NCT07417904

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

Young Adults and Violent Behavior During Early Psychosis (Aim 3)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Howard University · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Violence Risk
• Early Psychosis

Interventions

Type	Name	Description
BEHAVIORAL	BRAVE (Behavioral Response Against Violence Engagement)	BRAVE is a brief, manualized cognitive behavioral therapy (CBT)-based behavioral intervention designed to address modifiable risk factors associated with violence risk among young adults with early psychosis. The intervention is delivered as weekly sessions within early psychosis services and focuses on enhancing treatment engagement, emotional regulation, cognitive flexibility, and behavioral coping strategies related to aggression and violence risk. Participants continue to receive treatment as usual throughout the study.
OTHER	Treatment As Usual (TAU)	Treatment as usual consists of routine outpatient clinical care provided by early psychosis services, including psychiatric medication management and psychosocial services, as determined by the treating clinical team. No study-specific intervention is delivered during this condition.

Timeline

• Start date: 2026-02-16
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States