Mental Health DisordersNCT03386409
Firearm Storage Device Distribution to Families of Children With Mental Health Complaints
A study testing Free safe firearm storage device distribution and Low cost safe firearm storage device in people with Mental Health Disorders and Suicide or Selfinflicted Injury by Firearms and Explosives, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
This study aims to describe the baseline rate of safe firearm storage device use in the homes of pediatric patients with mental health complaints treated in the Emergency Department (ED) and/or inpatient psychiatric unit of an urban tertiary pediatric hospital. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Mental Health Disorders, Suicide or Selfinflicted Injury by Firearms and Explosives
- What is being tested?
- Free safe firearm storage device distribution and Low cost safe firearm storage device
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2016to 1 Feb 2019
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-17 years, inclusive
- Evaluated in the Emergency Department or inpatient psychiatric unit for a primary mental health complaint
- Presence of a firearm in household where patient resides at least one day per week and/or will reside for at least one of the 7 days following enrollment
- Accompanied by a parent or legal guardian
- Parent or legal guardian is proficient in English
- Parent or legal guardian is 18 years of age or older
Show all 10Show fewer
- 18 years of age or older
- Lives in same household as patient at least one day per week
- Has primary or shared responsibility for at least one firearm stored in the household
- Proficient in English
Who cannot join
- Patient is 18 years of age or older
- Patient is not evaluated for a mental health complaint in the Emergency Department or inpatient psychiatric unit
- The adult participant has previously enrolled in the intervention phase of the study.
- Patient is accompanied by a parent/legal guardian who has previously enrolled a different child in the intervention phase of the study
- Patient is not accompanied by a parent or legal guardian during their PMBU or ED visit
- Parent or legal guardian accompanying patient does not reside and/or does not anticipate residing in the household with patient for any of the 7 days following enrollment and no other adult household member is present to consent Note: Adult household members may only consent to participate in this study if a parent or legal guardian is also present to provide informed consent.
Show all 9Show fewer
- For adult household members only:
- Resides in household with patient less than one day per week, and/or does not anticipate residing in the household with patient for any of the 7 days following enrollment
- Is not responsible for firearm storage in the home
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Firearm Safety Device Distribution on Firearm Exposure in the Households of Patients With Mental Health Complaints
This study aims to describe the baseline rate of safe firearm storage device use in the homes of pediatric patients with mental health complaints treated in the Emergency Department (ED) and/or inpatient psychiatric unit of an urban tertiary pediatric hospital.
Follow-up data will be collected to ascertain any change(s) in the rate of safe firearm storage device use after patients have been treated for a mental health complaint, which includes standardized recommendations for safe firearm storage practices. This study also involves an intervention to distribute safe firearm storage devices to families of pediatric mental health patients during their hospital visit, and assesses whether safe storage device distribution impacts reported future rate of firearm safety device use.
Read the detailed description
Firearm injuries are a significant cause of morbidity and mortality for children and teens. Access to firearms has been associated with suicide completion in the pediatric mental health population. Current practice in our pediatric Emergency Department (ED) and inpatient psychiatric unit is to screen all mental health patients for firearm access, and to recommend safe firearm storage practices. However, there is no data on the baseline rate of safe firearm storage device use in the homes of these patients, or on the effectiveness of providing these recommendations during hospitalization.
This study has two phases, a baseline and an intervention. During the baseline phase, the research team will study whether there is an improvement in safe firearm storage device use in the homes of participants 7 or 30 days after safe storage practices are recommended during an ED or inpatient psychiatric visit. During the intervention phase, in addition to the standard recommendation of safe storage practices during the visit, the research team will distribute firearm safety storage devices such as a lock box, trigger lock, and and/or cable lock to families at the time of study enrollment. The investigators will study whether there is an improvement in safe firearm storage device use in the homes of intervention participants after 7 or 30 days compared to the usual care group.
- Being tested
- Free safe firearm storage device distribution, Low cost safe firearm storage device
- Keywords
- Injury prevention
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free safe firearm storage device distributionBehavioural
Participants in the experimental phase of the study receive a safe firearm storage device at the time of study enrollment. They are randomized to receive a free device. Safe firearm storage devices include a California Department of Justice-approved lock box, trigger lock and/or cable lock.
Low cost safe firearm storage deviceBehavioural
Participants in the experimental phase of the study receive a safe firearm storage device at the time of study enrollment. They are randomized to receive a low cost ($5) device. Safe firearm storage devices include a California Department of Justice-approved lock box, trigger lock and/or cable lock.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | Participants receive the standard of care recommendations for safe firearm storage device usage. |
| Free Device | Experimental | Participants receive the standard of care recommendations for safe firearm storage device usage In addition, the study intervention is provision of a free safe firearm storage device (lock box, trigger lock and/or cable lock) for firearm storage at the time of enrollment. Receives: Behavioral: Free safe firearm storage device distribution |
| Low Cost Device | Experimental | Participants receive the standard of care recommendations for safe firearm storage device usage. In addition, the study intervention is the provision of a low cost ($5) firearm storage device (lock box, trigger lock and/or cable lock) for firearm storage at the time of enrollment. Receives: Behavioral: Low cost safe firearm storage device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of unsecured firearms stored in the household.
Comparison in the participant-reported number of unsecured firearms stored in their household at the time of enrollment, 7 days post-enrollment, and 30 days post-enrollment.
Measured: 7 and 30 days post-enrollment
Secondary outcomes (3)
Proportion of participants with all firearms safely secured
Description of participants with all firearms secured using "triple safe" storage methods: firearms stored in a locked location, unloaded, and with ammunition stored in a separate, locked location
Measured: Baseline, 7 days and 30 days post-enrollment
Proportion of participants who report storing fewer firearms in their homes at follow-up
Description of participants who report storing fewer firearms in their homes during follow-up surveys compared to reported number of firearms at baseline
Measured: Baseline, 7 days and 30 days post-enrollment
Proportion of participants who report using a firearm safety storage device at follow-up
Description of participants who report using any safe firearm storage device at follow-up, change in any safe firearm storage device use from baseline
Measured: Baseline, 7 days and 30 days post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start12 Feb 2016
- Primary completion1 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisordersStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Sequential
- Model description
- In the first phase of the study, all participants are assigned to an observational baseline group. Once the enrollment milestone is met, the second phase of the study will open. In this phase, participants all receive the intervention of safe firearm storage device distribution. Participants are randomized to either the free device group, or the low cost ($5) device group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Uspal, Seattle Children's Hospital
- Investigators
- Neil Uspal, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386409
- Sponsor's protocol ID
- 00000009
- Status last verified
- May 2022
- First submitted
- 21 Dec 2017
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Firearm Safety Device Distribution on Firearm Exposure in the Households of Patients With Mental Health Complaints
- ClinicalTrials.gov ID
- NCT03386409
- Acronym / sponsor ID
- 00000009
- Keywords
- Injury prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 12 Feb 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 29 Dec 2017 (actual)
- 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.
This study aims to describe the baseline rate of safe firearm storage device use in the homes of pediatric patients with mental health complaints treated in the Emergency Department (ED) and/or inpatient psychiatric unit of an urban tertiary pediatric hospital.
Follow-up data will be collected to ascertain any change(s) in the rate of safe firearm storage device use after patients have been treated for a mental health complaint, which includes standardized recommendations for safe firearm storage practices. This study also involves an intervention to distribute safe firearm storage devices to families of pediatric mental health patients during their hospital visit, and assesses whether safe storage device distribution impacts reported future rate of firearm safety device use.
Detailed description
Firearm injuries are a significant cause of morbidity and mortality for children and teens. Access to firearms has been associated with suicide completion in the pediatric mental health population. Current practice in our pediatric Emergency Department (ED) and inpatient psychiatric unit is to screen all mental health patients for firearm access, and to recommend safe firearm storage practices. However, there is no data on the baseline rate of safe firearm storage device use in the homes of these patients, or on the effectiveness of providing these recommendations during hospitalization.
