ClinicalTrials.gg
CompletedNCT03386409Updated May 4, 2022

Firearm Storage Device Distribution to Families of Children With Mental Health Complaints

An interventional study of Free safe firearm storage device distribution and Low cost safe firearm storage device in Mental Health Disorders and Suicide or Selfinflicted Injury by Firearms and Explosives, sponsored by Seattle Children's Hospital. Completed at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2022-05-04.

Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Feb 2016, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
255
Allocation
Randomized
Ages
Up to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 386 studies in Suicide with a site in United States — 99 open to participants now, 113 under way, 2 of them phase 3. Suicide · United States.

Enrollment
92nd of 348
255 · median 91
Started
2016
with 14 others
No phase
288 of 386
80 open now
Registered
128th of 386
by date

Among the 386 studies in Suicide with a site in United States, this one is the 92nd largest by enrollment of the 348 interventional ones, is one of 15 that started in 2016, is one of 288 with no phase, and was the 128th registered.

By phase

386 studies; the count open now beside each. This study's row is marked.

No phasethis study288 · 80 open
Observational36 · 5 open
Phase 218 · 7 open
Phase 116 · 3 open
Phase 411 · 0 open
Phase 1/27 · 3 open
Phase 2/35 · 1 open
Phase 35 · 0 open

By the year they started

First in 1990; this study’s year is marked. 15 started in 2016.

Size and results

Median enrollment 91 across the 348 interventional studies, 172 across the 36 observational. Of the 251 that completed or were terminated, 103 (41%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 386 studies in Suicide with a site in United States, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Mental Health Disorders
  • Suicide or Selfinflicted Injury by Firearms and Explosives

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Keywords

  • Injury prevention
04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 .

For adult household members only:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
255 participants (actual)

Study arms

  • No intervention
    Baseline

    Participants receive the standard of care recommendations for safe firearm storage device usage.

  • Experimental
    Free Device

    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.

    Behavioral: Free safe firearm storage device distribution

  • Experimental
    Low Cost Device

    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.

    Behavioral: Low cost safe firearm storage device

Interventions

  • BehavioralFree safe firearm storage device distribution

    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.

  • BehavioralLow cost safe firearm storage device

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 and 30 days post-enrollment

Secondary outcomes

  1. 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

    Time frame: Baseline, 7 days and 30 days post-enrollment

  2. 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

    Time frame: Baseline, 7 days and 30 days post-enrollment

  3. 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

    Time frame: Baseline, 7 days and 30 days post-enrollment

07

Study locations

1 site
  • Seattle Children's
    Seattle, Washington 98105, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2016 to primary completion in Jan 2019, 34 months.

Of 308 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's 34 months is above that.

Counting every sponsor, half of 319 studies reached it within 30 months; a quarter within 15 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2017
First posted
Dec 29, 2017
StartActual
Feb 12, 2016
Primary completionActual
Jan 1, 2019
CompletionActual
Feb 1, 2019
Last update
May 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03386409
Responsible party
Neil Uspal (Assistant Professor, Seattle Children's Hospital) — Principal investigator
First posted
Dec 29, 2017
Start date
Feb 12, 2016
Primary completion
Jan 1, 2019
Completion
Feb 1, 2019
Last update
May 4, 2022

Study contacts

Neil Uspal, MD
principal investigator · Seattle Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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