SafetyNCT07522112
Evaluating a Shared Decision-making Intervention for Families About Firearm Storage
A study testing Family Safety Check-In and AAP Resource in people with Safety, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- Family Safety Check-In and AAP Resource
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent or guardian of child aged 17 or younger
- At least two adults living in the home
- Firearms in household
- Unsafe storage practices
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
Emily Kroshus
About this study
Official title: 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.
Read the 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.
- Conditions
- Safety
- Being tested
- Family Safety Check-In, AAP Resource
- Keywords
- Firearms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Safety Check-InBehavioural
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.
AAP ResourceBehavioural
American Academy of Pediatrics' informational resource about safe firearm storage for families.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Behavioral: AAP Resource |
| Intervention Group | Experimental | Not described Receives: Behavioral: Family Safety Check-In |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Kroshus, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522112
- Sponsor's protocol ID
- 5R01HD116794-02
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in a publication, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Shared Decision-making Intervention for Families About Firearm Storage
- ClinicalTrials.gov ID
- NCT07522112
- Acronym / sponsor ID
- 5R01HD116794-02
- Conditions
- Safety
- Keywords
- Firearms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 548 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: AAP Resource |
| Intervention Group | Experimental | Behavioral: Family Safety Check-In |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parent or guardian of child aged 17 or younger
- At least two adults living in the home
- Firearms in household
- Unsafe storage practices
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Safety Check-InAn 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. | Behavioural | Intervention Group |
| AAP ResourceAmerican Academy of Pediatrics' informational resource about safe firearm storage for families. | Behavioural | Control Group |
Primary outcome
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.
5 secondary outcomes
Satisfaction with storage practices
Time frame: Baseline, 1 month, 6 months
Feeling informed
Time frame: Baseline, 1 month, 6 months
Clarity on what matters most
Time frame: Baseline, 1 month, 6 months
Involvement in decision process
Time frame: Baseline, 1 month, 6 months
Communication quality
Time frame: Baseline, 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in a publication, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Safety Check-In and AAP Resource in people with Safety, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Kroshus (206-884-5326, emily.kroshus@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Firearm storage practices (time frame: Baseline, 1 month, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.