Health TrialsbyHealthPanel

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

ConditionsViolence RiskEarly Psychosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorHoward University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Young adults aged 18-30 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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

  • Treatment As Usual (TAU)

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Treatment As Usual (TAU)Other 1 intervention
Group B: TAU + BRAVEExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Working Alliance Inventory - Short Revised (WAI-SR)

The WAI-SR is a validated self-report measure of therapeutic alliance used to assess acceptability and engagement with the BRAVE intervention.

Time frame
Baseline, Week 24

Secondary outcomes

1

Enrollment rate

Enrollment rate defined as the proportion of eligible individuals who provide informed consent and enroll in the study.

Time frame
Randomization to week 24
2

Columbia Initial Screen for Violence

The Columbia Initial Screen for Violence (CIS-V) is a self-report measure assessing violence-related thoughts and behaviors.

Time frame
Baseline, Week 24
3

Retention rate

Retention rate defined as the proportion of enrolled participants who complete the final study assessment.

Time frame
From randomization to Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Howard University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: