Evaluating a Shared Decision-making Intervention for Families About Firearm Storage

Randomized Trial of a Shared Decision-making Intervention for Families About Firearm Storage

Investigators will conduct a randomized controlled trial assessing effectiveness of the Family Safety Check-In website on firearm storage practices. Prior to conducting the RCT, investigators will engage in a robust, participatory process of language adaptation to ensure the intervention meets the expressed needs of the large and growing proportion of parents in the United States who identify as Hispanic and speak primarily Spanish.

Study Overview

• Status: Not yet recruiting
• Conditions: Safety
• Intervention / Treatment: Behavioral: AAP Resource; Behavioral: Family Safety Check-In

Detailed Description

The clinical trial portion of this study will enroll 274 families. While two adults are required to enroll in the study for a family to participate, all adults living in the home will be invited to participate in the study. Baseline surveys will be completed by the first parent/guardian after study enrollment. Participants will then be randomized at the family-level, and, after randomization, will receive a link to their respective intervention (active control or Family Safety Check In). Survey data will also be collected 1 month and 6 months after intervention completion using self-report online questionnaires hosted on the secure REDCap platform.

• Study Type: Interventional
• Enrollment (Estimated): 548
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Kroshus; Phone Number: 206-884-5326; Email: emily.kroshus@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
      • Contact: Emily Kroshus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Parent or guardian of child aged 17 or younger
• At least two adults living in the home
• Firearms in household
• Unsafe storage practices

Exclusion Criteria:

• Not a parent or guardian
• Child is age 18 or older
• No other adults living in the home
• No firearms in household Safe storage practices

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Behavioral: Family Safety Check-In; An interactive web-based decision support tool that is tailored to different family structures and ages of children and adolescents in the home. It is designed to facilitate informed, value-consistent decision making about storage in which all adult family members are engaged in the decision-making process.
Active Comparator: Control Group	Behavioral: AAP Resource; American Academy of Pediatrics' informational resource about safe firearm storage for families.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Firearm storage practices	Adaptation of National Firearm Survey and Firearm Safety Among Children and Teens (FACTS) survey questions: Firearm storage will be measured on a continuum that reflects incremental improvements in safety across the storage of all firearms in the home.	Baseline, 1 month, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with storage practices	Satisfaction with Decision Scale: 6-item measure asking about satisfaction with received information, personal decision-making, decision-making related to value system, intent to carry out decision, sense of autonomy in decision-making, and general decision satisfaction. Responses are recorded on a 5-point scale, with higher scores indicating greater satisfaction.	Baseline, 1 month, 6 months
Feeling informed	Informed Subscale of Decisional Conflict Scale: 3-item measure assessing perceptions of feeling informed about a decision, such as knowing which options are available and knowing the risks/benefits of each option. Responses are recorded on a 5-point scale and typically converted to a 0-100 scale, where higher scores indicate higher conflict and feeling less informed.	Baseline, 1 month, 6 months
Clarity on what matters most	Values Clarity Sub-Scale of Decisional Conflict Scale: 3-item measure assessing clarity of personal values in decision-making such as being clear about which benefits and risks matter most. Responses are recorded on a 5-point scale and typically converted to a 0-100 scale, with higher scores indicating higher conflict (less clarity) about personal values for benefits and risks.	Baseline, 1 month, 6 months
Involvement in decision process	Decision Making Involvement Scale- Express subscale: 3-item measure assessing behaviors such as expressing an opinion or giving an opinion. Responses are recorded on a 4-point scale (not at all, a little bit, quite a bit, a lot), with higher scores indicating that the individual is actively participating in the decision by sharing their views.	Baseline, 1 month, 6 months
Communication quality	Lewis Mutuality and Interpersonal Sensitivity Scale: 23-item scale that measures dyadic communication. Responses are recorded on a 5-point scale, with higher scores indicating more perceived open communication.	Baseline, 1 month

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Firearms
• Other Study ID Numbers: 5R01HD116794-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in a publication, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No