NCT05451355

Brief Summary

Given that firearm ownership is legal, common, and valued by many people in the U.S, safe storage is important to minimize the risk of unauthorized access, injury and death. Safe storage is particularly important in households with children, as they are at elevated risk of death by unintentional injury or suicide if a gun is accessible in the home. However, only 1/3 of firearm-owning parents with children in the home report consistently safe storage. Decisions about firearm storage are complex, with perceived costs and benefits of different storage options varying by individual factors (i.e., primary reasons for firearm ownership, types of firearms), family factors (i.e., age and mental and physical health of household members), and community factors (i.e., crime and norms). Storage decisions affect all household members, and prior research finds that firearm owners who discuss storage with other family members have the safest storage practices. However, a recent survey study of firearm-owning US parents of school-aged youth (n=749) found that in only 55% of parenting dyads are both parties highly involved in the decision about how firearms are stored. In this sample, investigators observed that safe storage was more likely when both members of a parenting dyad were highly involved in the storage decision (regardless of their gender and whether one or both own firearms). However, at present firearm storage interventions are directed at individuals rather than family systems. Given the prevalence of pediatric firearm injuries and the role of within-family processes in storage safety, there is a critical need to develop a feasible, self-directed, family-centered firearm safety intervention. The objective of the proposed short-term project is to develop and obtain preliminary data about acceptability and feasibility of a prototype of a brief decision aid for parenting dyads. The conceptual framework for the decision aid is the Ottawa Decision Support Framework, and then investigators will adapt the Ottawa Person Decision Guide for Two to this issue and for self-facilitation outside of the clinical setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2022

Completed
Last Updated

December 5, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

June 24, 2022

Last Update Submit

December 1, 2022

Conditions

Keywords

FirearmsAdolescent

Outcome Measures

Primary Outcomes (2)

  • Change in communication intentions

    Parent self-report of their intentions to talk with their partner about how their household stores firearms (e.g., In the next 2 weeks, do you think that you will talk with your partner about how your household stores firearms? \[Response options: definitely no, probably no, probably yes, definitely yes\])

    Baseline, Immediately post-intervention

  • Change in planning intentions

    Parent self report of their intention to make a plan with theirpartner about storing firearms in their household more safely. (e.g., In the next 2 weeks, do you think that you will make a plan with your partner about storing firearms in your household more safely? By plan we mean having a discussion and deciding on something you are all expected to do. \[Response options: definitely no, probably no, probably yes, definitely yes\])

    Baseline, Immediately post-intervention

Secondary Outcomes (1)

  • Decision making

    Baseline, Immediately post-intervention

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants receive a link to review an educational webpage (e.g., the AAP Firearm Storage Web Page)

Behavioral: AAP Firearm Storage Web Page

Intervention Group

EXPERIMENTAL

Participants receive the newly developed prototype (e.g., the Family Safety Check In)

Behavioral: Family Safety Check-In

Interventions

Prototype decision aid to support within-family communication and decision making about firearm storage.

Intervention Group

Educational web page that discusses safe firearm storage practices.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent or guardian of at least one child under the age of 18
  • Lives with at least one other adult (e.g., romantic partner, parent)
  • Lives in the United States
  • Has at least one firearm in the home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98105, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial (RCT)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

June 24, 2022

First Posted

July 11, 2022

Study Start

July 15, 2022

Primary Completion

September 2, 2022

Study Completion

September 2, 2022

Last Updated

December 5, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations