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SecureHomes Randomized Clinical Trial (SecureHomes)

6 november 2026 bijgewerkt door: VA Office of Research and Development

A Randomized Clinical Trial of the VA Secure Homes Lethal Means Intervention for Veterans With Elevated Suicide Risk

Firearm suicide prevention is a leading VA priority. To date, no intervention has been shown to encourage Veterans with elevated suicide risk to adopt secure firearm storage practices to reduce their suicide risk. The proposed effort will test whether the SecureHomes intervention can encourage Veterans with elevated suicide risk to adopt secure firearm storage practices, such as voluntarily removing firearms from their households or securing them with locking devices.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The VA Clinical Practice Guidelines encourage clinicians to facilitate secure firearm storage for at-risk Veterans. No such intervention has ever been tested in a clinical trial among Veterans. SecureHomes is an intervention which was found to be feasible and highly acceptable to Veterans. The aim of this trial is to determine the efficacy of the SecureHomes intervention compared to an attention control condition among 400 Veteran firearm owners with elevated suicide risk.

Hypothesis 1a: Veterans who receive SecureHomes will be significantly more likely to report meaningful reductions in firearm access (MRIA) at 30 days compared to Veterans who receive the attention control.

Hypothesis 1b: Among participants who do not store their firearms locked at baseline, Veterans who receive SecureHomes will be significantly more likely to report locking all household firearms at 30 days.

Studietype

Ingrijpend

Inschrijving (Geschat)

400

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045-7211
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Contact:
        • Hoofdonderzoeker:
          • Joseph A Simonetti, MD MPH
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Firearms on premises (assessed via Mental Illness Research, Education, and Clinical Center Lethal Means Safety measure)
  2. Owns at least one of the firearms on premises (assessed via Mental Illness Research, Education, and Clinical Center Lethal Means Safety measure)
  3. Has ACCESS to at least one of the firearms on premises (definition below, via Mental Illness Research, Education, and Clinical Center Lethal Means Safety measure)
  4. Recent VHA ED/UC, PC, OMH encounter who screen positive on the C-SSRS Screener (definition below) - (determined via recruitment database)

Exclusion Criteria:

  1. Severely cognitively impaired
  2. Lack decisional capacity
  3. Are unable to provide consent
  4. Lack phone access
  5. Are currently admitted to the hospital
  6. Have a drug use disorder with current use (other than marijuana)
  7. Have alcohol use disorder with daily intake
  8. Participated in the SecureHomes pilot study

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: SecureHomes

Participants receive the SecureHomes lethal means intervention: one virtual session of about 20-30 minutes plus an optional follow-up of about 5-10 minutes. Sessions are delivered by clinicians with suicide prevention experience who are trained in firearm cultural competency and firearm-specific motivational interviewing. Participants can receive educational print materials and no-cost firearm locking devices based on their preferences.
Gedragsmatig: SecureHomes

A virtually delivered lethal means safety intervention that aims to increase awareness of the link between firearm access and suicide risk and to encourage secure firearm storage. It uses a firearm-specific motivational interviewing approach developed by the study team. It encourages meaningful reduction in firearm access (MRIA) for all participants, and locking all firearms for those not ready to adopt MRIA. Based on participant preference, the study team ships educational print materials and no-cost locking devices (lockboxes and cable locks) to participants' homes.
Actieve vergelijker: Attention Control

Participants receive Health and Stress Counseling, matched in time to the SecureHomes arm: one virtual session of about 20-30 minutes plus an optional follow-up of about 5-10 minutes. Sessions focus on promoting healthy, stress-reducing behaviors and contain no active components specific to firearm storage.
Gedragsmatig: Health and Stress Counseling

An attention control condition matched to SecureHomes in session length and follow-up. Sessions promote healthy and stress-reducing behaviors and contain no firearm-storage knowledge, motivation, or resources.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Meaningful Reduction in Firearm Access (MRIA) at 30 Days
Tijdsspanne: 30 days

MRIA is assessed with the Mental Illness Research, Education, and Clinical Center (MIRECC) Lethal Means Measure. MRIA includes: removal of all household firearms, removal of all household ammunition, all firearms locked with the participant lacking the key or code, all ammunition locked with the participant lacking the key or code, or the firearm disassembled with a critical part kept away from the participant.
30 days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Who Lock All Household Firearms at 30 Days Among Those Not Locking All Firearms at Baseline
Tijdsspanne: 30 days

Assessed with the Mental Illness Research, Education, and Clinical Center (MIRECC) Lethal Means Measure. Participants who stored any household firearm unlocked at baseline are assessed at 30 days. A participant counts if all household firearms are stored locked, using an external locking device or a locked container.
30 days

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Other Increases in Locked Firearm Storage at 30 Days
Tijdsspanne: 30 days

Assessed with the Mental Illness Research, Education, and Clinical Center (MIRECC) Lethal Means Measure. Includes incremental changes in locked firearm storage, including moving from no firearms locked to some firearms locked.
30 days
Number of Participants With Increases in Unloaded Firearm Storage at 30 Days
Tijdsspanne: 30 days

Assessed with the Mental Illness Research, Education, and Clinical Center (MIRECC) Lethal Means Measure. Includes incremental changes in unloaded firearm storage, including from none unloaded to some unloaded, and some unloaded to all unloaded.
30 days
Number of Participants Storing Any Firearm Loaded and Unlocked at 30 Days
Tijdsspanne: 30 days

Any firearm loaded and unlocked.
30 days
Change in Beliefs About the Importance of Locked Firearm Storage
Tijdsspanne: Baseline and 30 days

Changes in agreement from baseline to 30 days in beliefs about the importance of locked firearm storage. Rated on 1-10 scale.
Baseline and 30 days
Change in Firearm Removal Beliefs
Tijdsspanne: Baseline and 30 days

Changes in agreement from baseline to 30 days in beliefs about the importance of removing firearms from the household. Rated on 1-10 scale.
Baseline and 30 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

VA Office of Research and Development

Onderzoekers

  • Hoofdonderzoeker: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 februari 2027

Primaire voltooiing (Geschat)

31 januari 2030

Studie voltooiing (Geschat)

31 januari 2030

Studieregistratiedata

Eerst ingediend

6 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2026

Eerst geplaatst (Werkelijk)

13 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HSR4-030-25W
  • 1I01RD001918-01A1 (Ander subsidie-/financieringsnummer: Veterans Health Administration)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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