NCT06359990

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Feb 2024Feb 2027

Study Start

First participant enrolled

February 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 1, 2024

Last Update Submit

April 28, 2026

Conditions

Keywords

Youth violenceSubstance useExperiential avoidanceAfrican AmericanYouthMalesmHealth

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (5)

  • 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

  • The University of Rhode Island Change Assessment Scale (URICA)

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

  • Intensity-of-Care Measurements

    3-months post-intervention

  • Violent Intentions-Teen Conflict Survey

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

Study Arms (2)

BrotherlyACT Intervention Group

EXPERIMENTAL

Three 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.

Behavioral: BrotherlyACT

Waitlist Control Group (WCG)

OTHER

Waitlist Control Group (WCG)

Other: BrotherlyACT Waitlist Control Group (WCG)

Interventions

BrotherlyACTBEHAVIORAL

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 Intervention Group

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

Waitlist Control Group (WCG)

Eligibility Criteria

Age15 Years - 24 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related 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.

    PMID: 37126388BACKGROUND

Related Links

MeSH Terms

Conditions

Substance-Related DisordersTreatment Refusal

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Chuka N Emezue, PhD, MPH

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 1, 2024

First Posted

April 11, 2024

Study Start

February 15, 2024

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

February 15, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
As determined by funders.
Access Criteria
As described above.

Locations