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Young Adults With Violent Behavior During Early Psychosis

Primary Purpose

Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
adapted behavioral intervention
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia focused on measuring psychosis, schizophrenia, violence, aggression, intervention

Eligibility Criteria

16 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

behavioral intervention

Arm 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.

Outcomes

Primary Outcome Measures

Mean Acceptability of Intervention Measure (AIM)
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)
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
The number of EIS participants that attend the cognitive behavioral therapy sessions.

Secondary Outcome Measures

Full Information

First Posted
February 23, 2023
Last Updated
July 20, 2023
Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05756855
Brief Title
Young Adults With Violent Behavior During Early Psychosis
Official Title
Young Adults With Violent Behavior During Early Psychosis: An Open Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders, Delusional Disorder, Other Specified Schizophrenia Spectrum and Other Psychotic Disorder
Keywords
psychosis, schizophrenia, violence, aggression, intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open pilot clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
behavioral intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
adapted behavioral intervention
Other Intervention Name(s)
PICASSO
Intervention Description
cognitive behavioral therapy based intervention that focuses on anger, violence, and psychosis
Primary Outcome Measure Information:
Title
Mean Acceptability of Intervention Measure (AIM)
Description
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.
Time Frame
12 weeks
Title
Mean Feasibility of Intervention Measure (FIM)
Description
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.
Time Frame
12 weeks
Title
Number of EIS Participants in Attendance
Description
The number of EIS participants that attend the cognitive behavioral therapy sessions.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Rolin, MD, MPH
Phone
212-305-8075
Email
stephanie.rolin@nyspi.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Rolin, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Rolin, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Findings from this study will be presented to research peers, clinicians, and the public through Presentations at Scientific Meetings, Regional Research or Educational Meetings, Newsletters and Social Media and Peer-Reviewed Publications. Those events will occur during or at the conclusion of the study.
IPD Sharing Time Frame
Descriptive and raw data will be submitted on an annual basis. Unpublished de-identified data will be shared within one year after project completion, or when the data are published, whichever is earlier.
IPD Sharing Access Criteria
Data and materials will be made available for research to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with public repositories, including the National Database for Clinical Trials related to Mental Illness (NDCT) and the National Institute of Mental Health (NIMH) Database of Cognitive Training and Remediation Studies (DoCTRS).

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Young Adults With Violent Behavior During Early Psychosis

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