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Clinical Trials/NCT05756855
NCT05756855
Active, not recruiting
Not Applicable

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

Columbia University1 site in 1 country15 target enrollmentMarch 19, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Columbia University
Enrollment
15
Locations
1
Primary Endpoint
Mean Acceptability of Intervention Measure (AIM)
Status
Active, not recruiting
Last Updated
7 months ago

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.

Registry
clinicaltrials.gov
Start Date
March 19, 2024
End Date
August 31, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul S. Appelbaum

Elizabeth K. Dollard Professor of Psychiatry, Medicine and Law

Columbia University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

Mean Acceptability of Intervention Measure (AIM)

Time Frame: 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)

Time Frame: 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

Time Frame: 12 weeks

The number of EIS participants that attend the cognitive behavioral therapy sessions.

Study Sites (1)

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