This study has two phases, a baseline and an intervention. During the baseline phase, the research team will study whether there is an improvement in safe firearm storage device use in the homes of participants 7 or 30 days after safe storage practices are recommended during an ED or inpatient psychiatric visit. During the intervention phase, in addition to the standard recommendation of safe storage practices during the visit, the research team will distribute firearm safety storage devices such as a lock box, trigger lock, and and/or cable lock to families at the time of study enrollment. The investigators will study whether there is an improvement in safe firearm storage device use in the homes of intervention participants after 7 or 30 days compared to the usual care group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- In the first phase of the study, all participants are assigned to an observational baseline group. Once the enrollment milestone is met, the second phase of the study will open. In this phase, participants all receive the intervention of safe firearm storage device distribution. Participants are randomized to either the free device group, or the low cost ($5) device group.
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Participants receive the standard of care recommendations for safe firearm storage device usage. |
| Free Device | Experimental | Behavioral: Free safe firearm storage device distributionParticipants receive the standard of care recommendations for safe firearm storage device usage In addition, the study intervention is provision of a free safe firearm storage device (lock box, trigger lock and/or cable lock) for firearm storage at the time of enrollment. |
| Low Cost Device | Experimental | Behavioral: Low cost safe firearm storage deviceParticipants receive the standard of care recommendations for safe firearm storage device usage. In addition, the study intervention is the provision of a low cost ($5) firearm storage device (lock box, trigger lock and/or cable lock) for firearm storage at the time of enrollment. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age 0-17 years, inclusive
- Evaluated in the Emergency Department or inpatient psychiatric unit for a primary mental health complaint
- Presence of a firearm in household where patient resides at least one day per week and/or will reside for at least one of the 7 days following enrollment
- Accompanied by a parent or legal guardian
- Parent or legal guardian is proficient in English
Key exclusion criteria (9 listed)
- Patient is 18 years of age or older
- Patient is not evaluated for a mental health complaint in the Emergency Department or inpatient psychiatric unit
- The adult participant has previously enrolled in the intervention phase of the study.
- Patient is accompanied by a parent/legal guardian who has previously enrolled a different child in the intervention phase of the study
- Patient is not accompanied by a parent or legal guardian during their PMBU or ED visit
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 |
|---|---|---|
| Free safe firearm storage device distributionParticipants in the experimental phase of the study receive a safe firearm storage device at the time of study enrollment. They are randomized to receive a free device. Safe firearm storage devices include a California Department of Justice-approved lock box, trigger lock and/or cable lock. | Behavioural | Free Device |
| Low cost safe firearm storage deviceParticipants in the experimental phase of the study receive a safe firearm storage device at the time of study enrollment. They are randomized to receive a low cost ($5) device. Safe firearm storage devices include a California Department of Justice-approved lock box, trigger lock and/or cable lock. | Behavioural | Low Cost Device |
Primary outcome
Change in the number of unsecured firearms stored in the household.
Time frame: 7 and 30 days post-enrollment
Comparison in the participant-reported number of unsecured firearms stored in their household at the time of enrollment, 7 days post-enrollment, and 30 days post-enrollment.
3 secondary outcomes
Proportion of participants with all firearms safely secured
Time frame: Baseline, 7 days and 30 days post-enrollment
Proportion of participants who report storing fewer firearms in their homes at follow-up
Time frame: Baseline, 7 days and 30 days post-enrollment
Proportion of participants who report using a firearm safety storage device at follow-up
Time frame: Baseline, 7 days and 30 days post-enrollment
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 4 May 2022.
- Individual participant dataSharing planned: No
Related trials for Mental Health Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
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.
Neil Uspal, MD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free safe firearm storage device distribution and Low cost safe firearm storage device in people with Mental Health Disorders and Suicide or Selfinflicted Injury by Firearms and Explosives, run by Seattle Children's Hospital 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 10 inclusion and 9 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 4 May 2022. 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?
Change in the number of unsecured firearms stored in the household. (time frame: 7 and 30 days post-enrollment). 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 4 May 2022.