Safety IssuesNCT04622943
An Interactive Web Platform to Teach Children Hunting, Shooting and Firearms Safety
A study testing firearms safety and nutrition in people with Safety Issues and Injuries, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Firearms injuries present a major pediatric public health challenge, killing >800 children ages 0-15 annually and leading to lifelong disability among >1000 survivors. About ⅓ of firearms injuries to children under age 15 are due to unintentional causes rather than suicide or homicide. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Injuries, Firearm Injury
- What is being tested?
- firearms safety and nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 10 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children ages 10-12 years
- English-speaking child and parent
- Experience or exposure to firearms in their homes or through engagement in hunting or shooting
Who cannot join
- disabilities that prohibit participants from valid understanding of or participation in the experimental protocol
- siblings of enrolled child
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Youth Safety Lab, University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: ShootSafe: An Interactive Web Platform to Teach Children Hunting, Shooting and Firearms Safety
Firearms injuries present a major pediatric public health challenge, killing >800 children ages 0-15 annually and leading to lifelong disability among >1000 survivors. About ⅓ of firearms injuries to children under age 15 are due to unintentional causes rather than suicide or homicide. The investigators propose development and evaluation of ShootSafe, an innovative, engaging, and educational website accessible by smartphone, tablet or computer that engages children to learn firearms safety.
ShootSafe extends existing programs to achieve 3 primary goals: a) teach children knowledge and skills they need to hunt, shoot, and use firearms safely; b) help children learn and hone critical cognitive skills of impulse control and hypothetical thinking needed to use firearms safely; and c) alter children's perceptions about their own vulnerability and susceptibility to firearms-related injuries, the severity of those injuries, and their perceived norms about peer behavior surrounding firearms use. ShootSafe will accomplish these goals through a combination of interactive games plus podcast videos delivered by peer actors (impactful testimonials about firearms injuries/deaths they experienced) and experts (wisdom \& experience from trusted role models). The website will also incorporate brief messaging to parents, who will absorb key lessons and reinforce them with their children.
The website will be evaluated through a randomized controlled trial with 162 children ages 10-12, randomly assigning children to engage in the ShootSafe website or an active control website on child nutrition. The investigators will incorporate sub-aims to evaluate changes in children's (a) knowledge, (b) cognitive skills in impulse control and hypothetical thinking, (c) perceptions about firearms safety, and (d) simulated behavior when handling, storing and transporting firearms. All outcome measures will be assessed at baseline, immediately post-intervention, and at a 4-month follow-up assessment to evaluate retention. Training will comprise two 30-minute sessions.
- Conditions
- Safety Issues, Injuries, Firearm Injury
- Being tested
- firearms safety, nutrition
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
firearms safetyBehavioural
interactive and engaging website with videos and educational games to teach children firearms, hunting and shooting safety
nutritionBehavioural
interactive and engaging website with videos and educational games to teach children about nutrition and wellbeing
| Study group | Role | What they receive |
|---|---|---|
| firearms safety | Experimental | Children will spend two 45-minute sessions engaged on ShootSafe, an internet-based training program on firearms safety. Receives: Behavioral: firearms safety |
| nutrition | Active comparator | Children will spend two 45-minute sessions engaged in vHappy, an internet-based training program on nutrition and wellbeing. Receives: Behavioral: nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Knowledge Items Answered Correctly
firearms safety knowledge scale (10 items, minimum value 0 and maximum value 10). Higher scores indicate greater knowledge.
Measured: 1 week after intervention completed
Risky Behavior in Simulated Hunting Scenario
Number of simulated situations when it was dangerous to shoot the toy firearm and the child took shots
Measured: 1 week after intervention completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start14 Dec 2021
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Schwebel, University of Alabama at Birmingham
- Investigators
- David Schwebel, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622943
- Sponsor's protocol ID
- R01CE003307
- Status last verified
- Mar 2025
- First submitted
- 26 Oct 2020
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with qualified parties upon request.
Publications
Schwebel DC, Long DL, Johnston A, He Y, Morgan CH, Severson J, Taylor G, Trullinger K. Evaluation of ShootSafe, an Interactive, Sequential Website to Teach Youths Firearms Safety: A Randomized Clinical Trial. Am J Public Health. 2025 Dec;115(12):1971-1977. doi: 10.2105/AJPH.2025.308267. Epub 2025 Sep 18.
PubMed 40966575Schwebel DC, Long DL, Gowey M, Severson J, He Y, Trullinger K. Study protocol: developing and evaluating an interactive web platform to teach children hunting, shooting and firearms safety: a randomized controlled trial. BMC Public Health. 2021 Feb 6;21(1):308. doi: 10.1186/s12889-021-10345-3.
