[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07692854":3,"trial-entities:NCT07692854":104,"trial-summary:NCT07692854":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":47,"secondary_outcomes":56,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":68,"locations":71,"central_contacts":89,"overall_officials":95,"references":97,"see_also_links":103},"NCT07692854","HSR4-004-25M","Testing Family Firearm Secure Storage Training (FFAST) to Prevent Suicide","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","NOT_YET_RECRUITING","2030-09-30","2026-07","2026-07-16","2026-10-01","VA Office of Research and Development","FED",false,"Firearms are the lethal means used in over 70% of Veteran suicides with rates of Veteran deaths via self-induced firearm injury rising dramatically (by 64.8%) from 2001 to 2022. Upstream, evidence-based lethal means safety interventions are urgently needed within the VA to address this serious issue. The Family Firearms Secure Storage Training (FFAST) intervention consists of single session in which Veterans and their concerned significant others (CSOs) are guided through a discussion on secure firearm storage practices and develop a safety plan to prepare them for a mental health crisis. This study aims to evaluate the relative effectiveness of FFAST against a control condition in promoting secure firearm storage planning, preparedness for a mental health crisis, and secure storage practices within Veterans and their CSOs. In addition, barriers and facilitating factors of implementing FFAST within the VA Caregiver Support Program and Suicide Prevention 2.0 will be examined to aid in the widespread adoption of FFAST across the VA.","Firearm injuries are the most common lethal means in Veteran suicides (73%; VA, 2024). Storing firearms unlocked and\u002For loaded is associated with greater risk for suicide via firearm. Time and distance from firearms are critical, especially when an individual may be experiencing a crisis exacerbated by an existing mental health condition. New suicide prevention interventions are needed that reach individuals before the onset of a mental health crisis, and Veterans indicate they desire to include a concerned significant other (CSO; e.g., family member, friend) in their suicide prevention care. Innovation and Impact: Aligned with the VA National Strategy for Suicide Prevention goal of to developing programs that promote Veteran well-being, prevent suicide, and establish contingencies to reduce access to lethal means in the onset of suicide-related behaviors, the goal of this proposed study is to evaluate The Family FireArms Secure Storage Training (FFAST). The FFAST intervention is a single-session lethal means safety intervention, developed through stakeholder engagement, that incorporates the participation of a CSO to facilitate secure firearm storage prior to a mental health crisis. FFAST consists of four primary components: 1) CSO Involvement: participants are briefed on the importance and role of the CSO in the intervention, how they serve as an encouraging support person for the Veteran; 2) Psychoeducation: throughout the intervention, participants are briefed and engage in discussions on mental health symptoms, suicide warning signs, Veteran suicide rates and lethal means, and benefits of secure storage; 3) Secure Firearm Storage: educate and explore secure storage options with participants; and 4) Crisis Situation: participants navigate through a mock crisis scenario to practice their newly developed safety plan and increase comfort in discussing mental health and suicidal crisis. After being tested in two pilots (Suicide Prevention Research Impact Network \\[SPRINT\\], VA Health Sciences Research and Development \\[HSR\\], \\& VA Office of Suicide Prevention \\[OSP\\], PI: DeBeer), collected data indicate the intervention is acceptable and feasible, and recruitment and retention procedures have been refined for future comparative testing and implementation. Specific Aims: Objective 1) Examine the relative effectiveness of FFAST against both active (i.e., Health and Stress Counseling) and waitlist control condition in increasing secure firearm storage within Veterans over time, as well as increasing CSOs' willingness to address a mental health crisis experienced by the Veteran; and Objective 2) Identify the barriers and facilitating factors of implementing the FFAST intervention within the VA Caregiver Support Program and Suicide Prevention 2.0. Methodology: Utilizing a 3-arm dynamic waitlist hybrid type I implementation\u002Feffectiveness randomized controlled trial (RCT) design, Veterans (n = 88) who store firearms in their home unlocked and\u002For loaded, and their CSOs (n = 88) will be recruited and randomly assigned to complete one of the three arms. Outcomes assessed at 1-,3-, and 6-month follow-up will include prevalence of engagement in secure firearm storage planning, practices (e.g., increases in locked and\u002For unloaded firearms or removal from home for safety), and mental health crisis preparedness in Veterans and their CSOs. In addition, a formative evaluation via key informant qualitative interviews with VA Caregiver Program and Suicide Prevention 2.0 providers and administrators (N = 20) will be conducted to facilitate future implementation efforts. Further, in-depth qualitative interviews will be conducted with a sub-set of Veterans and CSOs to understand their experiences with the intervention and inform implementation efforts. Path to Translation\u002FImplementation: This trial will be the next step in our overall aim to