SuicideNCT00643812
Improving Firearm Storage in Alaska Native Villages
A study testing Installation of gun locker in household in people with Suicide and Suicide, Attempted, run by University of Washington at 1 site in United States.
Trial summary
Rates of suicide among young Alaska Native males are over ten-fold higher than among a similar age cohort in the rest of the United States. A high proportion of these deaths are associated with firearms. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide, Suicide, Attempted, Wounds and Injuries
- What is being tested?
- Installation of gun locker in household
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Dec 2007
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Households in six villages in Western Alaska that owned a gun, did not own a gun locker, adult age 21 or over
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Injury Prevention and Research Center
Seattle, Washington, 98104
About this study
Rates of suicide among young Alaska Native males are over ten-fold higher than among a similar age cohort in the rest of the United States. A high proportion of these deaths are associated with firearms. Firearms are an important part of the subsistence lifestyle of this population, however restriction of access to guns by youth may be a promising strategy to reduce the risk of suicides in this population. Previous research conducted in the first phase of this project has demonstrated that about 75% of homes in rural southwest Alaskan villages have guns, and only about 15% of these guns are locked; 6% are loaded.
The aims of this specific phase of the study to execute a randomized trial of an intervention to improve firearm storage practices among residents of selected villages. Our hypothesis is that households receiving training and equipment to store firearms in gun lockers will be more likely to store their guns locked at 12 months, compared to households not receiving the intervention.
Read the detailed description
Rates of suicide among young Alaska Native males are over ten-fold higher than among a similar age cohort in the rest of the United States. A high proportion of these deaths are associated with firearms. Firearms are an important part of the subsistence lifestyle of this population, however restriction of access to guns by youth may be a promising strategy to reduce the risk of suicides in this population. Recent work by the HIPRC has shown that locked guns are associated with a 73% reduced risk of suicide, compared to unlocked guns. Similar protective associations were found for unloaded guns. A recent pilot project to improve the storage of guns conducted in southwest Alaska increased the proportion of households having all guns locked from 15% to 85%. The aims of this proposed study are to estimate the prevalence of firearm ownership and of specific firearm storage practices among residents living in the Bristol Bay and Yukon-Kuskokwim regions of southwest Alaska and to work with the Alaska Native health corporations to plan and execute a randomized trial of an intervention to improve firearm storage practices among residents of selected villages. This 3-year study consists of two phases.
The first phase is a regional survey of households within 20 randomly selected villages in southwest Alaska to estimate the extent of firearm ownership and existing storage practices in these communities. This weighted sample would be extrapolated to an overall estimate of these variables for each of the two Native corporations in the region. The second phase of the study will be a two-arm randomized controlled trial of an intervention to increase the proportion of households that store all of their firearms in a locked safe. A secondary outcome will be to reduce the proportion of home reporting the presence of a loaded gun. Households will be randomly assigned to either an early or late intervention group. The 'early' intervention group will receive the intervention at baseline. The 'late' intervention group will receive the intervention 12 months after baseline. All eligible households within participating villages will be educated about the potential protective value of safe firearm storage practices, and then be offered a gun safe to store all of their firearms. Household adults will be trained to use the safe and to carefully restrict access to the guns by youth. Each household will complete a questionnaire about storage practices and important co-variates at baseline, 12 months, and 18 months. Data will be analyzed to detect differences, between groups, in the proportion of homes with unlocked guns, and loaded guns, at 12 and 18 months after baseline. We estimate that the enrollment of 350 homes at baseline should provide 90% power to detect differences of about 16-20 absolute percentage point difference between groups, depending on the baseline prevalence of these variables. This study has the potential to have an important effect on firearm storage patterns in a population at high risk for suicide. If proven successful, it could be disseminated throughout Alaska and other high risk communities.
- Conditions
- Suicide, Suicide, Attempted, Wounds and Injuries
- Being tested
- Installation of gun locker in household
- Keywords
- Firearm storage, Suicide, Unintentional injury, Alaska Native, Suicide Attempt
- Medical subject headings
- Suicide, Suicide, Attempted, Wounds and Injuries, Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Installation of gun locker in householdOther
Also called Gun safes, Gun cabinets
Households were randomized to 'early' and 'late' arms. Each household received a gun locker, which was installed in the household. Early arm received gun lockers at baseline.
Installation of gun locker in householdOther
Also called Gun safes, Gun cabinets
Households were randomized to 'early' and 'late' arms. Each household received a gun locker, which was installed in the household. "Late" arm received the gun locker 12 months after baseline.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The "Early" intervention arm received a gun locker at baseline Receives: Other: Installation of gun locker in household |
| 2 | Active comparator | Households in this arm received a gun locker at 12 months following the baseline survey Receives: Other: Installation of gun locker in household |
What is being measured
The primary outcome is the main question the study is designed to answer.
Household firearm arm storage status: 1. Any unlocked guns in home; 2. Any loaded guns in home; 3. Any unlocked ammunition
Measured: 12 and 18 months after installation of the gun safe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startNov 2004
- Primary completionJun 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Alaska Native Tribal Health Consortium
- Investigators
- David C GRossman, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643812
- Sponsor's protocol ID
- 05-7504-E/G 03
- Status last verified
- Mar 2008
- First submitted
- 20 Mar 2008
- Last updated
- 26 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Grossman DC, Stafford HA, Koepsell TD, Hill R, Retzer KD, Jones W. Improving firearm storage in Alaska native villages: a randomized trial of household gun cabinets. Am J Public Health. 2012 May;102 Suppl 2(Suppl 2):S291-7. doi: 10.2105/AJPH.2011.300421. Epub 2012 Mar 8.
