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Early Youth Engagement in First Episode Psychosis (EYE-2) Randomised Controlled Trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51629746
Enrollment
950
Registered
2019-05-10
Start date
2019-05-13
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Young People (14-35 years) with first-episode psychosis (F20-F29

Interventions

The team-based motivational engagement (EYE-2) intervention, is delivered by EIP clinicians, supported by training, an intervention manual, website, 5 booklet series, friends and family involvement, a
(ii) willingness and capacity for involvement as agreed by clinical services
(iii) individual team size of at least 40 new clearly defined first episode cases per year aged 14-35
(iv) currently capturing NHS England mandated routine outcome data
(v) geographical spread to include urban and rural locations, ethnic minority variations, North and South of England. The implementation tool kit is a set of hard copy resources that will be provided
(ii) the 5 booklets (mental health and help-seeking, EIP, for friends and family, treatment choices, getting the most out of hospital)
(iii) the EYE-2 team and individual implementation checklists and (iv) the links to the website and training videos. Whilst the EIP model outlines what should be done, the EYE-2 intervention is comp

Sponsors

Sussex Partnership NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Consecutive referrals to the EIP service during the study recruitment period aged 14-35 years 2. Meeting criteria for a first episode of psychosis (FEP) as determined by each local service according to their own established criteria. The inclusion criteria used to make these decisions will be recorded for each service, and made available for subsequent inspection

Exclusion criteria

Exclusion criteria: 1. A sub-threshold ‘at risk mental state’, not meeting first episode of psychosis criteria 2. Referral over the age of 35 3. Referrals where there is remaining diagnostic uncertainty about psychosis at 12 months 4. Participants will be withdrawn from the study if (i) they move to a mental health service outside the study or (ii) they move to a service that is in a different arm of the EYE project

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary outcomes include mental health, social & occupational function, recovery and satisfaction: 1. Mental health, social and occupational function is measured with the Health of the Nation Outcome Scale (HoNOS) clinician-rated at baseline, 6, 12 (18 and 24 months or until end of study if this is sooner) 2. Recovery is measured by the Questionnaire on the Process of Recovery (QPR) patient-rated at baseline, 6, 12 (18 and 24 months or until end of study if this is sooner) 3. Satisfaction measured by the DIALOG questionnaire at baseline, 6, 12 (18 and 24 months or until end of study if this is sooner) Process evaluation questionnaire data will be collected from all consenting clinicians at three timepoints: 1. An Adapted NOMAD questionnaire will measure attitudes and approaches towards implementation at start, mid and end of the intervention 2. Fidelity will be measured using a bespoke EYE-2 fidelity checklist at start, mid and end of intervention delivery Implementation will also be evaluated qualitatively using a brief semi-structured interview to explore barriers and facilitators to intervention delivery, including context and turbulence, across thee timepoints at start, mid and end of the intervention. Finally, the cost-effectiveness analysis will utilise the: 1. Societal costs measured with the Adult Service Use Schedule collected at 12 months 2. NHS costs measured by case-note data on service use for the period from baseline to 12 months, and by the HoNOS questionnaire data at baseline and 12 months

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026