- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02136225
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:
- 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.
- 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;
- 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
Conditions
Intervention / Treatment
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.
Sponsor
Collaborators
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
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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