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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04622943
Other study ID # R01CE003307
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 14, 2021
Est. completion date May 10, 2024

Study information

Verified date June 2024
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 163
Est. completion date May 10, 2024
Est. primary completion date May 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 12 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - disabilities that prohibit participants from valid understanding of or participation in the experimental protocol - siblings of enrolled child

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
firearms safety
interactive and engaging website with videos and educational games to teach children firearms, hunting and shooting safety
nutrition
interactive and engaging website with videos and educational games to teach children about nutrition and exercise

Locations

Country Name City State
United States UAB Youth Safety Lab, University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of knowledge items answered correctly children's knowledge about firearms safety (score on 10-item quiz, with possible range of 0-10 and 10 the best score) 1 week after intervention completed
Primary Composite of children's perceptions about firearms safety children's perceptions about firearms safety (composite of z-scores from the following self-report measures created for this study: perceived vulnerability/susceptibility, perceived severity of injury, and perceived peer norms) 1 week after intervention completed
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