prevent veteran suicide through an upstream, evidence-based suicide prevention intervention, and pave the way for FFAST to be disseminated and implemented widely across the VA.",[19,20,21],"Lethal Means Safety","Brief Intervention","Concern Significant Others",[19,23,24,25,26,27,28],"Veterans","Suicide Prevention","Concerned Significant Others","Secure Storage","Firearms","Intervention","INTERVENTIONAL","PREVENTION",[32],"NA",{"count":34,"type":35},176,"ESTIMATED",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","The Family Firearms Secure storage Training (FFAST) Intervention","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.",[39],{"type":38,"name":43,"description":44,"armGroupLabels":45},"Health and Stress Counseling","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.",[46],"Health and Stress Counseling (HSC)",[48,52],{"measure":49,"description":50,"timeFrame":51},"Number of Participants With a Firearm Secure Storage Plan","Participants will be asked via survey their if they have a plan (yes\u002Fno), if the plan is written down, and if they have discussed the plan with their Veteran or CSO. Unit of Measurement: Number of participants","Baseline and 1, 3, and 6 months",{"measure":53,"description":54,"timeFrame":55},"Participant Knowledge, Behaviors, and Preparedness Related to Firearm Secure Storage","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).","Baseline and 1, 3, 6 months",[57],{"measure":58,"description":59,"timeFrame":55},"Number of Participants Who Report Secure Firearm Storage in the Home","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)","ALL","18 Years","80 Years",true,{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"Inclusion Criteria:\n\nVeteran Inclusion Criteria:\n\n1. Enrolled or eligible to be enrolled in the VA healthcare system\n2. enrolled in the Caregiver Program\n3. able to comprehend the informed consent form and provide consent over the phone or via teleconference\n4. 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\u002For loaded)\n5. an identifiable CSO enrolled in the VA CSP who agrees to participate\n6. willing to participate in the follow-up\n7. technology available to complete the appointment remotely (e.g., computer, tablet, phone)\n\nCSO Inclusion Criteria:\n\n1. CSO of Veteran participant (e.g., spouse, friend, relative)\n2. enrolled in the VA CSP\n3. able to comprehend the informed consent form and provide consent over the phone or via teleconference\n4. willing to participate in the follow-up\n5. willing to assist the Veteran with secure firearm storage\n6. willing to participate in the follow-up\n7. technology available to complete the appointment remotely (e.g., computer, tablet, phone)\n\nExclusion Criteria:\n\nVeteran Exclusion Criteria:\n\n1\\) At imminent risk of suicide or homicide warranting crisis intervention (Veterans can participate once stabilized)\n\nCSO Exclusion Criteria:\n\n1\\) At imminent risk of suicide or homicide warranting crisis intervention (CSOs can participate once stabilized)",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":86},"Rocky Mountain Regional VA Medical Center, Aurora, CO","Aurora","Colorado","80045-7211","United States",[79,84],{"name":80,"role":81,"phone":82,"email":83},"Bryann R DeBeer, PhD","CONTACT","(917) 208-1071","Bryann.DeBeer@va.gov",{"name":80,"role":85},"PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},39.72943,-104.83192,[90,91],{"name":80,"role":81,"phone":82,"email":83},{"name":92,"role":81,"phone":93,"email":94},"Alexis Blessing, PhD","(720) 723-4808","alexis.blessing@va.gov",[96],{"name":80,"affiliation":73,"role":85},[98,101],{"type":99,"citation":100},"BACKGROUND","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:\u002F\u002Fwww.doi.org\u002F10.12788\u002Ffp.0695",{"type":99,"citation":102},"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:\u002F\u002Fdoi.org\u002F10.3138\u002Fjmvfh-2023-0094",[],{"nct_id":4,"conditions":105,"biomarkers":106},[24],[],{"nct_id":4,"found":63,"summary":108,"prompt_version":117},{"design":109,"status":110,"heading":6,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is an interventional study planning to enroll 176 participants. It compares two behavioral interventions: Family Firearm Secure Storage Training (FFAST) and Health and Stress Counseling.","completed","This study is testing an intervention called Family Firearm Secure Storage Training (FFAST) to help prevent suicide among Veterans. The FFAST intervention involves a single session where a Veteran and a concerned significant other (CSO), like a family member or friend, work together to create a secure plan for firearms in the home, especially if the Veteran experiences a mental health crisis. Another group will receive Health and Stress Counseling, which focuses on overall well-being. The study aims to see if FFAST helps participants create secure firearm storage plans and improves their knowledge and preparedness for secure storage. You may be able to join if you are a Veteran aged 18-80, enrolled in the VA healthcare system and Caregiver Program, and own a firearm stored unsecured in your home. The study is currently recruiting 176 participants, but its exact status is unclear.","Participants will be followed for 6 months after the intervention to assess their secure storage plans and related knowledge and behaviors.",142,"Participants will engage in a brief, single-session intervention. Their knowledge, behaviors, and preparedness related to firearm secure storage will be measured at the start, and again at 1, 3, and 6 months.","Not stated in the trial record.",[43],"v2"]