NCT07417904

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Jul 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026Aug 2027

First Submitted

Initial submission to the registry

February 2, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 2, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

February 2, 2026

Last Update Submit

July 28, 2026

Conditions

Violence RiskEarly Psychosis

Keywords

early psychosisviolence riskaggressioncognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • Working Alliance Inventory - Short Revised (WAI-SR)

    The WAI-SR is a 12-item self-report measure of therapeutic alliance. Items assess agreement on therapeutic goals and tasks and the participant-therapist bond. Total scores range from 12 to 60, with higher scores indicating a stronger therapeutic alliance.

    Baseline, Week 24

Secondary Outcomes (3)

  • Enrollment rate

    Randomization to week 24

  • Columbia Initial Screen for Violence

    Baseline, Week 24

  • Retention rate

    From randomization to Week 24

Study Arms (2)

Treatment As Usual (TAU)

OTHER

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

Other: Treatment As Usual (TAU)

TAU + BRAVE

EXPERIMENTAL

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.

Behavioral: BRAVE (Behavioral Response Against Violence Engagement)Other: Treatment As Usual (TAU)

Interventions

Treatment As Usual (TAU)OTHER

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.

TAU + BRAVETreatment As Usual (TAU)
BRAVE (Behavioral Response Against Violence Engagement)BEHAVIORAL

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.

TAU + BRAVE

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Howard University Hospital

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

NOT YET RECRUITING

Howard University Hospital

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

RECRUITING

MeSH Terms

Conditions

Psychotic DisordersAggression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Central Study Contacts

Stephanie Rolin, MD MPH

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: design type: stepped wedge
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 18, 2026

Study Start

July 2, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to the sensitive nature of the data collected, including information related to violence risk and mental health, and the potential risk of re-identification. De-identified summary data will be reported in publications.

Locations

US(2)