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

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Columbia University

Status

Active, not recruiting

Conditions

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

Treatments

Behavioral: adapted behavioral intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05756855
NYSPI 8451
K23MH126312 (U.S. NIH Grant/Contract)
AAAU8528

Details and patient eligibility

About

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

Full 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.

Enrollment

15 patients

Sex

All

Ages

16 to 30 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

behavioral intervention
Experimental group
Description:
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.
Treatment:
Behavioral: adapted behavioral intervention

Trial contacts and locations

1

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Central trial contact

Stephanie Rolin, MD, MPH

Data sourced from clinicaltrials.gov

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