SecureHomes Randomized Clinical Trial (SecureHomes)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Joseph A Simonetti, MD MPH
- Numéro de téléphone: (330) 714-1648
- E-mail: Joseph.Simonetti@va.gov
Sauvegarde des contacts de l'étude
- Nom: Shalomi Shelton, MS
- Numéro de téléphone: (720) 723-6810
- E-mail: shalomi.shelton@va.gov
Lieux d'étude
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Colorado
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Aurora, Colorado, États-Unis, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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Contact:
- Joseph A Simonetti, MD MPH
- Numéro de téléphone: (330) 714-1648
- E-mail: Joseph.Simonetti@va.gov
-
Chercheur principal:
- Joseph A Simonetti, MD MPH
-
Contact:
- Shalomi Shelton, MS
- Numéro de téléphone: (720) 723-6810
- E-mail: shalomi.shelton@va.gov
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Firearms on premises (assessed via Mental Illness Research, Education, and Clinical Center Lethal Means Safety measure)
- Owns at least one of the firearms on premises (assessed via Mental Illness Research, Education, and Clinical Center Lethal Means Safety measure)
- 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)
- Recent VHA ED/UC, PC, OMH encounter who screen positive on the C-SSRS Screener (definition below) - (determined via recruitment database)
Exclusion Criteria:
- Severely cognitively impaired
- Lack decisional capacity
- Are unable to provide consent
- Lack phone access
- Are currently admitted to the hospital
- Have a drug use disorder with current use (other than marijuana)
- Have alcohol use disorder with daily intake
- Participated in the SecureHomes pilot study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
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. |
|
Comparateur actif: 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. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Meaningful Reduction in Firearm Access (MRIA) at 30 Days
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants Who Lock All Household Firearms at 30 Days Among Those Not Locking All Firearms at Baseline
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Other Increases in Locked Firearm Storage at 30 Days
Délai: 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
Délai: 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
Délai: 30 days
|
Any firearm loaded and unlocked. |
30 days
|
|
Change in Beliefs About the Importance of Locked Firearm Storage
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HSR4-030-25W
- 1I01RD001918-01A1 (Autre subvention/numéro de financement: Veterans Health Administration)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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