BrotherlyACT for Youth Violence and Substance Use

(BrotherlyACT Trial)

Overseen By Chuka N Emezue, PhD, MPH

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Detained, Language barriers, Cognitive dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital program called BrotherlyACT, designed to reduce youth violence and substance use among young Black males. The program includes educational modules, stress and mood management tools, and a chatbot for locating local services. Participants will either receive the program or be placed on a waitlist. It suits Black males aged 15 to 24 who have been hospitalized for an injury and can read English at a basic level. As an unphased trial, this study allows participants to contribute to innovative research aimed at improving community health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the BrotherlyACT intervention is safe for young Black males?

Research has shown that the BrotherlyACT program, a digital tool for addressing youth violence and substance use, has undergone testing in earlier studies. These studies evaluated its safety and effectiveness for young people. Early results suggest that the program is generally easy to use, with participants reporting no major negative effects. The program includes learning modules, a safety planning toolkit, and a chatbot for support, all designed to reduce risks and provide help simply. Overall, evidence suggests that BrotherlyACT is a safe choice for those considering participation in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BrotherlyACT because it offers a fresh approach to tackling youth violence and substance use. Unlike standard treatments, which often involve lengthy counseling sessions, BrotherlyACT combines brief psychoeducational modules with a Safety Planning Toolkit and a Service Engagement Chatbot. This innovative use of technology provides personalized, on-demand support, including risk assessment and mood tracking, to help young people manage stress and set goals. By integrating mindfulness techniques and leveraging natural language processing for therapy, BrotherlyACT aims to engage youth in a more interactive and accessible way than traditional methods.

What evidence suggests that BrotherlyACT is effective for reducing youth violence and substance use?

Research shows that BrotherlyACT, which participants in this trial may receive, might help reduce violence and substance use among young people. Studies have found that similar technology-based programs can empower youth by teaching important life skills and reducing risky behaviors. BrotherlyACT combines technology with Acceptance and Commitment Therapy (ACT), which has improved mental health in other contexts. Early results from similar programs suggest they can help young people manage emotions and make safer choices. This digital program includes tools like mood tracking and stress reduction, specifically designed to support young Black males in challenging environments. ^{2 3 4 5 6}

Who Is on the Research Team?

Chuka N Emezue, PhD, MPH

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for young Black males who may be at risk of or affected by youth violence and substance use. It aims to help those in low-resource communities, particularly those who visit pediatric emergency services.

Inclusion Criteria

Black/African American hospitalized for injury

English literate at a 5th-grade reading level or higher

Assault-injured youth without impairments (e.g., unstable injuries)

Exclusion Criteria

Currently detained in the criminal justice system

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

I am able to understand and sign consent forms without language, mental health, or cognitive issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BrotherlyACT digital intervention, including psychoeducational modules, a Safety Planning Toolkit, and a Service Engagement Chatbot

3 months

Baseline, 1-month, and 3-month follow-ups

Follow-up

Participants are monitored for changes in youth violence, substance use, and psychological outcomes

3 months

1-month and 3-month follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• BrotherlyACT

Trial Overview The study is testing BrotherlyACT, a culturally tailored digital intervention designed to reduce youth violence and substance use among participants. The effectiveness will be compared with a waitlist control group that does not receive the intervention immediately.

How Is the Trial Designed?

Group I: Waitlist Control Group (WCG) Experimental Treatment 1 Intervention

Waitlist Control Group (WCG)

Group II: BrotherlyACT Intervention Group Experimental Treatment 1 Intervention

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.

BrotherlyACT is already approved in United States for the following indications:

Approved in United States as BrotherlyACT for:

• Youth violence prevention
• Substance use prevention

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

Integrated Family and Cognitive-Behavioral Therapy (IFCBT) significantly reduced substance use in adolescents compared to the Drugs Harm Psychoeducation curriculum (DHPE), with IFCBT participants using alcohol an average of 2.03 days per month versus 6.06 days for DHPE participants, and marijuana 5.67 days versus 13.83 days, respectively.

IFCBT not only decreased substance use but also improved psychosocial skills in youth and adaptive communication and involvement in parents, indicating its effectiveness in addressing both individual and family dynamics in treating adolescent drug abuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated family and cognitive-behavioral therapy for adolescent substance abusers: a stage I efficacy study. Latimer, WW., Winters, KC., D'Zurilla, T., et al.[2019]

The young adult adaptation of multidimensional family therapy (MDFT) was found to be feasible and effective, with 95% of the 22 participants completing the treatment and reporting high satisfaction.

Participants showed significant reductions in substance use, improved vocational functioning (with a 73% increase in full-time employment), and a notable decrease in legal issues, as 86% had no rearrests over 18 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidimensional Family Therapy for Justice-Involved Young Adults with Substance Use Disorders. Liddle, HA., Dakof, G., Rowe, C., et al.[2023]

The study involving 83 parent-youth dyads showed that a combined electronic and in-person intervention aimed at reducing marijuana use among justice-involved youth was feasible and well-accepted, with a retention rate of about 75%.

