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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment BrotherlyACT for youth violence and substance use?

Research on similar treatments, like Integrated Family and Cognitive-Behavioral Therapy (IFCBT), shows significant reductions in substance use among adolescents, suggesting that family-based and cognitive-behavioral approaches can be effective. Additionally, technology-assisted interventions like Parent SMART have shown promise in engaging parents and reducing substance use in adolescents, indicating that combining technology with therapy may enhance outcomes. ^{1 2 3 4 5}

Is BrotherlyACT safe for humans?

The research on Integrated Family and Cognitive-Behavioral Therapy (IFCBT), which may be similar to BrotherlyACT, found no harmful effects in youth participants, suggesting it is generally safe for humans. ^{2 3 4 6 7}

How is the BrotherlyACT treatment different from other treatments 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, which is different from traditional therapies that may not integrate technology or focus on these specific areas. ^{3 4 6 8 9}

Research Team

Chuka N Emezue, PhD, MPH

Principal Investigator

Rush University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Family-Based Treatments for Adolescent Substance Use. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Parent SMART (Substance Misuse in Adolescents in Residential Treatment): Pilot randomized trial of a technology-assisted parenting intervention. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Integrated family and cognitive-behavioral therapy for adolescent substance abusers: a stage I efficacy study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Intervention for marijuana using, court-involved non-incarcerated youth. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Factors associated with treatment compliance in a population of juvenile sexual offenders. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Proximal Outcomes of Connecting, an Evidence-based, Family-focused Prevention Program for Caregivers of Adolescents in Foster Care. [2022]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Multidimensional Family Therapy for Justice-Involved Young Adults with Substance Use Disorders. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Alcohol abuse prevention among high-risk youth: computer-based intervention. [2023]