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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Joseph A Simonetti, MD MPH
- 전화번호: (330) 714-1648
- 이메일: Joseph.Simonetti@va.gov
연구 연락처 백업
- 이름: Shalomi Shelton, MS
- 전화번호: (720) 723-6810
- 이메일: shalomi.shelton@va.gov
연구 장소
-
-
Colorado
-
Aurora, Colorado, 미국, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
연락하다:
- Joseph A Simonetti, MD MPH
- 전화번호: (330) 714-1648
- 이메일: Joseph.Simonetti@va.gov
-
수석 연구원:
- Joseph A Simonetti, MD MPH
-
연락하다:
- Shalomi Shelton, MS
- 전화번호: (720) 723-6810
- 이메일: shalomi.shelton@va.gov
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Meaningful Reduction in Firearm Access (MRIA) at 30 Days
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants Who Lock All Household Firearms at 30 Days Among Those Not Locking All Firearms at Baseline
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Other Increases in Locked Firearm Storage at 30 Days
기간: 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
기간: 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
기간: 30 days
|
Any firearm loaded and unlocked. |
30 days
|
|
Change in Beliefs About the Importance of Locked Firearm Storage
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- HSR4-030-25W
- 1I01RD001918-01A1 (기타 보조금/기금 번호: Veterans Health Administration)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .