Reducing Youth Access to Firearms Through the Health Care Setting

April 27, 2019 updated by: University of Colorado, Denver

The purpose of this project is to examine the implementation and effectiveness of an intervention, delivered in a health care setting, to decrease home firearm access by youth. The investigators hypothesize that:

  1. parents who receive means restriction education provided by their primary care provider will be more likely to report, at the one month and one year follow-up, that they are storing their guns locked compared to parents who do not receive means restriction counseling.
  2. parents who receive a free gun locking device(s) will be more likely to report, at the one month and one year follow-up, that they are storing their guns locked compared to parents who receive means restriction counseling alone;
  3. parents whose adolescents are assessed at high risk for violence (> 5 on the Violence Injury Protection and Risk Screen (VIPRS)) or depression (>9 on the Patient Health Questionnaire-9 (PHQ-9)) will be more likely to report storing their gun(s) locked at the one month follow-up compared to parents whose children are assessed as low risk, regardless of whether they receive the counseling alone or counseling plus free locking devices and 4) youth whose parents receive a free gun locking device(s) will be more likely to report less access to guns, at one year follow-up, compared to parents who receive means restriction counseling alone.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient at the Children's Hospital Colorado in the Adolescent Medicine Clinic
  • Scheduled for any type of appointment
  • Reports having a gun in the home

Exclusion Criteria:

  • Adolescent or parent speaks/reads a language other than English or Spanish
  • Adolescent has cognitive disabilities
  • Adolescent resides in a group home or detention center

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Counseling
Intervention: Means restriction counseling. Health care providers will counsel parents on the risks of having a gun, particularly an unlocked gun in the home where youth are present.
Health care providers will counsel parents on the risks of having a gun, particularly an unlocked gun, in the home where youth are present.
Experimental: Counseling and locking devices
Intervention: Means restriction counseling and locking devices. Health care providers will counsel parents on the risks of having a gun, particularly an unlocked gun, in the home where youth are present. Parents will also receive locking devices to store their guns securely.
Health care providers will counsel parents on the risks of having a gun, particularly an unlocked gun, in the home where youth are present.
No Intervention: Control group
Youth in the control group will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to one month and one year in the reported number of guns locked in the home.
Time Frame: Baseline, one month, 1 year
The study examines whether the youth and parents in the treatment groups leads to an increase in the number of guns stored securely (locked) in their home.
Baseline, one month, 1 year
Change from baseline to one month and one year in the reported number of locking devices parents use to store their guns.
Time Frame: Baseline, one month, one year
This study examines whether the youth and parents in the second treatment group, receiving means restriction counseling and locking devices, will increase their use of locking devices compared to youth and parents in the means restriction alone and control groups.
Baseline, one month, one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to one month and one year in the number of gun(s) reported locked in their home among parents whose youth are at high risk for violence or depression.
Time Frame: Baseline, one month, one year
This study examines whether parents whose adolescents are assessed at high risk for violence or depression will be more likely to report, at one month and one year that they are storing their guns locked compared to parents who receive means restriction counseling alone.
Baseline, one month, one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eric Sigel, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimate)

May 12, 2014

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 27, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-2829
  • 2013-MU-CX-0002 (Other Grant/Funding Number: National Institute of Justice)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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