Statistical analysis plan for the Early Youth Engagement in first episode psychosis (EYE-2) study: a pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement

Jones, Christopher Iain, Bremner, Stephen, Hooper, Richard, Gu, Jenny, Bartl, Gergely and Greenwood, Kathryn (2021) Statistical analysis plan for the Early Youth Engagement in first episode psychosis (EYE-2) study: a pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement. Trials, 22. a732 1-8. ISSN 1745-6215

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Abstract

Background
Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and health services. This study will evaluate the effectiveness of a team-based motivational engagement intervention, the Early Youth Engagement (EYE-2) intervention.

Methods and design
The EYE-2 trial is a cluster randomised controlled trial comparing the EYE-2 intervention plus standardised EIP service to standardised EIP service alone, with randomisation at the clinical team (cluster) level. The study aimed to enrol 950 young people (aged 14–35 years) with first episode psychosis in 10 teams per arm.

Results
The primary outcome is time to disengagement: days from the date of allocation to care coordinator to date of the last contact following either refusal to engage with an EIP team or lack of response to EIP contact for 3 consecutive months which will be analysed using a shared frailty model. Secondary outcomes are Health of the Nation Outcome Scale (HoNOS), Process of Recovery Questionnaire (QPR), DIALOG (a service user-reported measure of quality of life and treatment satisfaction) and service use outcomes which will be analysed using mixed effects regression models.

Discussion
This paper is the detailed statistical analysis plan for the EYE-2 trial. Any changes to, or deviations from, this plan will be described and justified in the final trial report.

Trial registration
ISRCTN 51629746. Prospectively registered on 7 May 2019. Date assigned 10 May 2019.

Item Type: Article
Keywords: Cluster randomised trial, Early intervention, Engagement, Intervention, Psychosis, Statistical analysis plan, Adolescent, Cost-Benefit Analysis, Humans, Mental Health, Motivation, Psychotic Disorders, Quality of Life
Schools and Departments: Brighton and Sussex Medical School > Primary Care and Public Health
School of Psychology > Psychology
SWORD Depositor: Mx Elements Account
Depositing User: Mx Elements Account
Date Deposited: 17 Nov 2021 08:07
Last Modified: 17 Nov 2021 08:15
URI: http://sro.sussex.ac.uk/id/eprint/102947

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