Firearm ViolenceNCT05109325
Project IntERact V2
A study testing IntERact in people with Firearm Violence and Firearm Carriage, run by University of Michigan at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Firearm Violence, Firearm Carriage, Injury Prevention
- What is being tested?
- IntERact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jan 2022to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Flint or Saginaw Youth between the ages of 16 to 30 reporting past 3-month firearm carriage and ownership of a smartphone, including those seeking care for any reason at Hurley Medical Center or Covenant Medical Center Emergency Department.
- Can provide consent (age: 18-30) or youth assent and parental consent (age: 16-17) for the study.
Who cannot join
- Incarcerated (i.e., in active policy custody and not able to provide informed consent)
- Presenting to the ED for active suicide ideation or attempt, sexual assault, and/or child abuse
- Unable to provide informed consent due to mental status (e.g., alcohol intoxication, acute psychosis) or medical instability.
- Participants will be excluded if firearm carriage is exclusively for legal work (e.g., police), hunting, or target shooting.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Hurley Medical Center
Flint, Michigan, 48503
Covenant Medical Center
Saginaw, Michigan, 48602
About this study
Official title: IntERact: Preventing Risky Firearm Behaviors Among Urban Youth Seeking Emergency Department Care
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.
Read the detailed description
Firearms are the leading cause of death for U.S. youth; 60% due to homicide. This study will test the efficacy of a behavioral intervention at reducing risky firearm behaviors among a high-risk community sample of youth (age 16-24) that report past 3-month firearm carriage and smartphone ownership. The behavioral intervention consists of 3 remotely delivered therapy sessions integrating motivational interviewing (MI), cognitive behavioral therapy (CBT), and care management (CM), supported by a smartphone APP that facilitates therapist contact, conducts automated daily assessments, delivers between session tailored therapy content, delivers just-in-time Global Positioning System (GPS)-triggered notifications upon entry into high-risk locations, and aids with utilization of local resources. Recruitment will proceed in two high-risk communities (Flint, Saginaw), including through the main Emergency Departments/trauma centers that are located in both cities. Given elevated rates of firearm violence among socio-disadvantaged youth with disparities in access to community services, the proposed intervention, if found to be efficacious, has the potential for significant public health impact.
- Conditions
- Firearm Violence, Firearm Carriage, Injury Prevention
- Being tested
- IntERact
- Keywords
- Emergency Department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntERactBehavioural
The IntERact intervention includes: (1) three remotely delivered Health Coach therapist sessions that integrate behavioral therapy (motivational interviewing [MI] + cognitive behavioral therapy [CBT] and strengths-based care management (CM); as well as, (2) an APP supporting and enhancing the therapist intervention by: (a) conducting automated daily assessments; (b) delivering daily MI/CBT messages tailored by the daily surveys; (c) delivering GPS-enabled alert notifications and immediate one-touch pro-social support; (d) providing access to reminders regarding goals/strengths from the ED session, CBT tools/skills (e.g., infographics, coping strategies, harm reduction strategies), and other psychoeducation (e.g., safe storage); (e) facilitating one-touch contact with pro-social support, including the health coach and others; (f) providing easy linkage to care management resources (web links, phone numbers, contact information).
| Study group | Role | What they receive |
|---|---|---|
| Enhanced usual care + assessment | No 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 | Experimental | 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. Receives: Behavioral: IntERact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Risky Firearm Behaviors
Composite measure used in prior work (Carter 2019). Composite measure uses items from the Tulane University Youth Study and Conflict Tactics Scale capturing frequency and severity of risky firearm-related behaviors (e.g. carriage, threats, use, etc.). (0=Never; 6=20+ Times)
Measured: Baseline to 3 months and 6 months
Secondary outcomes (2)
Change in Aggression
Aggression will be measured at Baseline, 3 months, 6 months. Conflict Tactic Scale measures have been used in prior work and is scored using a summary scale. (0=Never; 6=20+ Times).
Measured: Baseline to 3 months and 6 months
Change in Victimization
Victimization will be measured at Baseline, 3 months, 6 months. Conflict Tactic Scale measures have been used in prior work and is scored using summary scale (0=Never; 6=20+ Times).
