Young Adults With Violent Behavior During Early Psychosis

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

adapted behavioral intervention

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

NCT ID

NCT05756855

First Posted

February 23, 2023

Last Updated

July 20, 2023

Sponsor

Columbia University

Collaborators

National Institute of Mental Health (NIMH)

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).

Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial