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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Joseph A Simonetti, MD MPH
- 電話番号：(330) 714-1648
- メール：Joseph.Simonetti@va.gov
研究連絡先のバックアップ
- 名前：Shalomi Shelton, MS
- 電話番号：(720) 723-6810
- メール：shalomi.shelton@va.gov
研究場所
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
コンタクト：
- Joseph A Simonetti, MD MPH
- 電話番号：(330) 714-1648
- メール：Joseph.Simonetti@va.gov
-
主任研究者：
- Joseph A Simonetti, MD MPH
-
コンタクト：
- Shalomi Shelton, MS
- 電話番号：(720) 723-6810
- メール：shalomi.shelton@va.gov
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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. |
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Meaningful Reduction in Firearm Access (MRIA) at 30 Days
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Who Lock All Household Firearms at 30 Days Among Those Not Locking All Firearms at Baseline
時間枠：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
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Other Increases in Locked Firearm Storage at 30 Days
時間枠：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
時間枠：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
時間枠：30 days
|
Any firearm loaded and unlocked. |
30 days
|
|
Change in Beliefs About the Importance of Locked Firearm Storage
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Joseph A Simonetti, MD MPH、Rocky Mountain Regional VA Medical Center, Aurora, CO
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- HSR4-030-25W
- 1I01RD001918-01A1 (その他の助成金/資金番号：Veterans Health Administration)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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