PubMed 33549072
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ShootSafe: An Interactive Web Platform to Teach Children Hunting, Shooting and Firearms Safety
- ClinicalTrials.gov ID
- NCT04622943
- Acronym / sponsor ID
- R01CE003307
- Conditions
- Safety Issues, Injuries, Firearm Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Posted 10 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Firearms injuries present a major pediatric public health challenge, killing >800 children ages 0-15 annually and leading to lifelong disability among >1000 survivors. About ⅓ of firearms injuries to children under age 15 are due to unintentional causes rather than suicide or homicide. The investigators propose development and evaluation of ShootSafe, an innovative, engaging, and educational website accessible by smartphone, tablet or computer that engages children to learn firearms safety.
ShootSafe extends existing programs to achieve 3 primary goals: a) teach children knowledge and skills they need to hunt, shoot, and use firearms safely; b) help children learn and hone critical cognitive skills of impulse control and hypothetical thinking needed to use firearms safely; and c) alter children's perceptions about their own vulnerability and susceptibility to firearms-related injuries, the severity of those injuries, and their perceived norms about peer behavior surrounding firearms use. ShootSafe will accomplish these goals through a combination of interactive games plus podcast videos delivered by peer actors (impactful testimonials about firearms injuries/deaths they experienced) and experts (wisdom \& experience from trusted role models). The website will also incorporate brief messaging to parents, who will absorb key lessons and reinforce them with their children.
The website will be evaluated through a randomized controlled trial with 162 children ages 10-12, randomly assigning children to engage in the ShootSafe website or an active control website on child nutrition. The investigators will incorporate sub-aims to evaluate changes in children's (a) knowledge, (b) cognitive skills in impulse control and hypothetical thinking, (c) perceptions about firearms safety, and (d) simulated behavior when handling, storing and transporting firearms. All outcome measures will be assessed at baseline, immediately post-intervention, and at a 4-month follow-up assessment to evaluate retention. Training will comprise two 30-minute sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| firearms safety | Experimental | Behavioral: firearms safetyChildren will spend two 45-minute sessions engaged on ShootSafe, an internet-based training program on firearms safety. |
| nutrition | Active comparator | Behavioral: nutritionChildren will spend two 45-minute sessions engaged in vHappy, an internet-based training program on nutrition and wellbeing. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children ages 10-12 years
- English-speaking child and parent
- Experience or exposure to firearms in their homes or through engagement in hunting or shooting
Key exclusion criteria (2 listed)
- disabilities that prohibit participants from valid understanding of or participation in the experimental protocol
- siblings of enrolled child
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 |
|---|---|---|
| firearms safetyinteractive and engaging website with videos and educational games to teach children firearms, hunting and shooting safety | Behavioural | firearms safety |
| nutritioninteractive and engaging website with videos and educational games to teach children about nutrition and wellbeing | Behavioural | nutrition |
Primary outcome
Number of Knowledge Items Answered Correctly
Time frame: 1 week after intervention completed
firearms safety knowledge scale (10 items, minimum value 0 and maximum value 10). Higher scores indicate greater knowledge.
Risky Behavior in Simulated Hunting Scenario
Time frame: 1 week after intervention completed
Number of simulated situations when it was dangerous to shoot the toy firearm and the child took shots
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40966575Schwebel DC, Long DL, Johnston A, He Y, Morgan CH, Severson J, Taylor G, Trullinger K. Evaluation of ShootSafe, an Interactive, Sequential Website to Teach Youths Firearms Safety: A Randomized Clinical Trial. Am J Public Health. 2025 Dec;115(12):1971-1977. doi: 10.2105/AJPH.2025.308267. Epub 2025 Sep 18.
- Derived from this study: PubMed 33549072Schwebel DC, Long DL, Gowey M, Severson J, He Y, Trullinger K. Study protocol: developing and evaluating an interactive web platform to teach children hunting, shooting and firearms safety: a randomized controlled trial. BMC Public Health. 2021 Feb 6;21(1):308. doi: 10.1186/s12889-021-10345-3.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with qualified parties upon request.
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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.
David Schwebel, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing firearms safety and nutrition in people with Safety Issues and Injuries, run by University of Alabama at Birmingham 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 3 inclusion and 2 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 18 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Knowledge Items Answered Correctly (time frame: 1 week after intervention completed). 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?
On the ClinicalTrials.gov record for NCT04622943, which also lists 2 linked publications.
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 18 Mar 2025.