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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05756855
Enrollment
15
Registered
2023-03-06
Start date
2024-03-19
Completion date
2026-08-31
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

psychosis, schizophrenia, violence, aggression, intervention

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.

Interventions

BEHAVIORALadapted behavioral intervention

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

open pilot clinical trial

Eligibility

Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Acceptability of Intervention Measure (AIM)12 weeksThe 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 weeksThe 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 Attendance12 weeksThe number of EIS participants that attend the cognitive behavioral therapy sessions.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026