Young Adults With Violent Behavior During Early Psychosis

Not Applicable

Recruiting

• Conditions: Schizophrenia; Schizo Affective Disorder; Delusional Disorder; Other Specified Schizophrenia Spectrum and Other Psychotic Disorder; Schizophreniform Disorders

• Registration Number: NCT05756855
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-06
• Study Start: 2024-03-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2026-06-01
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

• Unable to provide informed consent
• Not fluent (speaking, reading, writing) in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean Acceptability of Intervention Measure (AIM)	12 weeks	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.
Mean Feasibility of Intervention Measure (FIM)	12 weeks	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.
Number of EIS Participants in Attendance	12 weeks	The number of EIS participants that attend the cognitive behavioral therapy sessions.