Behavioral intervention for young adults with violent behavior during early psychosis
Young Adults with Violent Behavior During Early Psychosis: an Open Pilot Trial
This study is testing a new program to help young adults with early psychosis reduce violent behavior and see how well it works in real-life situations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 16 Years to 30 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05756855 on ClinicalTrials.gov |
What this trial studies
This study aims to implement a behavioral intervention designed to reduce violent behavior in young adults experiencing early psychosis. It will involve an open pilot trial within the OnTrackNY network, focusing on the acceptability and feasibility of the intervention. The study will enroll clinician-participant dyads, with a planned sample size of 3-4 clinicians and 10-16 participants, to gather real-world feedback and tailor the intervention accordingly.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 16 to 30 diagnosed with nonaffective psychosis, including schizophrenia and related disorders, who are receiving treatment at OnTrackNY clinics.
Not a fit: Patients who are unable to provide informed consent or are not fluent in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce violent behavior in young adults with early psychosis, improving their overall treatment outcomes.
How similar studies have performed: While this approach is novel in its specific focus on violent behavior in early psychosis, similar interventions targeting aggression in psychotic disorders have shown promise in other studies.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
New York, New York
- New York State Psychiatric Institute — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Rolin, MD, MPH — Columbia University
- Study coordinator: Stephanie Rolin, MD, MPH
- Email: stephanie.rolin@nyspi.columbia.edu
- Phone: 212-305-8075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.