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OpenTrials
Active, Not Recruiting

NCT Number: NCT05756855

Young Adults With Violent Behavior During Early Psychosis (Aim 2)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Schizophrenia Aberrant Motor Behavior in Dementia Aggression Behavior Behavioral Symptoms Delusional Disorder Mental Disorders Other Specified Schizophrenia Spectrum and Other Psychotic Disorder Psychotic Disorders Schizo Affective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Paranoid Schizophreniform Disorders Social Behavior

Age range

16 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adapted behavioral intervention

Behavioral

cognitive behavioral therapy based intervention that focuses on anger, violence, and psychosis

Other names: PICASSO

Primary outcomes

  1. 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.

  2. 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.

  3. Number of EIS Participants in Attendance

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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