Home Safety Intervention

NCT06216327 | Completed

• 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 of study recruitment

  Ability to recruit 30 Veterans in one year

  through study completion, an average of one year

• Feasibility of study follow up

  \>70% follow up

  approximately 30 days

• participant intervention satisfaction

  \>70% 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.

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

• participant intervention satisfaction

  Qualitative evaluation of participant's experiences

  at 4 weeks

• Comfort with intervention discussion

  "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

• Intervention helpfulness in medication decisions

  "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

• Intervention helpfulness in firearm decisions

  "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

• Respectfulness of the intervention

  "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 (18)

• Institutional Trust

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

• Beliefs about importance of secure medication storage when someone is suicidal

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

• Beliefs about importance of secure medication storage always

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

• Beliefs about importance of secure firearm storage when someone is suicidal

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

• 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

Study Officials

• Joseph A Simonetti, MD MPH

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

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: June 27, 2024
• Primary Completion: July 18, 2025
• Study Completion: August 18, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)