Piloting the 'Youth Early-intervention Study' ('YES'): Preliminary functional outcomes of a randomized controlled trial targeting social participation and physical well-being in young people with emerging mental disorders.

Abstract Introduction . Young people with mental disorders present with diverse social, vocational, physical, and developmental needs. However, multifaceted interventions are rare. We examine the effectiveness of a clinical trial targeting social participation and physical well-being in young people accessing clinical services. Methods . The ‘Youth Early-intervention Study’ (‘YES’) was an unblinded, two-phase, pilot randomized controlled trial offered as an adjunct to standard clinical care, consisting of group activities. Mixed effects models were used to examine functional outcomes over time measured by the ‘Social and Occupational Functioning Assessment Scale’, ‘Functioning Assessment Short Test’, and ‘Brief Disability Questionnaire’ (items 7 and 8). Results . 133 participants aged 14-25 were recruited. 87 participants completed both arms and 83 participants completed a 12-month post-trial assessment. Functioning improved across all outcomes. While diagnoses differed in functioning at baseline (lower functioning in psychotic and bipolar disorders compared to depression), they did not differ in the rate of improvement across any measure. Randomization groups did not differ in baseline functioning or the rate of improvement, suggesting a non-specific impact of the intervention. Engagement with education increased from 11% at baseline to 51% at 12-months post-trial and full-time employment increased from 8% at baseline to 20% at 12-months post-trial. Limitations . Small sample, no control group, and unmeasured potential moderators (e.g. neurocognitive impairment). Conclusions . ‘YES’ was effective and preliminary positive outcomes were observed across all functional outcomes. Future studies should compare the ‘YES’ intervention to a treatment-as-usual control condition and conduct a multi-centre trial across early intervention service sites.