NCT05168878

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
407

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 17, 2024

Completed
Last Updated

October 17, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

November 23, 2021

Results QC Date

January 25, 2024

Last Update Submit

August 1, 2024

Conditions

Keywords

Injury preventionanticipatory guidancefirearm counseling

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    At study follow-up, an average of three months

Study Arms (4)

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.

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.

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.

Behavioral: 3-minute BeSMART video

Interventions

30 second video focused on education about child gun deaths and responsible gun storage

Any age, 30-second video

3-minute video focused on education about child gun deaths and responsible gun storage

Any age, 3 minute videoPatient > 9 yo, 3 minute video

Eligibility Criteria

Age30 Days - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • 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. 2024 Jul 24:ip-2023-045204. doi: 10.1136/ip-2023-045204. Online ahead of print.

Results Point of Contact

Title
Dr. Maya Haasz
Organization
University of Colorado

Study Officials

  • Maya Haasz, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2021

First Posted

December 23, 2021

Study Start

August 19, 2020

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

October 17, 2024

Results First Posted

October 17, 2024

Record last verified: 2024-08

Locations