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

April 13, 2026 updated by: Emily Kroshus, Seattle Children's Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
548

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Firearm storage practices
Time Frame: Baseline, 1 month, 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction with storage practices
Time Frame: Baseline, 1 month, 6 months
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
Time Frame: Baseline, 1 month, 6 months
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
Time Frame: Baseline, 1 month, 6 months
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
Time Frame: Baseline, 1 month, 6 months
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
Time Frame: Baseline, 1 month
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seattle Children's Hospital

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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