跳至主要内容
临床试验/NCT06359990
NCT06359990进行中(未招募)不适用

BrotherlyACT: A Culturally Congruent and Technology-Enhanced Youth Violence and Substance Use Intervention for Black Boys and Men

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
2
主要终点
The Reactive-Proactive Aggression Questionnaire (RPQ)

研究概览

简要总结

This study will adapt and test a culturally tailored, multi-component, and trauma-focused digital intervention to reduce the risk and effects of youth violence and substance use and bridge service access gaps for young Black males (YBM) in pediatric emergency and community-based low-resource settings.

详细描述

Across U.S. cities, Black youth face a 20-fold higher risk, and Hispanic youth a 4.4-fold higher risk of fatal shootings compared to non-Hispanic White youth aged 18-24. Despite these disparities, young Black males (YBM) in program-rich cities report reduced service utilization and uptake due to various modifiable personal and community-based factors. Several structural discrimination and avoidance-related processes drive these factors. For instance, YBM report high levels of Service Avoidance (where YBM avoid institutions that might create official records or have law enforcement presence, fearing involvement in the judicial system). At the individual level, they also report Experiential Avoidance (where trauma-impacted YBM suppress uncomfortable thoughts, experiences, and feelings - including openness to intervention - leading to maladaptive coping strategies (e.g., retaliation and substance dependence). These issues jointly amplify youth violence (YV) risk and related issues, such as substance use (SU). Yet, few programs target these personal and structural drivers of YV and SU. The investigator's prior research involving assault-injured YBM has shown a preference for digital and remotely delivered interventions that provide personalized feedback, round-the-clock support, privacy, and integrated services. Digital interventions are an underutilized resource for helping at-risk YBMs overcome some os there personal and structural barriers to utilizing behavioral and other health services.

This research study aims to adapt, validate, and test the efficacy of BrotherlyACT, a culturally tailored, multi-component, and trauma-focused digital intervention to reduce the risk and effects of youth violence and substance use and bridge service access gaps for young Black males (YBM) in pediatric emergency and community-based low-resource settings. This study will recruit a sample of 300 assault-injured YBMs at discharge from three level 1-2 emergency departments (EDs) and violence-involved YBMs from two community-based organizations. Participants will be randomly assigned to the intervention or Waitlist Control Group (WCG). The intervention group will receive the app/web-based BrotherlyACT, comprising three main components: 1) Brief psychoeducational microlearning lesson videos based on the Acceptance and Commitment Therapy (ACT); 2) A Safety Planning Toolkit offering tools for risk assessment, emotional regulation, goal setting, and mindfulness-based stress reduction; 3) A Service Engagement Chatbot (called DEVON) that uses NLP to provide zip-code based navigational support and talk therapy. It is hypothesized that at baseline, 1-, and 3-months post-intervention, the intervention group will demonstrate reductions in 1) YV perpetration (reactive and proactive aggression); 2) YV victimization; 3) substance use (alcohol and other drug use occasions in the past 30 days, substance use attitudes and beliefs). Secondary outcomes include (A) service utilization intensity (e.g., # of weeks receiving follow-up/referral care, # of discriminatory staff-YBM encounters), (B) Experiential Avoidance, (C) Psychological distress, (D) Violence Intentions, and (E) Readiness to Change. This study will explore potential site/location and mediation/moderation effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 24 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Assault-injured youth without impairments (e.g., unstable injuries),
  • Male-identifying, irrespective of sexual orientation;
  • Black/African American hospitalized for injury;
  • Ages 15 to 24 years (inclusive);
  • English literate at a 5th-grade reading level or higher;
  • Able to assent/consent and provide parental consent.

排除标准

  • Currently detained in the criminal justice system,
  • Unable to complete assent/consent forms and assessments due to language barriers, cognitive dysfunction or injury, active psychotic disorder, suicide attempt as the mechanism of injury, and/or current treatment for depression or PTSD,
  • Those presenting with a chief complaint of acute sexual assault, suicidal ideation or attempt, or child maltreatment will be excluded as they already receive other ED services.

结局指标

主要结局

The Reactive-Proactive Aggression Questionnaire (RPQ)

时间窗: Baseline, 1-, and 3-months post-intervention

Change in the perpetration of youth and peer aggression from baseline to follow-up measured with the Reactive-Proactive Aggression Questionnaire (RPQ; Raine et al., 2006) measures two dimensions of aggression in physical or verbal forms. Scores (0, 1, or 2) for proactive aggression items (2,4,6,9,10,12,15, 17,18,20,21,23) and reactive items (1, 3, 5,7,8,11, 13,14, 16,19,22) are summated to form proactive and reactive scales. Proactive and reactive scale scores are summated to obtain total aggression scores. Higher scores obtained from the scale indicate higher levels of aggression.

Change in Attitude toward Substance Use

时间窗: Baseline, 1-, and 3-months post-intervention

Increased awareness of normative beliefs and consequences related to substance use as measured by the Adolescent Attitudes Questionnaire

Multidimensional Peer Victimization Scale (MPVS)

时间窗: Baseline, 1-, and 3-months post-intervention

Change in youth and peer violence victimization from baseline to follow-up measured with the Multidimensional Peer Victimization Scale (MPVS; Mynard \& Joseph, 2000). The MPVS is a 16-item self-report instrument that contains four subscales: physical victimization, verbal victimization, social manipulation, and attacks on property. Each item is scored on a three-point Likert scale, with participants indicating how often they had experienced each of the 16 victimization experiences in the past year. Total victimization scores range from 0 to 32, with subscale scores ranging from 0 to 8. Higher scores indicate that a youth has been subjected to more incidents of peer victimization.

The Alcohol Use Disorders Identification Test (AUDIT)

时间窗: Baseline, 1-, and 3-months post-intervention

The Alcohol Use Disorders Identification Test (AUDIT) focuses on drinking patterns and alcohol-related behaviors. Research supports the use of the AUDIT for adolescents ages 14 to 18, with cut points of 2 for identifying any alcohol problem use and 3 for alcohol misuse or dependence (Knight et al., 2003). WHO recommends a total AUDIT score of ≥8 as an indicator of hazardous and harmful alcohol use, as well as possible alcohol dependence (Thomas F Babor \& Robaina, 2016).

Drug Use Disorders Identification Test (DUDIT)

时间窗: Baseline, 1-, and 3-months post-intervention

Drug Use Disorders Identification Test (DUDIT) is an 11-item tool that is similar to the Alcohol Use Disorders Identification Test (AUDIT), as the DUDIT focuses specifically on drug use and consists of a series of questions designed to evaluate different aspects of drug use behavior and related consequences. As with the AUDIT, items 1 to 9 are scored on a 0 to 4 scale, with the final two questions scored 0, 2, 4. The maximum score is 44. Scoring guidelines suggest that a score of 6 or more among men and 2 or more among women may be indicative of drug-use-related problems. A score of 25 points or more, regardless of sex, strongly indicates dependence.

次要结局

  • Emotional Avoidance Strategy Inventory for Adolescents (EASI-A)(Baseline, 1-, and 3-months post-intervention)
  • The Kessler Psychological Distress Scale (K-10)(Baseline, 1-, and 3-months post-intervention)
  • Intensity-of-Care Measurements(3-months post-intervention)
  • The University of Rhode Island Change Assessment Scale (URICA)(Baseline, 1-, and 3-months post-intervention)
  • Violent Intentions-Teen Conflict Survey(Baseline, 1-, and 3-months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chuka Emezue

Assistant Professor

Rush University Medical Center

研究点 (2)

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