IntERact Behavior Intervention for Firearm Carrying

Recruiting at 2 trial locations

Overseen By Lynn Massey

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Incarceration, Suicide ideation, 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: 3

Duration: 3 months

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The present study is evaluating the efficacy of a behavioral intervention to reduce risky firearm carriage among a high risk sample of youth reporting recent firearm carriage and ownership of a smartphone.

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 IntERact Behavior Intervention for Firearm Carrying?

The 5 A's of Firearm Safety Counseling study shows that specific training can significantly improve the quality and comfort of counseling on firearm injury prevention, suggesting that structured interventions like IntERact could be effective in addressing firearm carrying behaviors. ^{1 2 3 4 5}

How is the IntERact treatment different from other treatments for firearm carrying?

The IntERact treatment is unique because it focuses on behavioral intervention to address firearm carrying, which is not typically targeted by standard medical treatments. It likely involves community education and engagement strategies, similar to programs like Ceasefire Oregon, which use education and outreach to reduce gun violence. ^{4 6 7 8 9}

Research Team

Patrick Carter, M.D.

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for Flint or Saginaw youth aged 16-24 who have carried a firearm in the past 3 months and own a smartphone. Participants must be able to consent (or provide assent with parental consent if under 18) and not be incarcerated, mentally incapacitated, or seeking emergency care for suicide, sexual assault, or child abuse.

Inclusion Criteria

I am 16-30, carried a firearm in the last 3 months, own a smartphone, and visited Hurley or Covenant Medical Center's ER.

I am between 16 and 30 years old and can give consent or have parental consent.

Exclusion Criteria

Participants will be excluded if firearm carriage is exclusively for legal work (e.g., police), hunting, or target shooting.

Unable to provide informed consent due to mental status (e.g., alcohol intoxication, acute psychosis) or medical instability

Incarcerated (i.e., in active policy custody and not able to provide informed consent)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three remotely delivered behavioral therapy sessions integrating motivational interviewing, cognitive behavioral therapy, and care management, supported by a smartphone app.

3 months

3 remote therapy sessions

Follow-up

Participants are monitored for changes in risky firearm behaviors, aggression, and victimization at 3 and 6 months post-baseline.

6 months

Treatment Details

Interventions

• IntERact

Trial Overview The study tests 'IntERact', a behavioral intervention aimed at reducing risky firearm carriage among young people. It targets those who recently reported carrying firearms and uses their smartphones as part of the intervention process.

Participant Groups

Group I: IntERact Experimental Treatment 1 Intervention

Participants will receive three remotely delivered behavioral therapy sessions (combining motivational interviewing, cognitive behavioral skills training, and care management), with an smartphone APP supporting the therapy and delivering therapeutic content in-between therapy sessions.

Group II: Enhanced usual care + assessment Active Control 1 Intervention

Daily assessments (without delivery of intervention components) will be conducted with EUC participants and they will receive a brochure with violence, substance use, and mental health resources.

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

Approved in United States as IntERact for:

• Reducing risky firearm behaviors among youth

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Findings from Research

The 5 A's of Firearm Safety Counseling significantly improved the comfort level and quality of counseling provided by clinical trainees on firearm injury prevention, with only 4% feeling uncomfortable after training compared to over 60% before.

The study involved 29 participants in a simulation-based randomized controlled trial, showing that specific training on the 5 A's led to a notable enhancement in the counseling quality compared to didactic education alone, indicating its potential as an effective tool for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 5 A's of firearm safety counseling: Validating a clinical counseling methodology for firearms in a simulation-based randomized controlled trial. Hoops, K., McCourt, A., Crifasi, CK.[2023]

The motivational interviewing intervention (MI-VoV) was developed for patients hospitalized due to violent injuries, and it showed promise in significantly increasing behaviors aimed at reducing violence risk at both 2 weeks and 6-12 weeks post-discharge, based on a sample of 71 patients.

Participants also reported significant reductions in fighting, weapon-carrying, and gun-carrying behaviors at the 6-12 week follow-up, suggesting that the intervention may effectively address specific risk factors for future violence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Interviewing for Victims of Armed Community Violence: A Nonexperimental Pilot Feasibility Study. Nanney, JT., Conrad, EJ., Reuther, ET., et al.[2022]

A 20-minute educational intervention significantly improved third-year medical students' self-efficacy and knowledge regarding firearm injury prevention (FIP) counseling immediately after the session, indicating that brief training can enhance confidence in discussing this important topic.

