Trial Outcomes & Findings for Decision Making Tool for Firearm Storage (NCT NCT06382194)

NCT ID: NCT06382194

Last Updated: 2026-04-28

Results Overview

Data were reported on an ordinal scale (0=unlocked and loaded; 1=unlocked and unloaded; 2=locked and loaded; 3=locked and unloaded; 4=removed from house). Any improvement on the ordinal scale from baseline to follow-up was dichotomized (0=no improvement; 1=any improvement in safe firearm storage).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Assessed at 4 weeks post enrollment

Results posted on

2026-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Arm Participants in this arm will receive the intervention and undergo research assessments.
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Arm Participants in this arm will receive the intervention and undergo research assessments.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Decision Making Tool for Firearm Storage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=5 Participants Participants in this arm will receive the intervention and undergo research assessments.
Sex: Female, Male Female	4 Participants n=9 Participants
Sex: Female, Male Male	1 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants
Race (NIH/OMB) White	4 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants
Number of Participants meeting MoCA criteria for Mild Cognitive Impairment	1 participants n=9 Participants
Number with Diagnosed Depression (ICD-10 code)	5 participants n=9 Participants
Age, Customized Age 60 or older	5 Participants n=9 Participants

PRIMARY outcome

Timeframe: Assessed at 4 weeks post enrollment

Population: This is reporting the percentage of participants with an improvement in safe firearm storage.

Data were reported on an ordinal scale (0=unlocked and loaded; 1=unlocked and unloaded; 2=locked and loaded; 3=locked and unloaded; 4=removed from house). Any improvement on the ordinal scale from baseline to follow-up was dichotomized (0=no improvement; 1=any improvement in safe firearm storage).

Outcome measures

Outcome measures
Measure	Intervention Arm n=3 Participants Participants in this arm will receive the intervention and undergo research assessments.
Number of Participants With Any Improvement in Safe Firearm Storage (Adapted From the National Firearm Survey)	1 Participants

SECONDARY outcome

Timeframe: Assessed at 4 weeks post enrollment

Measured by the Low Literacy Decisional Conflict Scale. This is a 10-item scale. Response options for each item are yes (0), no (4), unsure (2). Score range is from 0 (no decisional conflict) to 40 (extremely high decisional conflict). Lower scores represent a better outcome.

Outcome measures

Outcome measures
Measure	Intervention Arm n=2 Participants Participants in this arm will receive the intervention and undergo research assessments.
Change From Baseline in the Low-Literacy Decisional Conflict Scale Score	5 score on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: Assessed at 4 weeks post enrollment

A measure of participant understanding of firearm safe storage, alternatives, rationale, risks and benefits. Each questionnaire item is given a score value of 1 (if participant correctly selects 'true' or 'false') or zero (if participant selects the incorrect answer or selects 'unsure'). Item values are totaled to obtain an overall knowledge score. Minimum score is 0 and maximum score is 8, with higher scores representing a better outcome.

Outcome measures

Outcome measures
Measure	Intervention Arm n=2 Participants Participants in this arm will receive the intervention and undergo research assessments.
Change From Baseline in Firearm Safe Storage Knowledge Questionnaire Score	-0.5 score on a scale Standard Deviation 0.7071

SECONDARY outcome

Timeframe: Assessed at 4 weeks post enrollment

Number of participants who access and report watching the decision aid intervention at follow-up

Outcome measures

Outcome measures
Measure	Intervention Arm n=3 Participants Participants in this arm will receive the intervention and undergo research assessments.
Number of Participants Who Access the Intervention	3 Participants

SECONDARY outcome

Timeframe: Assessed at 4 weeks post enrollment

A 4-item measure of the intervention's acceptability from the perspective of the participants, assessed at follow-up. The response option for each item is a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree). The score for the scale is calculated as the average of responses on the 4 items. The minimum score on the scale is 1, and the maximum score is 5. Higher scores represent a better outcome.

Outcome measures

Outcome measures
Measure	Intervention Arm n=3 Participants Participants in this arm will receive the intervention and undergo research assessments.
Mean Score on the Acceptability of Intervention Measure	3.83 score on a scale Standard Deviation 1.26

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention Arm n=5 participants at risk Participants in this arm will receive the intervention and undergo research assessments.
Injury, poisoning and procedural complications Injury related to home invasion	0.00% 0/5 • From enrollment until end of follow-up, up to 4 weeks We added avoidance of routine preventive care, increased stress from removal/reduced access to firearms, injuries related to home invasion.

Other adverse events

Other adverse events
Measure	Intervention Arm n=5 participants at risk Participants in this arm will receive the intervention and undergo research assessments.
Social circumstances Avoidance of routine primary care	0.00% 0/5 • From enrollment until end of follow-up, up to 4 weeks We added avoidance of routine preventive care, increased stress from removal/reduced access to firearms, injuries related to home invasion.
Social circumstances Increased stress from removal of firearm from the home	0.00% 0/5 • From enrollment until end of follow-up, up to 4 weeks We added avoidance of routine preventive care, increased stress from removal/reduced access to firearms, injuries related to home invasion.

Additional Information

Elizabeth Phelan or Laura Prater

University of Washington (Phelan)/ The Ohio State University (Prater)

Phone: 614-292-3218

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place