Developing a Dyadic Shared Decision Making Tool About Firearm Storage

December 1, 2022 updated by: Emily Kroshus, Seattle Children's Hospital

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.

Study Overview

Detailed Description

Investigators will recruit up to 400 individuals who meet the following eligibility criteria: 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, and has at least one firearm in the home. Participants will be recruited using a Qualtrics survey panel with demographic screening questions to generate a sample of eligible individuals.

Parents will access a link to a web-based survey platform (e.g., Qualtrics) and complete a series of survey questions, they will then be randomized to view either (1) the Family Safety Check-In (intervention) or (2) the AAP Firearm Storage web page (active control). All participants will then complete the same series of additional survey questions.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Participants receive a link to review an educational webpage (e.g., the AAP Firearm Storage Web Page)
Educational web page that discusses safe firearm storage practices.
Experimental: Intervention Group
Participants receive the newly developed prototype (e.g., the Family Safety Check In)
Prototype decision aid to support within-family communication and decision making about firearm storage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in communication intentions
Time Frame: Baseline, Immediately post-intervention
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
Time Frame: Baseline, Immediately post-intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision making
Time Frame: Baseline, Immediately post-intervention
Self-report scales of parent how parent feels about making decisions about firearm storage (feeling informed about risks, clarity on what matters most, perceived benefits and barriers of shared decision making).
Baseline, Immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Actual)

September 2, 2022

Study Completion (Actual)

September 2, 2022

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00002944

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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