Testing Family Firearm Secure Storage Training (FFAST) to Prevent Suicide (FFAST RCT)
Improving Secure Storage of Firearms to Reduce Suicide Deaths: A Hybrid Type 1 Implementation Effectiveness Randomized Controlled Trial of the Family Firearms Secure Storage Training (FFAST) Intervention
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
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:Bryann R DeBeer, PhD
- 電話番号:(917) 208-1071
- メール:Bryann.DeBeer@va.gov
研究連絡先のバックアップ
- 名前:Alexis Blessing, PhD
- 電話番号:(720) 723-4808
- メール:alexis.blessing@va.gov
研究場所
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Colorado
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Aurora、Colorado、アメリカ、80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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コンタクト:
- Bryann R DeBeer, PhD
- 電話番号:(917) 208-1071
- メール:Bryann.DeBeer@va.gov
-
主任研究者:
- Bryann R DeBeer, PhD
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-
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Veteran Inclusion Criteria:
- Enrolled or eligible to be enrolled in the VA healthcare system
- enrolled in the Caregiver Program
- able to comprehend the informed consent form and provide consent over the phone or via teleconference
- firearm owner in which they report at least 1 firearm is currently located in the home and stored in an unsecure manner (e.g., unlocked and/or loaded)
- an identifiable CSO enrolled in the VA CSP who agrees to participate
- willing to participate in the follow-up
- technology available to complete the appointment remotely (e.g., computer, tablet, phone)
CSO Inclusion Criteria:
- CSO of Veteran participant (e.g., spouse, friend, relative)
- enrolled in the VA CSP
- able to comprehend the informed consent form and provide consent over the phone or via teleconference
- willing to participate in the follow-up
- willing to assist the Veteran with secure firearm storage
- willing to participate in the follow-up
- technology available to complete the appointment remotely (e.g., computer, tablet, phone)
Exclusion Criteria:
Veteran Exclusion Criteria:
1) At imminent risk of suicide or homicide warranting crisis intervention (Veterans can participate once stabilized)
CSO Exclusion Criteria:
1) At imminent risk of suicide or homicide warranting crisis intervention (CSOs can participate once stabilized)
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:なし(オープンラベル)
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 |
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アクティブコンパレータ:Health and Stress Counseling (HSC)
Participants will participate in an intervention similar in length and delivery of the experimental condition, however the intervention does not focus on lethal means safety, secure storage of firearms, or suicide prevention.
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HSC is a brief intervention where Veterans and their CSOs meet with an interventionist to learn how to support a Veteran's well-being.
Areas include diet, exercise, sleep, stress, and other factors that may impact overall health.
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介入なし:Waitlist
In the waitlist control condition, participants will be assigned to complete either FFAST or HSC 6-months after the start of the study.
Their data for those 6 months will be compared to the intervention (FFAST) and the active control (HSC).
This will allow researchers to compare the results of those who are assigned to either FFAST, HSC, or nothing, while still providing participants an active condition at a later time.
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実験的:The Family Firearms Secure storage Training (FFAST) Intervention
FAST is a brief, single-session intervention where Veterans collaborate with a family member or friend (referred to as a concerned significant other; CSO) to create a secure storage plan for firearms in the event they ever experience a mental health crisis.
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The intervention consists of a brief, single-session intervention where a Veteran and their CSO work together to create a secure storage plan for firearms in the home in the event the Veteran experiences a mental health crisis, and how the CSO can support the Veteran during a crisis.
This intervention can be used by any Veteran who owns firearms, and neither the Veteran nor CSO need to be experiencing mental health symptoms to participate.
The intervention serves as an upstream method of suicide prevention that can be delivered in-person, through a telehealth appointment, or over the phone.
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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 |
|---|---|---|
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Participant Knowledge, Behaviors, and Preparedness Related to Firearm Secure Storage
時間枠:Baseline and 1, 3, 6 months
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Participants will self-report their knowledge, behaviors, and preparedness for enacting a firearm secure storage plan.
Three survey items created for this trial will include knowledge of mental health warning signs, willingness to participate in planning, and preparedness for a mental health crisis.
Unit of Measurement: Total scores of these items will range from 5 - 15, and are rated on a scale of 1 to 5, with higher scores indicating greater levels of agreement on understanding (Definitely Disagree - Definitely Agree) or willingness (Not Willing - Totally Willing).
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Baseline and 1, 3, 6 months
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Number of Participants With a Firearm Secure Storage Plan
時間枠:Baseline and 1, 3, and 6 months
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Participants will be asked via survey their if they have a plan (yes/no), if the plan is written down, and if they have discussed the plan with their Veteran or CSO.
Unit of Measurement: Number of participants
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Baseline and 1, 3, and 6 months
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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 |
|---|---|---|
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Number of Participants Who Report Secure Firearm Storage in the Home
時間枠:Baseline and 1, 3, 6 months
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Self-report assessment of how Veterans store one or all of the firearms in their home.
Secure storage will be defined as either locked (using a gunlock or safe) and unloaded (ammunition removed and separate from the firearm), unlocked and unloaded, or locked and loaded.
Unit of Measurement: Number of participants Measure Type: Categorical (Secure storage as defined above, Unlocked and unloaded, Locked and loaded)
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Baseline and 1, 3, 6 months
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協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者:Bryann R DeBeer, PhD、Rocky Mountain Regional VA Medical Center, Aurora, CO
出版物と役立つリンク
一般刊行物
- DeBeer, B. B., Mattheiu, M. M., Degutis, L. C., Clafferty, S., Blessing, A., Quan, C., & Morissette, S. B. (2025). Firearms lethal means safety in veterans: Attitudes towards involving a concerned significant other. Journal of Military, Veteran, and Family Health, 11(1). https://doi.org/10.3138/jmvfh-2023-0094
- DeBeer B.B, Blessing, A., Degutis, C. D., Matthieu, M. M., Karras, E., Cassidy, R. C., Simonetti, J. A., Borah, E., Mignogna, J. & Morissette, S. B. (2026). Involving concerned significant others in firearm suicide prevention: Development of the Family FireArms Safety Training (FFAST) Intervention. Federal Practitioner, 43(suppl 1), ;S1-S7. https://www.doi.org/10.12788/fp.0695
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
その他の研究ID番号
その他の研究ID番号
- HSR4-004-25M
- 25-2714 (その他の識別子:VA Eastern Colorado Health Care System)
- I01RD000657-01A2 (その他の助成金/資金番号:U.S. Department of Veteran Affairs)
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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