However, while some self-efficacy and knowledge gains were maintained after six months, the overall belief in the importance of FIP counseling and the likelihood of engaging in such conversations did not show significant improvement, suggesting that ongoing training may be necessary for lasting impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An educational intervention for medical students to improve self-efficacy in firearm injury prevention counseling. Kwong, JZ., Gray, JM., Rein, L., et al.[2022]

The Ceasefire Oregon gun turn-in program successfully surrendered 4,345 firearms from 1994 to 1999, demonstrating community engagement and sustainability through educational outreach and incentives.

Participants cited reasons for turning in guns, such as receiving gift certificates and a desire to no longer own the firearms, indicating that community programs can effectively reduce gun ownership and promote safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educating the community about violence through a gun turn-in program. Yurk, R., Jaramillo, L., Erwin, LL., et al.[2019]

Providing firearm storage devices along with training significantly improved safe storage practices among households of children with mental health complaints, with triple-safe storage (TSS) increasing from 32% to 56% in the intervention group after 7 days.

The study involved 256 participants and showed that those receiving the intervention had a much higher rate of adopting safe storage practices compared to those receiving usual care, highlighting the importance of integrating such safety measures into routine pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Firearm Safety Device Distribution Intervention on Storage Practices After an Emergent Mental Health Visit. Uspal, NG., Strelitz, B., Cappetto, K., et al.[2021]

The Interactive Systems Framework for Dissemination and Implementation (ISF) highlights the importance of three systems in overcoming barriers to effectively scaling evidence-based programs (EBPs) for public health impact.

Pennsylvania has successfully implemented a state-level Prevention Support System (PSS) that engages funders and policy-makers, using empirical evidence to enhance capacity-building and collaboration among researchers, funders, and practitioners, thereby addressing the challenges of translating EBPs into real-world public health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of a state-level prevention support system in promoting high-quality implementation and sustainability of evidence-based programs. Rhoades, BL., Bumbarger, BK., Moore, JE.[2022]

An intervention aimed at reducing children's play with firearms was ineffective, as observed in a study involving 24 pairs of preschool children who were videotaped before and after the intervention.

The study found that access to a parent's firearm was linked to increased gun play and aggressive behavior, highlighting the need for more effective strategies beyond just providing information to reduce gun-related play in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A firearm safety program for children: they just can't say no. Hardy, MS., Armstrong, FD., Martin, BL., et al.[2022]

The Interactive Systems Framework for Dissemination and Implementation, developed by the CDC and academic researchers, aims to bridge the gap between prevention research and practice by clarifying the roles of knowledge developers, practitioners, and intermediaries.

This special issue highlights various challenges in implementing prevention programs, including the need for a robust support system and the balance between maintaining program fidelity and allowing for necessary adaptations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers, practitioners, and funders: using the framework to get us on the same page. Emshoff, JG.[2019]

Members of 4-H Shooting Sports clubs perceive firearm injuries mainly as unintentional, but they recognize various risks, including suicide and violence, highlighting the need for comprehensive prevention strategies.

The study suggests that bystander intervention (BI) training could be beneficial for club members, as they feel a civic responsibility to act, but face barriers like lack of knowledge and confidence in intervening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bystander intervention to prevent firearm injury: A qualitative study of 4-H shooting sports participants. Trinka, T., Oesterle, DW., Silverman, AC., et al.[2023]

References

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

The 5 A's of firearm safety counseling: Validating a clinical counseling methodology for firearms in a simulation-based randomized controlled trial. [2023]

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

Motivational Interviewing for Victims of Armed Community Violence: A Nonexperimental Pilot Feasibility Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

An educational intervention for medical students to improve self-efficacy in firearm injury prevention counseling. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Educating the community about violence through a gun turn-in program. [2019]

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

Impact of a Firearm Safety Device Distribution Intervention on Storage Practices After an Emergent Mental Health Visit. [2021]

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

The role of a state-level prevention support system in promoting high-quality implementation and sustainability of evidence-based programs. [2022]

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

A firearm safety program for children: they just can't say no. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Researchers, practitioners, and funders: using the framework to get us on the same page. [2019]

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

Bystander intervention to prevent firearm injury: A qualitative study of 4-H shooting sports participants. [2023]