Despite the high acceptability of the intervention, it did not lead to significant reductions in marijuana use or related outcomes, indicating that more intensive treatment approaches may be needed for effective results in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention for marijuana using, court-involved non-incarcerated youth. Kemp, K., Micalizzi, L., Becker, SJ., et al.[2023]

The Parent SMART intervention, which combines an online parenting program with coaching and networking, was found to be acceptable and feasible for engaging parents of adolescents in residential treatment for substance-related issues.

Preliminary results suggest that adolescents in short-term residential care whose parents participated in Parent SMART had fewer days of alcohol use and fewer school problems compared to those whose parents only received traditional treatment, indicating potential effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent SMART (Substance Misuse in Adolescents in Residential Treatment): Pilot randomized trial of a technology-assisted parenting intervention. Becker, SJ., Helseth, SA., Janssen, T., et al.[2022]

In a study of 204 juvenile male sexual offenders, lower levels of denial at intake were linked to better compliance with community-based treatment programs, suggesting that acknowledging issues may enhance treatment outcomes.

Despite a high program attrition rate of 50% in the first year, only a small percentage of youths were expelled for delinquency, indicating that non-compliance with attendance and therapeutic directives was a major factor in program failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with treatment compliance in a population of juvenile sexual offenders. Hunter, JA., Figueredo, AJ.[2017]

The Connecting program, a self-directed substance-use prevention initiative for foster families, showed that 60% of participants were 'very satisfied' and 85% would recommend it, indicating high acceptability among caregivers.

Foster youth who participated in the program reported significant improvements in problem-solving skills and involvement in family rule-making, suggesting that the program effectively enhances certain protective factors against substance use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proximal Outcomes of Connecting, an Evidence-based, Family-focused Prevention Program for Caregivers of Adolescents in Foster Care. Haggerty, KP., Barkan, SE., Skinner, ML., et al.[2022]

The Child and Adolescent Symptom Inventory (CASI) Substance Use subscale effectively distinguishes between adolescents and young adults with and without substance use disorders (SUDs), showing high diagnostic accuracy with an area under the curve (AUC) of 0.91 for caregiver reports and 0.90 for self-reports.

With a sample size of 479 outpatient youth aged 14-21, the study supports the clinical utility of the CASI-4R subscale as a reliable screening tool for identifying SUDs in mental health settings, indicating its potential for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of the Child and Adolescent Symptom Inventory (CASI-4R) substance use subscale in detecting substance use disorders in youth. Tsai, AP., Youngstrom, EA., Gadow, KD., et al.[2023]

The study involved 489 early adolescents from 41 community-based agencies in New York City, who participated in a randomized trial using a skills-based interactive CD-ROM for alcohol abuse prevention.

Participants who used the CD-ROM showed increased awareness of the harms of alcohol and improved assertiveness skills, indicating that this technology can effectively engage high-risk youth, although actual drinking rates remained unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol abuse prevention among high-risk youth: computer-based intervention. Schinke, SP., Schwinn, TM., Ozanian, AJ.[2023]

Adolescent substance use can lead to serious long-term issues such as dependence, criminal behavior, and mental health disorders, highlighting the need for effective family-based interventions.

The article reviews various evidence-based family treatments for adolescent substance use, including multisystemic therapy and functional family therapy, emphasizing their outcomes and implementation factors to help clinicians choose the best approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Based Treatments for Adolescent Substance Use. Horigian, VE., Anderson, AR., Szapocznik, J.[2020]

Citations

1. researchgate.net researchgate.net/figure/Boosting-Violence-Related-Outcomes-Using-Technology-for-Empowerment-Risk-Reduction-and_fig1_370441179

Boosting Violence-Related Outcomes Using Technology ... Boosting Violence-Related Outcomes Using Technology for Empowerment, Risk Reduction, and Life Skills Preparation in Youth Based on Acceptance and Commitment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10186193/

A Technology-Enhanced Intervention for Violence and ... This study aimed to systematically adapt and pilot-test Boosting Violence-Related Outcomes Using Technology for Empowerment, Risk Reduction, and Life Skills ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06359990

BrotherlyACT: A Tech-Enhanced Violence and Substance ... 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 ...

4. withpower.com withpower.com/trial/phase-substance-related-disorders-1-2024-20278

BrotherlyACT for Youth Violence and Substance Use BrotherlyACT is unique because it combines technology with Acceptance and Commitment Therapy (ACT) to empower youth, reduce risks, and build life skills ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37126388/

Protocol for Adaptation and Pilot Testing The study aims to systematically adapt and pilot-test Boosting Violence-Related Outcomes Using Technology for Empowerment, Risk Reduction, and Life Skills ...

6. researchgate.net researchgate.net/figure/Boosting-Violence-Related-Outcomes-Using-Technology-for-Empowerment-Risk-Reduction-and_fig1_367641703

Boosting Violence-Related Outcomes Using Technology ... Objective This pilot study aims to evaluate the preliminary effects of BrotherlyACT, a culturally responsive, trauma-informed, multicomponent mobile and web- ...