Home Safety Intervention

NCT06216327 | Completed Results

• 2 other identifiers: CDX 24-0011IK2HX002861-01A2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Access to lethal methods of self-harm such as firearms and medications increases risk for suicide. As such, VA/DoD guidelines for the care of individuals with elevated suicide risk include recommendations that clinicians deliver interventions to reduce access to lethal methods of suicide among patients who are identified as having elevated suicide risk. However, no interventions have been developed or tested among Veterans with elevated suicide risk. The aim of this study is to pilot test a lethal means safety intervention developed specifically for Veterans who seek care in VHA clinical settings and are identified as having elevated suicide risk.

Conditions

Suicide; Firearm Injury; Overdose

Keywords

firearm

Outcome Measures

Primary Outcomes (8)

• Feasibility: Number of Participants Recruited Within One Year

  Ability to recruit 40 Veterans in one year. Count represents number of participants recruited within one year.

  through study completion, an average of one year

• Feasibility: Number of Participants Who Attend Their 4 Week Follow Up

  \>80% of participants attend their 4 week follow up. Count represents number of participants who completed their 4 week follow up visit.

  approximately 4 weeks

• Acceptability: Number of Participants With CSQ Scores ≥24

  \>80% with score greater than 23 (Client Satisfaction Questionnaire 8). 8 items, each with 4 answer options (1-4) on a Likert Scale. Likert options are different for each item. Score range is 8 to 32. Higher scores indicate higher satisfaction.

  day of intervention delivery - day 0; and at 4 weeks

• Acceptability: Number of Participants Who Reported the Intervention to be Acceptable

  Count of participants who deemed the intervention acceptable via a qualitative evaluation of participant's experiences during the intervention. Assessed using the Narrative Evaluation of Intervention Interview (NEII): A 16-item semi-structured qualitative interview that helps participants evaluate the process and outcome of interventions.

  at 4 weeks

• Number of Participants Who Found the Intervention Discussion to be Comfortable/Very Comfortable

  Count represent the number of participants who reported feeling "Comfortable" or "Very comfortable". "How comfortable did you feel engaging in the discussion?" Likert responses: * Very uncomfortable * Uncomfortable * Neither * Comfortable * Very comfortable

  day of intervention delivery - day 0; and at 4 weeks

• Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Medication Storage Decisions

  Count represent the number of participants who reported that their interaction was "Very helpful" or "Extremely helpful". "How helpful was your interaction in making decisions about medication storage and safety?" Likert responses: * Not at all * Slightly helpful * Moderately helpful * Very helpful * Extremely helpful

  day of intervention delivery - day 0; and at 4 weeks

• Number of Participants Who Found the Intervention to be Very Helpful/Extremely Helpful in Firearm Storage Decisions

  Count represent the number of participants who reported that their interaction was "Very helpful" or "Extremely helpful". "How helpful was your interaction in making decisions about firearm storage?" Likert responses: * Not at all * Slightly helpful * Moderately helpful * Very helpful * Extremely helpful

  day of intervention delivery - day 0; and at 4 weeks

• Number of Participants Who Found the Intervention to be Respectful/Very Respectful of Their Values as Firearm Owners

  Count represents the number of participants who reported that their interaction was "Respectful" or "Very respectful". "To what extent was this intervention respectful of your values as a firearm owner? Likert responses: * Very disrespectful * Disrespectful * Neither * Respectful * Very respectful

  day of intervention delivery - day 0; and at 4 weeks

Secondary Outcomes (20)

• Average Participant Trust in the VA Healthcare System

  Day of intervention delivery (day 0) and at 4 weeks

• Average Participant Beliefs About Importance of Secure Medication Storage When Someone is Suicidal

  Day of intervention delivery (day 0) and at 4 weeks

• Average Participant Beliefs About Importance of Secure Medication Storage Always

  Day of intervention delivery (day 0) and at 4 weeks

• Average Participant Beliefs About Importance of Secure Firearm Storage When Someone is Suicidal

  Day of intervention delivery (day 0) and at 4 weeks

• Average Participant Beliefs About Importance of Secure Firearm Storage Always

  Day of intervention delivery (day 0) and at 4 weeks

Study Arms (1)

Intervention arm

EXPERIMENTAL

There is a single intervention arm with no comparator for this pilot study.

Behavioral: household safety intervention

Interventions

household safety intervention BEHAVIORAL

This intervention includes a household safety intervention that is delivered by an interventionist with specific training in facilitating lethal means safety discussions, and the provision of no-cost safety devices for medications and firearms.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Encounter at VHA ED or urgent care setting, outpatient mental health, women's health, or primary care
• \>17 years
• Discharged home from the encounter (rather than hospital admission)
• Positive Columbia Screener
• Patient-reported access to self-owned firearms and/or medications

You may not qualify if:

• Unable to consent due to cognitive impairment, severity of illness (including psychiatric symptoms), intoxication with drugs and/or alcohol
• Unreliable telephone access
• Unreliable video access (because remote intervention)
• Those currently experiencing unsheltered homelessness
• No mailing address
• Active opioid or stimulant use disorder
• Active alcohol use disorder with daily alcohol consumption

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

MeSH Terms

Conditions

Suicide; Drug Overdose

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Joseph Simonetti
• Organization: Rocky Mountain Regional VA Medical Center

joseph.simonetti@va.gov

(720) 723-6491

Study Officials

• Joseph A Simonetti, MD MPH

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This intervention includes a household safety intervention that is delivered by an interventionist with specific training in facilitating lethal means safety discussions, and the provision of no-cost safety devices for medications and firearms.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 22, 2024
• Study Start: October 8, 2024
• Primary Completion: July 18, 2025
• Study Completion: August 18, 2025
• Last Updated: August 28, 2026
• Results First Posted: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)