Young Adults With Violent Behavior During Early Psychosis

Study Overview
=================
Brief Summary
-----------------
This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.

Detailed Description
-----------------
The investigators will conduct an open pilot trial of a behavioral intervention to reduce violent behavior within the OnTrackNY network. The focus of this open pilot is to explore the acceptability and feasibility of the intervention. The study will enroll early intervention service (EIS) clinician - EIS participant dyads. The planned sample size is 3-4 EIS clinicians and 10-16 EIS participants (up to n=16 dyads). This real-world open pilot will provide feedback to help tailor the intervention to the OnTrackNY setting.

Official Title
-----------------
Young Adults With Violent Behavior During Early Psychosis: An Open Pilot Trial

Conditions
-----------------
Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders, Delusional Disorder, Other Specified Schizophrenia Spectrum and Other Psychotic Disorder

Intervention / Treatment
-----------------
* Behavioral: adapted behavioral intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for EIS participants: Ages 16 to 30 who have experienced nonaffective psychosis with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, other specified/unspecified schizophrenia spectrum and other psychotic disorders (International Classification of Disease Clinical Modification (ICD-10-CM) Diagnosis Code F20.x) Receive First Episode Psychosis (FEP) treatment in one of OnTrackNY clinics/sites with an eligible EIS clinicians Willing to participate in research interviews after each study visit during the study period Exclusion Criteria: Unable to provide informed consent Not fluent (speaking, reading, writing) in English

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: open pilot clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: behavioral intervention<br>This will involve conducting a 12-week open pilot trial (up to n=16 dyads of EIS clinicians-EIS participants) to test the feasibility and acceptability of the adapted Psychological Interventions for Coping with Anger and Schizophrenia: a study of outcomes (PICASSO) intervention in the OnTrackNY setting. | Behavioral: adapted behavioral intervention<br>* cognitive behavioral therapy based intervention that focuses on anger, violence, and psychosis<br>* Other names: PICASSO;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Acceptability of Intervention Measure (AIM) | The AIM is a 4-item measure of the acceptability of the intervention, to be completed by EIS clinicians. Scores range from 1-4 with higher score indicating high acceptability. | 12 weeks | 
| Mean Feasibility of Intervention Measure (FIM) | The FIM is a 4-item measure of the feasibility of the intervention, to be completed by EIS clinicians. Scores range from 1-4 with higher score indicating high feasibility. | 12 weeks | 
| Number of EIS Participants in Attendance | The number of EIS participants that attend the cognitive behavioral therapy sessions. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychosis, schizophrenia, violence, aggression, intervention