PubMed 22401514
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Firearm Storage in Alaska Native Villages
- ClinicalTrials.gov ID
- NCT00643812
- Acronym / sponsor ID
- 05-7504-E/G 03
- Conditions
- Suicide, Suicide, Attempted, Wounds and Injuries
- Keywords
- Firearm storage, Suicide, Unintentional injury, Alaska Native, Suicide Attempt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Alaska Native Tribal Health Consortium
- Study start
- Nov 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 26 Mar 2008 (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.
Rates of suicide among young Alaska Native males are over ten-fold higher than among a similar age cohort in the rest of the United States. A high proportion of these deaths are associated with firearms. Firearms are an important part of the subsistence lifestyle of this population, however restriction of access to guns by youth may be a promising strategy to reduce the risk of suicides in this population. Previous research conducted in the first phase of this project has demonstrated that about 75% of homes in rural southwest Alaskan villages have guns, and only about 15% of these guns are locked; 6% are loaded.
The aims of this specific phase of the study to execute a randomized trial of an intervention to improve firearm storage practices among residents of selected villages. Our hypothesis is that households receiving training and equipment to store firearms in gun lockers will be more likely to store their guns locked at 12 months, compared to households not receiving the intervention.
Detailed description
Rates of suicide among young Alaska Native males are over ten-fold higher than among a similar age cohort in the rest of the United States. A high proportion of these deaths are associated with firearms. Firearms are an important part of the subsistence lifestyle of this population, however restriction of access to guns by youth may be a promising strategy to reduce the risk of suicides in this population. Recent work by the HIPRC has shown that locked guns are associated with a 73% reduced risk of suicide, compared to unlocked guns. Similar protective associations were found for unloaded guns. A recent pilot project to improve the storage of guns conducted in southwest Alaska increased the proportion of households having all guns locked from 15% to 85%. The aims of this proposed study are to estimate the prevalence of firearm ownership and of specific firearm storage practices among residents living in the Bristol Bay and Yukon-Kuskokwim regions of southwest Alaska and to work with the Alaska Native health corporations to plan and execute a randomized trial of an intervention to improve firearm storage practices among residents of selected villages. This 3-year study consists of two phases.
The first phase is a regional survey of households within 20 randomly selected villages in southwest Alaska to estimate the extent of firearm ownership and existing storage practices in these communities. This weighted sample would be extrapolated to an overall estimate of these variables for each of the two Native corporations in the region. The second phase of the study will be a two-arm randomized controlled trial of an intervention to increase the proportion of households that store all of their firearms in a locked safe. A secondary outcome will be to reduce the proportion of home reporting the presence of a loaded gun. Households will be randomly assigned to either an early or late intervention group. The 'early' intervention group will receive the intervention at baseline. The 'late' intervention group will receive the intervention 12 months after baseline. All eligible households within participating villages will be educated about the potential protective value of safe firearm storage practices, and then be offered a gun safe to store all of their firearms. Household adults will be trained to use the safe and to carefully restrict access to the guns by youth. Each household will complete a questionnaire about storage practices and important co-variates at baseline, 12 months, and 18 months. Data will be analyzed to detect differences, between groups, in the proportion of homes with unlocked guns, and loaded guns, at 12 and 18 months after baseline. We estimate that the enrollment of 350 homes at baseline should provide 90% power to detect differences of about 16-20 absolute percentage point difference between groups, depending on the baseline prevalence of these variables. This study has the potential to have an important effect on firearm storage patterns in a population at high risk for suicide. If proven successful, it could be disseminated throughout Alaska and other high risk communities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Installation of gun locker in householdThe "Early" intervention arm received a gun locker at baseline |
| 2 | Active comparator | Other: Installation of gun locker in householdHouseholds in this arm received a gun locker at 12 months following the baseline survey |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Households in six villages in Western Alaska that owned a gun, did not own a gun locker, adult age 21 or over
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Installation of gun locker in householdAlso: Gun safes, Gun cabinetsHouseholds were randomized to 'early' and 'late' arms. Each household received a gun locker, which was installed in the household. Early arm received gun lockers at baseline. | Other | 1 |
| Installation of gun locker in householdAlso: Gun safes, Gun cabinetsHouseholds were randomized to 'early' and 'late' arms. Each household received a gun locker, which was installed in the household. "Late" arm received the gun locker 12 months after baseline. | Other | 2 |
Primary outcome
Household firearm arm storage status: 1. Any unlocked guns in home; 2. Any loaded guns in home; 3. Any unlocked ammunition
Time frame: 12 and 18 months after installation of the gun safe
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 26 Mar 2008.
- Derived from this study: PubMed 22401514Grossman DC, Stafford HA, Koepsell TD, Hill R, Retzer KD, Jones W. Improving firearm storage in Alaska native villages: a randomized trial of household gun cabinets. Am J Public Health. 2012 May;102 Suppl 2(Suppl 2):S291-7. doi: 10.2105/AJPH.2011.300421. Epub 2012 Mar 8.
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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.
David C GRossman, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Installation of gun locker in household in people with Suicide and Suicide, Attempted, run by University of Washington at 1 site in United States.
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 1 inclusion and 0 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 26 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Household firearm arm storage status: 1. Any unlocked guns in home; 2. Any loaded guns in home; 3. Any unlocked ammunition (time frame: 12 and 18 months after installation of the gun safe). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00643812, which also lists 1 linked publication.
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 26 Mar 2008.