Recruiting

BRAVE

Sponsor:

Howard University

Code:

NCT07417904

Conditions

Violence Risk

Early Psychosis

Eligibility Criteria

Sex: All

Age: 16 - 30

Healthy Volunteers: Not accepted

Interventions

BRAVE (Behavioral Response Against Violence Engagement)

Treatment As Usual (TAU)

Study Details

Brief 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.

Conditions

Violence Risk

Early Psychosis

Study ID

NCT07417904

Start date

Jul 2, 2026

Status verified date

Jul, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 30

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Treatment As Usual (TAU)

Participants will receive routine clinical care provided by early psychosis services.

experimental: TAU + BRAVE

Participants will receive BRAVE, a manualized CBT-based behavioral intervention, in addition to treatment as usual. BRAVE consists of weekly sessions delivered within early psychosis services and targets modifiable risk factors for violence.

Interventions

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.

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.

Primary outcome measure

  • Working Alliance Inventory - Short Revised (WAI-SR) [ Time Frame: Baseline, Week 24 ]

Central Contacts and Locations

Central contacts

Stephanie Rolin, MD MPH

(202) 865-6100stephanie.rolin@howard.edu

Locations

Howard University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20060

Contacts

Stephanie Rolin, MD MPH

(202) 865-6100stephanie.rolin@howard.edu

More Information

Sponsor

Howard University

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • early psychosis
  • violence risk
  • aggression
  • cognitive behavioral therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Howard University on 2026-07-29.