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NCT07417904NARecruiting

BRAVE Program to Improve Safety and Reduce Violence Risk in Early Psychosis

Howard University

Start Date

7/2/2026

Completion Date

8/1/2027

Summary

This study evaluates the feasibility and acceptability of BRAVE, a manualized cognitive behavioral therapy (CBT)-based intervention designed to address dynamic risk factors for violence among young adults with early psychosis. Using a stepped-wedge randomized design, all participants will receive treatment as usual followed by the BRAVE intervention. The study will also explore changes in violence-related behaviors and treatment engagement over time.

Detailed Description

Young adults in the early phase of psychosis are at elevated risk for violent behavior, yet few behavioral interventions have been developed to address modifiable violence-related mechanisms in this population. BRAVE is a brief, manualized CBT-based intervention adapted for delivery within early intervention services. In this stepped-wedge cluster randomized trial, all participants will begin in a treatment-as-usual condition and will be randomly and sequentially transitioned to the BRAVE intervention. Participants will receive weekly BRAVE sessions following completion of the treatment-as-usual period and will continue to receive routine clinical care throughout the study. Study assessments will be conducted at regular intervals across treatment-as-usual, intervention, and follow-up periods. Participants will also identify a collateral informant who will complete study assessments at predefined intervals. The primary objective of this study is to evaluate the feasibility and acceptability of BRAVE. Secondary objectives include examining changes in violence-related behaviors and related clinical and psychosocial outcomes to inform future, fully powered trials.

Eligibility Criteria

Age Range: 16 years to 30 years

Inclusion Criteria: * Young adults aged 16-30 years * Diagnosis of early psychosis * Currently receiving outpatient care through an early psychosis clinic * Psychiatrically stable and deemed appropriate for participation by a treating clinician * Able and willing to provide informed consent Exclusion Criteria: * Unable to provide informed consent * Not fluent in English * History of antisocial behavior, as assessed at baseline * Immediate risk requiring a higher level of care

Interventions

BEHAVIORAL

BRAVE (Behavioral Response Against Violence Engagement)

OTHER

Treatment As Usual (TAU)

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Conditions

Violence RiskEarly Psychosis

Locations

Howard University Hospital

Washington D.C., District of Columbia 20060

United States

Howard University Hospital

Washington D.C., District of Columbia 20060

United States