IntERact Behavior Intervention for Firearm Carrying

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new behavioral program called IntERact to determine its effectiveness in reducing risky firearm carrying among young people. Participants will either receive standard care with resources or engage in three remote therapy sessions and use a supporting smartphone app. The trial seeks youth aged 16 to 30 from Flint or Saginaw who have carried a firearm in the past three months and own a smartphone. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to safer communities.

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 IntERact Behavioral Intervention is safe?

Research shows that the IntERact program aims to help young people reduce risky behavior with firearms. This program uses methods like motivational interviewing and cognitive behavioral skills training, which most participants find manageable.

Past studies have shown no safety issues with this program. Since it doesn't involve medications, the chance of physical side effects remains very low. Instead, it helps change behavior and thought patterns through conversation and support.

The trial is in a "Not Applicable" phase, indicating it doesn't involve testing a new drug or medical device. This phase usually focuses on the program's effectiveness rather than safety concerns.

Overall, participants can expect a safe experience, as the program includes remote therapy sessions and app content, both of which are non-invasive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IntERact program because it offers a fresh approach to reducing firearm carrying among young people. Unlike traditional methods that might focus solely on punishment or counseling, IntERact combines motivational interviewing, cognitive behavioral skills training, and care management. This innovative approach is delivered remotely, making it more accessible, and is supported by a smartphone app that provides ongoing therapeutic content. These features not only enhance engagement but could potentially lead to more effective and lasting behavior change.

What evidence suggests that the IntERact Behavioral Intervention is effective for reducing risky firearm carriage among youth?

Research has shown that the IntERact program, which participants in this trial may receive, might help reduce risky gun carrying among high-risk youth. This program uses motivational talks, training in thinking and behavior skills, and support from care managers. These methods have proven effective in helping people make better decisions and manage stress. Early results suggest that similar programs can lead to fewer emergency room visits for violent injuries, reduced drug and alcohol use, and improved mental health. Although this study is ongoing, the IntERact program is based on techniques that have succeeded in other programs. ^{1 2 3 5 6}

Who Is on the Research Team?

Patrick Carter, M.D.

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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, 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]

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]

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 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 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]

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]

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]

Citations

1. firearminjury.umich.edu firearminjury.umich.edu/project/interact-preventing-risky-firearm-behaviors-among-urban-youth-seeking-emergency-department-care-project-interact-v2/

Preventing Risky Firearm Behaviors Among Urban Youth ... Secondary Outcomes include: (1) ED visits for violent injury (e.g., firearm injuries); (2) substance use; (3) mental health symptoms (i.e., anxiety, depression, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05109325

Study Details | NCT05109325 | Project IntERact V2 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 ...

3. withpower.com withpower.com/trial/phase-10-2021-52aff

IntERact Behavior Intervention for Firearm Carrying 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 ...

4. cdc.gov cdc.gov/firearm-violence/php/funded-research/current-three-year-awardees-rfa-ce-20-006.html

RFA-CE-20-006: 3-year awards | Firearm Injury and Death ... This study will determine the effectiveness of IntERact, a technology-enhanced behavioral intervention, in reducing risky firearm behaviors, ...

5. reporter.nih.gov reporter.nih.gov/project-details/10900436

Project Details - NIH RePORTER The objective of our proposal is to improve the evidence base for youth firearm prevention by conducting a comprehensive multilevel evaluation with the use of ...

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05109325?keyword=%22Firearm%20Violence%22

San Mateo Clinical Trial Project IntERact V2 The present study is evaluating the efficacy of a behavioral intervention to reduce risky firearm carriage among a high risk sample of youth reporting ...