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Violence in AdolescenceBrotherlyACTNCT06359990

BrotherlyACT: A Tech-Enhanced Violence and Substance Use Intervention for Black Boys and Young Men

A study testing BrotherlyACT in people with Violence in Adolescence and Substance Use, run by Rush University Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 15 to 24 years, men onlyHealthy volunteers can take part
What is being tested?
BrotherlyACT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
15 Feb 2024to 15 Feb 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 15 to 24 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rush University Medical Center

    Chicago, Illinois, 60612

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
BrotherlyACT, BrotherlyACT Waitlist Control Group (WCG)
Keywords
Youth violence, Substance use, Experiential avoidance, African American, Youth, Males, mHealth
Medical subject headings
Substance-Related Disorders, Treatment Refusal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrotherlyACTBehavioural

    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.

  • BrotherlyACT Waitlist Control Group (WCG)Other

    During the waiting period, participants in the control group do not receive the BrotherlyACT intervention but may continue with their usual activities or interventions.

Study groups in NCT06359990
Study groupRoleWhat they receive
BrotherlyACT Intervention GroupExperimentalThree components make up BrotherlyACT: 1) Brief psychoeducational modules adapted from an evidence-based violence prevention program; 2) A Safety Planning Toolkit offering tools for risk assessment, mood tracking, goal setting, and mindfulness-based stress reduction; 3) A Service Engagement Chatbot that uses NLP to provide zip-code based navigational support and talk therapy.
Receives: Behavioral: BrotherlyACT
Waitlist Control Group (WCG)OtherWaitlist Control Group (WCG)
Receives: Other: BrotherlyACT Waitlist Control Group (WCG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 1-, and 3-months post-intervention

  2. 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.

    Measured: Baseline, 1-, and 3-months post-intervention

  3. 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).

    Measured: Baseline, 1-, and 3-months post-intervention

  4. 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.

    Measured: Baseline, 1-, and 3-months post-intervention

  5. Change in Attitude toward Substance Use

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

    Measured: Baseline, 1-, and 3-months post-intervention

Secondary outcomes (5)
  1. 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.

    Measured: Baseline, 1-, and 3-months post-intervention

  2. 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.

    Measured: Baseline, 1-, and 3-months post-intervention

  3. 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).

    Measured: Baseline, 1-, and 3-months post-intervention

  4. 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.

    Measured: 3-months post-intervention

  5. 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.

    Measured: Baseline, 1-, and 3-months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start15 Feb 2024
  3. Primary completion15 Feb 2027 (estimated)
  4. Study completion15 Feb 2027 (estimated)

Resources

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06359990
Sponsor's protocol ID
RushUMCEmezue
Acronym
BrotherlyACT
Status last verified
Apr 2026
First submitted
1 Apr 2024
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Aggregated and de-identified IPD may be made available to other scientists, policymakers, and programs/critical stakeholders working with racial and ethnic minority youth and violence prevention. Toward this end, we will create a database of all participant data, removing personal identifiers or links to participants. This database will be shared with requesters as appropriate. The purpose of the database is to enable additional exploratory analyses that may lead to additional oral presentations at scientific conferences and manuscripts. As new findings emerge from the study, we will make possible secondary analyses to explore the data further. For researchers, programs, and others who would like to use BrotherlyACT in their setting, we will work with the Rush University tech ventures office to develop a materials transfer agreement with acknowledgment of funding sources as appropriate.

Publications

  • 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.

    PubMed 37126388
  • Emezue C, Dan-Irabor D, Froilan A, Dunlap A, Zamora P, Negron S, Simmons J, Watkins J, Julion WA, Karnik NS. Evaluating an App-Based Intervention for Preventing Firearm Violence and Substance Use in Young Black Boys and Men: Usability Evaluation Study. JMIR Form Res. 2024 Nov 26;8:e60918. doi: 10.2196/60918.

    PubMed 39589765

Questions about this trial

What is this clinical trial studying?

A study testing BrotherlyACT in people with Violence in Adolescence and Substance Use, run by Rush University Medical Center at 1 site 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Reactive-Proactive Aggression Questionnaire (RPQ) (time frame: Baseline, 1-, and 3-months post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06359990, which also lists 2 linked publications.

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 Apr 2026.

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