Firearm InjuryACTFASTNCT06123611
Pediatric Trauma Centers RE-AIM at Gun Safety
A study testing Adopting Comprehensive Training for FireArm Safety in Trauma centers in people with Firearm Injury and Safety Issues, run by Johns Hopkins University at 1 site in United States.
Trial summary
Universal firearm injury and violence prevention counseling of parents and patients has been recommended by multiple national organizations for over a decade, yet clinicians rarely deliver this counseling. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Firearm Injury, Safety Issues
- What is being tested?
- Adopting Comprehensive Training for FireArm Safety in Trauma centers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- live with an admitted pediatric trauma patient at a participating trauma center
- be fluent in English or Spanish
- Must be between the ages of 11-17 years
- admitted to a participating trauma inpatient service for an injury
- fluent in English or Spanish
- able to provide written assent and parent able to provide written consent
Who cannot join
- family members who do not live with the admitted pediatric trauma patient
- For youth trauma patients:
- Youth who are prisoners or in police custody
- Youth who are admitted due to suicide attempt
- Youth with acute conditions that would preclude provision of informed consent (i.e., acute psychosis, altered mental status, cognitive impairment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pediatric Trauma Centers RE-AIM at Gun Safety - Adopting Comprehensive Training for FireArm Safety in Trauma Centers
Universal firearm injury and violence prevention counseling of parents and patients has been recommended by multiple national organizations for over a decade, yet clinicians rarely deliver this counseling. Barriers to its implementation must be addressed in order to effectively deliver firearm related injury prevention efforts. This study will implement a universal firearm injury prevention initiative within a national cohort of three pediatric trauma centers. The investigator's long-term goal is to demonstrate best practices for pediatric trauma center-based firearm injury prevention strategies that promote safe storage practices and reduce firearm related injury and death. This research will test the effectiveness of a comprehensive training strategy for improving the implementation of a universal firearm injury prevention effort, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), to 1) increase the adoption, implementation and sustainability of a universal firearm injury prevention initiative within participating pediatric level 1 trauma centers; 2) increase firearm safety knowledge, attitudes and safe firearm storage practices among parents of pediatric trauma patients and youth patients treated within participating pediatric level 1 trauma centers, and 3) increase trauma center clinicians' firearm safety knowledge and confidence in delivering a firearm safety intervention.
- Conditions
- Firearm Injury, Safety Issues
- Being tested
- Adopting Comprehensive Training for FireArm Safety in Trauma centers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adopting Comprehensive Training for FireArm Safety in Trauma centersBehavioural
Firearm access screening, brief firearm safe storage intervention, and referral to community and preventive health resources
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | In the pre-implementation period, all trauma patients will receive standard routine care. Which may include some screening and counseling on gun safety. |
| ACTFAST Intervention | Experimental | During the implementation and maintenance periods, all trauma patients will receive study activities including firearm access screening, counseling on safe storage practices, and referral to safe storage and other community resources as appropriate. Receives: Behavioral: Adopting Comprehensive Training for FireArm Safety in Trauma centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of Intervention
This outcome will be measured using chart review protocols examining rates of firearm access screening, documentation of firearm safety counseling, documentation of referral to community based resources and connection to medical homes as well as patient hospitalization characteristics including admission diagnosis, injury severity and patient demographic characteristics.
Measured: 3 years
Parent firearm safety attitudes and behaviors
This outcome will be measured using parent survey and interview adapted from prior work by the study team.
Measured: 3 years
Secondary outcomes (2)
Clinician firearm safety knowledge and confidence
This outcome will be measured using clinician surveys derived from multiple sources developed through the prior work of members of the study team.
