Youth Access to Guns in the HomeNCT02136225
Reducing Youth Access to Firearms Through the Health Care Setting
A study testing Means restriction counseling in people with Youth Access to Guns in the Home, run by University of Colorado, Denver.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Youth Access to Guns in the Home
- What is being tested?
- Means restriction counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Youth Access to Guns in the Home
- Being tested
- Means restriction counseling
- Keywords
- youth, gun, access, home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Means restriction counselingBehavioural
Health care providers will counsel parents on the risks of having a gun, particularly an unlocked gun, in the home where youth are present.
| Study group | Role | What they receive |
|---|---|---|
| Counseling | Experimental | 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. Receives: Behavioral: Means restriction counseling |
| Counseling and locking devices | Experimental | 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. Receives: Behavioral: Means restriction counseling |
| Control group | No intervention | Youth in the control group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to one month and one year in the reported number of guns locked in the home.
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.
Measured: 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.
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.
Measured: Baseline, one month, one year
Secondary outcomes (1)
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.
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.
Measured: Baseline, one month, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Youth Access to Guns in the HomeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Boulder
- Responsible party
- Sponsor
- Investigators
- Eric Sigel, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136225
- Sponsor's protocol ID
- 13-2829
- Other IDs
- 2013-MU-CX-0002
- Status last verified
- Apr 2019
- First submitted
- 8 May 2014
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Youth Access to Firearms Through the Health Care Setting
- ClinicalTrials.gov ID
- NCT02136225
- Acronym / sponsor ID
- 13-2829
- Conditions
- Youth Access to Guns in the Home
- Keywords
- youth, gun, access, home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Colorado, Boulder
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Counseling | Experimental | Behavioral: Means restriction counselingIntervention: 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. |
| Counseling and locking devices | Experimental | Behavioral: Means restriction counselingIntervention: 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. |
| Control group | No intervention | –Youth in the control group will receive usual care. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Means restriction counselingHealth care providers will counsel parents on the risks of having a gun, particularly an unlocked gun, in the home where youth are present. | Behavioural | Counseling, Counseling and locking devices |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Sigel, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Means restriction counseling in people with Youth Access to Guns in the Home, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.