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Guardians 4 Health for Firearm Injury Prevention in Youth

N/A
Recruiting
Led By Megan L Ranney, MD
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months
Awards & highlights

Study Summary

This trial will study the effectiveness of The Reframe, a bystander intervention designed to promote changes in firearm injury prevention norms, attitudes, intentions, and behaviors among a sample of 50 4-H Shooting Sports Club communities comprising both adults and youth.

Who is the study for?
This trial is for youth members of local 4-H Shooting Sports Clubs, their parents, and community members. Participants must be able to speak English and give consent or assent to join the study.Check my eligibility
What is being tested?
The trial tests 'Guardians 4 Health', a program aiming to change norms, attitudes, intentions, and behaviors around firearm injury prevention among up to 60 communities involved in youth shooting sports.See study design
What are the potential side effects?
Since this intervention involves educational and behavioral strategies rather than medical treatments, traditional physical side effects are not applicable. However, participants may experience changes in their views on firearm safety.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Attitudes via Adapted Theory of Planned Behavior Scale
Change in Intention to Use Behavioral Intervention Skills via Cook-Craig et al 2014
Change in Knowledge of Firearm Injuries in the US
+2 more
Secondary outcome measures
Acceptability of Intervention via The Ottawa Acceptability Scale
Barriers to Intervention via Qualitative Interviews Using the Consolidated Framework for Intervention Research
Facilitators of Intervention via Qualitative Interviews Using the Consolidated Framework for Intervention Research
+1 more
Other outcome measures
Change in Use of Behavioral Intervention Skills via Cook-Craig et al 2014

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Up to 30 Randomized 4-H Shooting Sport Clubs that will receive Guardians 4 Health intervention.
Group II: Control GroupActive Control1 Intervention
Up to 30 4-H Shooting Sport Clubs that will not receive Guardians 4 Health intervention.

Find a Location

Who is running the clinical trial?

Brown UniversityOTHER
456 Previous Clinical Trials
557,581 Total Patients Enrolled
Rhode Island HospitalLead Sponsor
260 Previous Clinical Trials
66,234 Total Patients Enrolled
Megan L Ranney, MDPrincipal InvestigatorBrown University

Media Library

The Reframe Clinical Trial Eligibility Overview. Trial Name: NCT04804189 — N/A
Gunshot Wound Research Study Groups: Control Group, Intervention Group
Gunshot Wound Clinical Trial 2023: The Reframe Highlights & Side Effects. Trial Name: NCT04804189 — N/A
The Reframe 2023 Treatment Timeline for Medical Study. Trial Name: NCT04804189 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of the participant cohort for this research?

"Affirmative. Clinicaltrials.gov displays that this clinical investigation, which was initially advertised on September 1st 2021, is actively searching for participants. 5500 patients are needed to be recruited at one location."

Answered by AI

Are there available vacancies for enrollees to participate in this experiment?

"Affirmative. Clinicaltrials.gov corroborates that this trial, which was originally posted on September 1st 2021, is now actively recruiting participants. The study needs to enroll 5500 individuals through a single medical centre."

Answered by AI

What are the primary objectives of this research endeavor?

"This clinical trial is intending to measure the Change in Knowledge of Firearm Injuries in the US over 0, 3 and 6 months as it's primary outcome. Moreover, Facilitators of Intervention will be gauged qualitatively via semi-structured interviews with Site Champions and a strategically selected group of adult Club Leaders; this assessment process taking advantage of the Consolidated Framework for Intervention Research. Additionally, implementation metrics such as number of 4-H Club Sessions and community events attended by participants shall also be collected to gauge intervention Feasibility (percentage completing 75% or more activities). Finally, The Ottawa Acceptability Scale (OAS)"

Answered by AI
~1535 spots leftby Apr 2025