will develop a toolkit to support other services that want to introduce the EYE approach. We will test the EYE approach with 880 young people in 22 EIP services in Manchester, London, Norfolk, Cambridge and the South of England: 11 services will deliver the EYE approach and 11 will work as usual. We will adapt EYE resources for people from ethnic minorities and we will evaluate how the intervention is delivered and resources are used to ensure the best outcomes. The measure of success will be whether more young people stay engaged in the service. We will also test whether they have better mental and physical health, work experience, social life, recovery, service satisfaction, and whether the approach saves money. The study will run for 38 months. Patient and public involvement (PPI) has taken place at every stage of the project and this will continue. It is vital that young people shape the project and co-deliver the research, ensuring its relevance, usefulness and quality.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: MENTAL HEALTH