Young Adults and Violent Behavior During Early Psychosis (Aim 3)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Working Alliance Inventory - Short Revised (WAI-SR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment As Usual (TAU)
Participants will receive routine clinical care provided by early psychosis services.
干预措施: Treatment As Usual (TAU) (Other)
TAU + BRAVE
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.
干预措施: BRAVE (Behavioral Response Against Violence Engagement) (Behavioral)
TAU + BRAVE
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.
干预措施: Treatment As Usual (TAU) (Other)
结局指标
主要结局
Working Alliance Inventory - Short Revised (WAI-SR)
时间窗: 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.
次要结局
- Columbia Initial Screen for Violence(Baseline, Week 24)
- Enrollment rate(Randomization to week 24)
- Retention rate(From randomization to Week 24)