Measured: Baseline to 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start24 Jan 2022
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Firearm ViolenceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Patrick Carter, University of Michigan
- Investigators
- Patrick Carter, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109325
- Sponsor's protocol ID
- HUM00188022
- Other IDs
- R01CE003303
- Status last verified
- Apr 2026
- First submitted
- 26 Oct 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carter PM, Resnicow K, Stallworth P, Goldstick J, Carrillo A, Seewald L, Cunningham RM, Massey L, Battisti K, Schoener B, Walton MA. Efficacy of Technology-Augmented Behavioral Counseling for Risky Firearm Behaviors: A Randomized Clinical Trial. JAMA Pediatr. 2026 Sep 28. doi: 10.1001/jamapediatrics.2026.3893. Online ahead of print.
PubMed 42804194
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IntERact: Preventing Risky Firearm Behaviors Among Urban Youth Seeking Emergency Department Care
- ClinicalTrials.gov ID
- NCT05109325
- Acronym / sponsor ID
- HUM00188022
- Conditions
- Firearm Violence, Firearm Carriage, Injury Prevention
- Keywords
- Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Firearms are the leading cause of death for U.S. youth; 60% due to homicide. This study will test the efficacy of a behavioral intervention at reducing risky firearm behaviors among a high-risk community sample of youth (age 16-24) that report past 3-month firearm carriage and smartphone ownership. The behavioral intervention consists of 3 remotely delivered therapy sessions integrating motivational interviewing (MI), cognitive behavioral therapy (CBT), and care management (CM), supported by a smartphone APP that facilitates therapist contact, conducts automated daily assessments, delivers between session tailored therapy content, delivers just-in-time Global Positioning System (GPS)-triggered notifications upon entry into high-risk locations, and aids with utilization of local resources. Recruitment will proceed in two high-risk communities (Flint, Saginaw), including through the main Emergency Departments/trauma centers that are located in both cities. Given elevated rates of firearm violence among socio-disadvantaged youth with disparities in access to community services, the proposed intervention, if found to be efficacious, has the potential for significant public health impact.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care + assessment | No 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 | Experimental | Behavioral: IntERactParticipants 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. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Flint or Saginaw Youth between the ages of 16 to 30 reporting past 3-month firearm carriage and ownership of a smartphone, including those seeking care for any reason at Hurley Medical Center or Covenant Medical Center Emergency Department.
- Can provide consent (age: 18-30) or youth assent and parental consent (age: 16-17) for the study.
Key exclusion criteria (4 listed)
- Incarcerated (i.e., in active policy custody and not able to provide informed consent)
- Presenting to the ED for active suicide ideation or attempt, sexual assault, and/or child abuse
- Unable to provide informed consent due to mental status (e.g., alcohol intoxication, acute psychosis) or medical instability.
- Participants will be excluded if firearm carriage is exclusively for legal work (e.g., police), hunting, or target shooting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntERactThe IntERact intervention includes: (1) three remotely delivered Health Coach therapist sessions that integrate behavioral therapy (motivational interviewing [MI] + cognitive behavioral therapy [CBT] and strengths-based care management (CM); as well as, (2) an APP supporting and enhancing the therapist intervention by: (a) conducting automated daily assessments; (b) delivering daily MI/CBT messages tailored by the daily surveys; (c) delivering GPS-enabled alert notifications and immediate one-touch pro-social support; (d) providing access to reminders regarding goals/strengths from the ED session, CBT tools/skills (e.g., infographics, coping strategies, harm reduction strategies), and other psychoeducation (e.g., safe storage); (e) facilitating one-touch contact with pro-social support, including the health coach and others; (f) providing easy linkage to care management resources (web links, phone numbers, contact information). | Behavioural | IntERact |
Primary outcome
Change in Risky Firearm Behaviors
Time frame: Baseline to 3 months and 6 months
Composite measure used in prior work (Carter 2019). Composite measure uses items from the Tulane University Youth Study and Conflict Tactics Scale capturing frequency and severity of risky firearm-related behaviors (e.g. carriage, threats, use, etc.). (0=Never; 6=20+ Times)
2 secondary outcomes
Change in Aggression
Time frame: Baseline to 3 months and 6 months
Change in Victimization
Time frame: Baseline to 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 42804194Carter PM, Resnicow K, Stallworth P, Goldstick J, Carrillo A, Seewald L, Cunningham RM, Massey L, Battisti K, Schoener B, Walton MA. Efficacy of Technology-Augmented Behavioral Counseling for Risky Firearm Behaviors: A Randomized Clinical Trial. JAMA Pediatr. 2026 Sep 28. doi: 10.1001/jamapediatrics.2026.3893. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Carter, M.D. principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IntERact in people with Firearm Violence and Firearm Carriage, run by University of Michigan at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Risky Firearm Behaviors (time frame: Baseline to 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05109325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.