Firearm InjurySEEDNCT05168878
Safety Education in the Emergency Department: A Pilot Study
A study testing 30-second BeSMART video and 3-minute BeSMART video in people with Firearm Injury, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this pilot study is to assess the feasibility and acceptability of video-based safe firearm storage education in the Pediatric Emergency Department. Read more about this study
- Who is it for?
- Ages 30 days to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Firearm Injury
- What is being tested?
- 30-second BeSMART video and 3-minute BeSMART video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2020to 1 Dec 2022
- 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 30 days to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children > 30 days and < 18 years old presenting to the CHCO ED
- Parent/guardian who is ≥ 18 and ≤ 85 years old
- Arms 1 \& 2 will include a subset of patients ≥10 years and < 18 years old with a firearm in the home.
Who cannot join
- Child is in an emergent/acute medical condition
- Patient seen in our fast track area or other room without a television
- Parent/guardian is non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Safety Education in the Emergency Department (SEED): A Pilot Study
The purpose of this pilot study is to assess the feasibility and acceptability of video-based safe firearm storage education in the Pediatric Emergency Department.
- Conditions
- Firearm Injury
- Being tested
- 30-second BeSMART video, 3-minute BeSMART video
- Keywords
- Injury prevention, anticipatory guidance, firearm counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30-second BeSMART videoBehavioural
30 second video focused on education about child gun deaths and responsible gun storage
3-minute BeSMART videoBehavioural
3-minute video focused on education about child gun deaths and responsible gun storage
| Study group | Role | What they receive |
|---|---|---|
| Patient > 9 yo, no video | No intervention | Caregivers of patients greater than or equal to 10 years old will not be shown a video in the PED. |
| Patient > 9 yo, 3 minute video | Active comparator | Caregivers of patients greater than or equal to 10 years old will be shown a 3-minute BeSMART video in the PED. Receives: Behavioral: 3-minute BeSMART video |
| Any age, 30-second video | Experimental | Caregivers of patients of any age will be shown a 30 second BeSMART video in the PED. Receives: Behavioral: 30-second BeSMART video |
| Any age, 3 minute video | Experimental | Caregivers of patients of any age will be shown a 3-minute BeSMART video in the PED. Receives: Behavioral: 3-minute BeSMART video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention
Acceptability of the educational videos measured using agreement with the question, "Overall I liked the video". Responses will be on a Likert scale with 1 being the lowest and 5 being the highest.
Measured: At baseline
Feasibility of Follow up
Feasibility of completing a follow up survey with parents within 3 months after the intervention measured by the proportion of caregivers who complete the survey in its entirety either electronically or by phone.
Measured: Through study completion, an average of three months
Safe Firearm Storage
Self- report based on the survey question, "Are any of the guns in your home kept unlocked?" at baseline. This question has a yes/ no answer.
Measured: At baseline
Safe Firearm Storage at Three Months
Self- report at two time points based on the survey question, "Are any of the guns in your home kept unlocked?" at three month follow up; yes/ no answer.
Measured: Three month follow up
Knowledge About Temporary Firearm Transfer at Baseline
Parental awareness of temporary firearm transfer will be measured by self-report based on question, "Did you know that you can temporarily take your guns out of your home if you are concerned that someone in your house may hurt themselves or someone else?". (responses answers are yes or no) OR ability to name at least one location for temporary firearm storage OR describe the link for a map of storage locations.
Measured: At baseline
Knowledge About Temporary Firearm Transfer at Follow up
Parental awareness of temporary firearm transfer will be measured by self-report based on question, "Did you know that you can temporarily take your guns out of your home if you are concerned that someone in your house may hurt themselves or someone else?". (responses answers are yes or no) and ability to name at least one location for temporary firearm storage OR describe the link for a map of storage locations.
Measured: At study follow-up, an average of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start19 Aug 2020
- Primary completion1 Sep 2022
- Study completion1 Dec 2022
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 (1)Papers the sponsor has linked to this study.
- Other trials for Firearm InjuryStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- None (open label)
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute, Emergency Medicine Foundation, American Foundation for Firearm Injury Reduction in Medicine
- Responsible party
- Sponsor
- Investigators
- Maya Haasz, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168878
- Sponsor's protocol ID
- 20-0238
- Other IDs
- CMH-M-20-15
- Acronym
- SEED
- Status last verified
- Aug 2024
- First submitted
- 23 Nov 2021
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haasz M, Betz ME, Ambroggio L, Cafferty R, King CA, Wong S, Leonard J, Brooks-Russell A, Sigel E. Acceptability and feasibility of video-based firearm safety education in a Colorado emergency department for caregivers of adolescents in firearm-owning households. Inj Prev. 2026 Jan 20;32(1):90-97. doi: 10.1136/ip-2023-045204.
