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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06359990
Other study ID # RushUMCEmezue
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2024
Est. completion date February 15, 2026

Study information

Verified date April 2024
Source Rush University Medical Center
Contact Chuka N Emezue, PhD, MPH
Phone 312-942-6151
Email chuka_emezue@rush.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date February 15, 2026
Est. primary completion date February 15, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 15 Years to 24 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
BrotherlyACT
BrotherlyACT is a digital intervention to prevent youth violence and substance use among trauma-exposed young Black males, ages 125-24. This intervention combines life skills coaching, safety planning tools, and an AI-driven chatbot to reduce the risk and effects of violence and early substance use.
Other:
BrotherlyACT Waitlist Control Group (WCG)
During the waiting period, participants in the control group do not receive the BrotherlyACT intervention but may continue with their usual activities or interventions.

Locations

Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Reactive-Proactive Aggression Questionnaire (RPQ) 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. Baseline, 1-, and 3-months post-intervention
Primary Multidimensional Peer Victimization Scale (MPVS) 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. Baseline, 1-, and 3-months post-intervention
Primary The Alcohol Use Disorders Identification Test (AUDIT) 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). Baseline, 1-, and 3-months post-intervention
Primary Drug Use Disorders Identification Test (DUDIT) 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. Baseline, 1-, and 3-months post-intervention
Primary Change in Attitude toward Substance Use Increased awareness of normative beliefs and consequences related to substance use as measured by the Adolescent Attitudes Questionnaire Baseline, 1-, and 3-months post-intervention
Secondary Emotional Avoidance Strategy Inventory for Adolescents (EASI-A) Change in Experiential avoidance from baseline to follow-up measured using the Emotional Avoidance Strategy Inventory for Adolescents (EASI-A). The EASI-A has three subscales: Avoidance of Thoughts and Feelings, Avoidance of Emotion Expression, and Active Avoidance Coping. Baseline, 1-, and 3-months post-intervention
Secondary The Kessler Psychological Distress Scale (K-10) Change in psychological distress from baseline to follow-up will be assessed using the Kessler Psychological Distress Scale (K10). Psychological Distress will be measured on a scale from five to one (5=all of the time; 4= Most of the time; 3 some of the time; 2= A little of the time; 1= none of the time). The scores range from 6 to 30, and the total scores are calculated by summing the individual items. Higher scores indicate high psychological distress. Baseline, 1-, and 3-months post-intervention
Secondary The University of Rhode Island Change Assessment Scale (URICA) The University of Rhode Island Change Assessment Scale (URICA) is a 32-item self-report measure that includes four subscales measuring the stages of change or readiness to change: Precontemplation, Contemplation, Action, and Maintenance (there is also a 24-item version). Responses are given on a 5-point Likert scale ranging from (1=strong disagreement to 5=strong agreement), McConnaughy et al., 1983). Baseline, 1-, and 3-months post-intervention
Secondary Intensity-of-Care Measurements Based on a 3-part measurement developed by the Children's Hospital of Philadelphia (CHOP) and the more standard intensity measurements of total time used by the San Francisco WrapAround care program and Healing Hurt People Program (HHP) in Philadelphia. This measurement includes 1) # of weeks receiving care, 2) # of needs addressed, and 3) # of staff-client encounters, 4) # of discriminatory staff-YBM encounters. 3-months post-intervention
Secondary Violent Intentions-Teen Conflict Survey Measures intentions to use nonviolent strategies to control anger and conflict. These items measure intentions to use nonviolent strategies to control anger and conflict. Respondents are asked to indicate how likely they would be to adopt certain nonviolent behaviors the next time they get angry. Responses are summed' with a possible range of 8 to 32. High scores indicate a stronger intention to use non-violent strategies. Baseline, 1-, and 3-months post-intervention
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