An open pilot trial of a behavioural intervention to reduce violence by young adults with early psychosis receiving treatment in an early intervention services setting: A protocol.

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Despite the public health impact of violence among young adults with psychosis, behavioural interventions to reduce the risk of engaging in violence remain rare. For young adults with early psychosis, cognitive behavioural therapy (CBT)-based psychotherapy has efficacy in reducing impairment and improving functioning. However, no CBT-based intervention to reduce violence has been formally adapted for young adults with early psychosis. This protocol outlines the first clinical trial of a behavioural intervention to reduce violence for young adults with early psychosis. This study is set in an early intervention services (EIS) setting and seeks to adapt and pilot Psychological Intervention for Complex PTSD and Schizophrenia-Spectrum Disorder (PICASSO), a CBT-based intervention, through an iterative process utilizing mixed-methods assessments. All research will occur at OnTrackNY, the largest EIS program in the United States. This study will consist of an open pilot trial, with four EIS clinicians delivering the intervention to one to two EIS participants per round. In this mixed-methods study, both quantitative measures (acceptability, feasibility and hypothesized mediators of target outcome collected on a weekly basis) and qualitative interviews (with EIS clinicians at weeks 4, 8 and 12) will be conducted. Transcripts will be analyzed using thematic content analysis. Two to three rounds of iterative modifications are anticipated (n = 10-16 EIS participants total). Recruitment began in February 2024 and is expected to continue over a 9-12-month period. Because violent behaviour causes interpersonal disruptions such as incarceration and increased caregiver burden, an innovative intervention to reduce violence risk could have broader health impact for this vulnerable population. Adapting the PICASSO intervention to the EIS setting will optimize its acceptability and feasibility by the intended target population.