NCT04622943

Brief 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 â…“ 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

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

First Submitted

Initial submission to the registry

October 26, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 14, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 10, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

October 26, 2020

Results QC Date

February 20, 2025

Last Update Submit

March 7, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of Knowledge Items Answered Correctly

    firearms safety knowledge scale (10 items, minimum value 0 and maximum value 10). Higher scores indicate greater knowledge.

    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

    1 week after intervention completed

Study Arms (2)

firearms safety

EXPERIMENTAL

Children will spend two 45-minute sessions engaged on ShootSafe, an internet-based training program on firearms safety.

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.

Behavioral: nutrition

Interventions

firearms safetyBEHAVIORAL

interactive and engaging website with videos and educational games to teach children firearms, hunting and shooting safety

firearms safety
nutritionBEHAVIORAL

interactive and engaging website with videos and educational games to teach children about nutrition and wellbeing

nutrition

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • disabilities that prohibit participants from valid understanding of or participation in the experimental protocol
  • siblings of enrolled child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Youth Safety Lab, University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

  • 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.

  • Schwebel 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.

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Results Point of Contact

Title
Dr. David Schwebel
Organization
University of Alabama at Birmingham

Study Officials

  • David Schwebel, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Professor of Psychology & Associate Vice President for Research Facilities & Infrastructure

Study Record Dates

First Submitted

October 26, 2020

First Posted

November 10, 2020

Study Start

December 14, 2021

Primary Completion

May 10, 2024

Study Completion

May 10, 2024

Last Updated

March 18, 2025

Results First Posted

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

De-identified data will be shared with qualified parties upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
after all primary analyses are conducted and published, for 3 year period
Access Criteria
qualified user with appropriate training and approval

Locations