An interventional study of BRAVE (Behavioral Response Against Violence Engagement) and Treatment As Usual (TAU) in Violence Risk and Early Psychosis, sponsored by Howard University. Recruiting at 2 sites in United States. Open to participants aged 16 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Howard University · Not applicable, Interventional, and Prevention
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.
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.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
This study's planned enrollment of 30 is below the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Howard University is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive routine clinical care provided by early psychosis services.
Other: Treatment As Usual (TAU)
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)
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 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.
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 24
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
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 24
Retention rate
Retention rate defined as the proportion of enrolled participants who complete the final study assessment.
Time frame: From randomization to Week 24
Plan to share: No — 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.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Aug 2027, 13 months after the start.
Of 455 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 13 months is below that.
Counting every sponsor, half of 457 studies reached it within 34 months; a quarter within 19 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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