Violence RiskBRAVENCT07417904
BRAVE Program to Improve Safety and Reduce Violence Risk in Early Psychosis
A study testing BRAVE (Behavioral Response Against Violence Engagement) and Treatment As Usual (TAU) in people with Violence Risk and Early Psychosis, run by Howard University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Violence Risk, Early Psychosis
- What is being tested?
- BRAVE (Behavioral Response Against Violence Engagement) and Treatment As Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jul 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Howard University Hospital
Washington D.C., District of Columbia, 20060
Stephanie Rolin, MD MPH, (202) 865-6100, stephanie.rolin@howard.edu
- Recruiting
Howard University Hospital
Washington D.C., District of Columbia, 20060
Stephanie Rolin, MD MPH, (202) 865-6100, stephanie.rolin@howard.edu
About this study
Official title: Young Adults and Violent Behavior During Early Psychosis (Aim 3)
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.
Read the detailed description
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.
- Conditions
- Violence Risk, Early Psychosis
- Being tested
- BRAVE (Behavioral Response Against Violence Engagement), Treatment As Usual (TAU)
- Keywords
- early psychosis, violence risk, aggression, cognitive behavioral therapy
- Medical subject headings
- Psychotic Disorders, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRAVE (Behavioral Response Against Violence Engagement)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | Other | Participants will receive routine clinical care provided by early psychosis services. Receives: 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. Receives: Behavioral: BRAVE (Behavioral Response Against Violence Engagement); Other: Treatment As Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 24
Secondary outcomes (3)
Enrollment rate
Enrollment rate defined as the proportion of eligible individuals who provide informed consent and enroll in the study.
Measured: 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.
Measured: Baseline, Week 24
Retention rate
Retention rate defined as the proportion of enrolled participants who complete the final study assessment.
Measured: From randomization to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start2 Jul 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- design type: stepped wedge
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Howard University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417904
- Sponsor's protocol ID
- IRB-2025-1976
- Other IDs
- K23MH126312
- Acronym
- BRAVE
- Status last verified
- Jul 2026
- First submitted
- 2 Feb 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Adults and Violent Behavior During Early Psychosis (Aim 3)
- ClinicalTrials.gov ID
- NCT07417904
- Acronym / sponsor ID
- BRAVE / IRB-2025-1976
- Conditions
- Violence Risk, Early Psychosis
- Keywords
- early psychosis, violence risk, aggression, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Howard UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- design type: stepped wedge
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | Other | Other: Treatment As Usual (TAU)Participants will receive routine clinical care provided by early psychosis services. |
| TAU + BRAVE | Experimental | Behavioral: BRAVE (Behavioral Response Against Violence Engagement), 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. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | TAU + BRAVE |
| 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. | Other | TAU + BRAVE, Treatment As Usual (TAU) |
Primary outcome
Working Alliance Inventory - Short Revised (WAI-SR)
Time frame: Baseline, Week 24
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.
3 secondary outcomes
Enrollment rate
Time frame: Randomization to week 24
Columbia Initial Screen for Violence
Time frame: Baseline, Week 24
Retention rate
Time frame: From randomization to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRAVE (Behavioral Response Against Violence Engagement) and Treatment As Usual (TAU) in people with Violence Risk and Early Psychosis, run by Howard University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Rolin, MD MPH ((202) 865-6100, stephanie.rolin@howard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working Alliance Inventory - Short Revised (WAI-SR) (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.