Clinical trial NCT06359990: BrotherlyACT: A Tech-Enhanced Violence and Substance Use Intervention for Black Boys and Young Men
Official title: BrotherlyACT: A Culturally Congruent and Technology-Enhanced Youth Violence and Substance Use Intervention for Black Boys and Men
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Violence in Adolescence
Substance Use
Avoidance of Healthcare
Keywords: Youth violence
Substance use
Experiential avoidance
African American
Youth
Males
mHealth
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 300
Sex: MALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Currently detained in the criminal justice system,
2. 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,
3. 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.

Primary outcomes:
measure: The Reactive-Proactive Aggression Questionnaire (RPQ)
timeFrame: Baseline, 1-, and 3-months post-intervention
measure: Multidimensional Peer Victimization Scale (MPVS)
timeFrame: Baseline, 1-, and 3-months post-intervention
measure: The Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline, 1-, and 3-months post-intervention
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Baseline, 1-, and 3-months post-intervention
measure: Change in Attitude toward Substance Use
timeFrame: Baseline, 1-, and 3-months post-intervention
Secondary outcomes:
measure: Emotional Avoidance Strategy Inventory for Adolescents (EASI-A)
timeFrame: Baseline, 1-, and 3-months post-intervention
measure: The Kessler Psychological Distress Scale (K-10)
timeFrame: Baseline, 1-, and 3-months post-intervention
measure: The University of Rhode Island Change Assessment Scale (URICA)
timeFrame: Baseline, 1-, and 3-months post-intervention
measure: Intensity-of-Care Measurements
timeFrame: 3-months post-intervention
measure: Violent Intentions-Teen Conflict Survey
timeFrame: Baseline, 1-, and 3-months post-intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Chuka N Emezue, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Emezue C, Karnik NS, Reeder B, Schoeny M, Layfield R, Zarling A, Julion W. A Technology-Enhanced Intervention for Violence and Substance Use Prevention Among Young Black Men: Protocol for Adaptation and Pilot Testing. JMIR Res Protoc. 2023 May 1;12:e43842. doi: 10.2196/43842.