BRAVE Program to Improve Safety and Reduce Violence Risk in Early Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-30
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 volunteersQualifiers
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
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)
BehavioralBRAVE 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 interventionTreatment 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 groupsGroup 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 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.
Time frame
Baseline, Week 24Secondary 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 242
Columbia Initial Screen for Violence
The Columbia Initial Screen for Violence is a self-report measure assessing violence-related thoughts and behaviors. Items assess whether specific violence-related thoughts or behaviors occurred and, where applicable, their frequency during the assessment period. Outcomes will be reported as the presence and frequency of violence-related thoughts and behaviors; higher frequencies indicate more frequent violence-related experiences.
Time frame
Baseline, Week 243
Retention rate
Retention rate defined as the proportion of enrolled participants who complete the final study assessment.
Time frame
From randomization to Week 24Sponsors 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