Measured: 3 years
Adolescent patient firearm safety attitudes and behaviors
Measure firearm injury prevention knowledge, attitudes and safe firearm practices of adolescent trauma patients (11-17 years) within participating pediatric level 1 trauma centers. This outcome will be measured using patient survey and interview adapted from prior work by the study team.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start25 Feb 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Firearm InjuryStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Children's Hospitals and Clinics of Minnesota, University of Utah, Rhode Island Hospital, Yale University
- Responsible party
- Sponsor
- Investigators
- Katherine Hoops, MD, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123611
- Sponsor's protocol ID
- IRB00407213
- Other IDs
- CE003620
- Acronym
- ACTFAST
- Status last verified
- Sep 2026
- First submitted
- 1 Nov 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the conclusion of the study, deidentified data will be made publicly available. Due to the sensitive nature of the topics being discussed, individual participant data will not be made available to other researchers outside of the study team.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Trauma Centers RE-AIM at Gun Safety - Adopting Comprehensive Training for FireArm Safety in Trauma Centers
- ClinicalTrials.gov ID
- NCT06123611
- Acronym / sponsor ID
- ACTFAST / IRB00407213
- Conditions
- Firearm Injury, Safety Issues
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Children's Hospitals and Clinics of Minnesota, University of Utah, Rhode Island Hospital, Yale University
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Nov 2023 (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.
Universal firearm injury and violence prevention counseling of parents and patients has been recommended by multiple national organizations for over a decade, yet clinicians rarely deliver this counseling. Barriers to its implementation must be addressed in order to effectively deliver firearm related injury prevention efforts. This study will implement a universal firearm injury prevention initiative within a national cohort of three pediatric trauma centers. The investigator's long-term goal is to demonstrate best practices for pediatric trauma center-based firearm injury prevention strategies that promote safe storage practices and reduce firearm related injury and death. This research will test the effectiveness of a comprehensive training strategy for improving the implementation of a universal firearm injury prevention effort, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), to 1) increase the adoption, implementation and sustainability of a universal firearm injury prevention initiative within participating pediatric level 1 trauma centers; 2) increase firearm safety knowledge, attitudes and safe firearm storage practices among parents of pediatric trauma patients and youth patients treated within participating pediatric level 1 trauma centers, and 3) increase trauma center clinicians' firearm safety knowledge and confidence in delivering a firearm safety intervention.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –In the pre-implementation period, all trauma patients will receive standard routine care. Which may include some screening and counseling on gun safety. |
| ACTFAST Intervention | Experimental | Behavioral: Adopting Comprehensive Training for FireArm Safety in Trauma centersDuring the implementation and maintenance periods, all trauma patients will receive study activities including firearm access screening, counseling on safe storage practices, and referral to safe storage and other community resources as appropriate. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- live with an admitted pediatric trauma patient at a participating trauma center
- be fluent in English or Spanish
- Must be between the ages of 11-17 years
- admitted to a participating trauma inpatient service for an injury
- fluent in English or Spanish
Key exclusion criteria (5 listed)
- family members who do not live with the admitted pediatric trauma patient
- Youth who are prisoners or in police custody
- Youth who are admitted due to suicide attempt
- Youth with acute conditions that would preclude provision of informed consent (i.e., acute psychosis, altered mental status, cognitive impairment)
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 |
|---|---|---|
| Adopting Comprehensive Training for FireArm Safety in Trauma centersFirearm access screening, brief firearm safe storage intervention, and referral to community and preventive health resources | Behavioural | ACTFAST Intervention |
Primary outcome
Implementation of Intervention
Time frame: 3 years
This outcome will be measured using chart review protocols examining rates of firearm access screening, documentation of firearm safety counseling, documentation of referral to community based resources and connection to medical homes as well as patient hospitalization characteristics including admission diagnosis, injury severity and patient demographic characteristics.
Parent firearm safety attitudes and behaviors
Time frame: 3 years
This outcome will be measured using parent survey and interview adapted from prior work by the study team.
2 secondary outcomes
Clinician firearm safety knowledge and confidence
Time frame: 3 years
Adolescent patient firearm safety attitudes and behaviors
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. At the conclusion of the study, deidentified data will be made publicly available. Due to the sensitive nature of the topics being discussed, individual participant data will not be made available to other researchers outside of the study team.
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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.
Katherine Hoops, MD, PhD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adopting Comprehensive Training for FireArm Safety in Trauma centers in people with Firearm Injury and Safety Issues, run by Johns Hopkins University at 1 site 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 6 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Implementation of Intervention (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2026.