PubMed 39053924
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Education in the Emergency Department (SEED): A Pilot Study
- ClinicalTrials.gov ID
- NCT05168878
- Acronym / sponsor ID
- SEED / 20-0238
- Conditions
- Firearm Injury
- Keywords
- Injury prevention, anticipatory guidance, firearm counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute, Emergency Medicine Foundation, American Foundation for Firearm Injury Reduction in Medicine
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to assess the feasibility and acceptability of video-based safe firearm storage education in the Pediatric Emergency Department.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient > 9 yo, no video | No intervention | –Caregivers of patients greater than or equal to 10 years old will not be shown a video in the PED. |
| Patient > 9 yo, 3 minute video | Active comparator | Behavioral: 3-minute BeSMART videoCaregivers of patients greater than or equal to 10 years old will be shown a 3-minute BeSMART video in the PED. |
| Any age, 30-second video | Experimental | Behavioral: 30-second BeSMART videoCaregivers of patients of any age will be shown a 30 second BeSMART video in the PED. |
| Any age, 3 minute video | Experimental | Behavioral: 3-minute BeSMART videoCaregivers of patients of any age will be shown a 3-minute BeSMART video in the PED. |
Who may qualify
- Ages
- 30 days to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children > 30 days and < 18 years old presenting to the CHCO ED
- Parent/guardian who is ≥ 18 and ≤ 85 years old
- Arms 1 \& 2 will include a subset of patients ≥10 years and < 18 years old with a firearm in the home.
Key exclusion criteria (3 listed)
- Child is in an emergent/acute medical condition
- Patient seen in our fast track area or other room without a television
- Parent/guardian is non-English speaking.
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 |
|---|---|---|
| 30-second BeSMART video30 second video focused on education about child gun deaths and responsible gun storage | Behavioural | Any age, 30-second video |
| 3-minute BeSMART video3-minute video focused on education about child gun deaths and responsible gun storage | Behavioural | Any age, 3 minute video, Patient > 9 yo, 3 minute video |
Primary outcome
Acceptability of Intervention
Time frame: At baseline
Acceptability of the educational videos measured using agreement with the question, "Overall I liked the video". Responses will be on a Likert scale with 1 being the lowest and 5 being the highest.
Feasibility of Follow up
Time frame: Through study completion, an average of three months
Feasibility of completing a follow up survey with parents within 3 months after the intervention measured by the proportion of caregivers who complete the survey in its entirety either electronically or by phone.
Safe Firearm Storage
Time frame: At baseline
Self- report based on the survey question, "Are any of the guns in your home kept unlocked?" at baseline. This question has a yes/ no answer.
Safe Firearm Storage at Three Months
Time frame: Three month follow up
Self- report at two time points based on the survey question, "Are any of the guns in your home kept unlocked?" at three month follow up; yes/ no answer.
Knowledge About Temporary Firearm Transfer at Baseline
Time frame: At baseline
Parental awareness of temporary firearm transfer will be measured by self-report based on question, "Did you know that you can temporarily take your guns out of your home if you are concerned that someone in your house may hurt themselves or someone else?". (responses answers are yes or no) OR ability to name at least one location for temporary firearm storage OR describe the link for a map of storage locations.
Knowledge About Temporary Firearm Transfer at Follow up
Time frame: At study follow-up, an average of three months
Parental awareness of temporary firearm transfer will be measured by self-report based on question, "Did you know that you can temporarily take your guns out of your home if you are concerned that someone in your house may hurt themselves or someone else?". (responses answers are yes or no) and ability to name at least one location for temporary firearm storage OR describe the link for a map of storage locations.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39053924Haasz M, Betz ME, Ambroggio L, Cafferty R, King CA, Wong S, Leonard J, Brooks-Russell A, Sigel E. Acceptability and feasibility of video-based firearm safety education in a Colorado emergency department for caregivers of adolescents in firearm-owning households. Inj Prev. 2026 Jan 20;32(1):90-97. doi: 10.1136/ip-2023-045204.
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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.
Maya Haasz, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30-second BeSMART video and 3-minute BeSMART video in people with Firearm Injury, run by University of Colorado, Denver 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 3 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 17 Oct 2024. 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 17 Oct 2024). 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?
Acceptability of Intervention (time frame: At baseline). The study lists 6 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 NCT05168878, 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 17 Oct 2024.