SafetyNCT05451355
Developing a Dyadic Shared Decision Making Tool About Firearm Storage
A study testing Family Safety Check-In and AAP Firearm Storage Web Page in people with Safety, run by Seattle Children's Hospital at 1 site in United States.
Trial 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… 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 Firearm Storage Web Page
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2022to 2 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98105
About this study
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.
Read the 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.
- Conditions
- Safety
- Being tested
- Family Safety Check-In, AAP Firearm Storage Web Page
- Keywords
- Firearms, Adolescent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Safety Check-InBehavioural
Prototype decision aid to support within-family communication and decision making about firearm storage.
AAP Firearm Storage Web PageBehavioural
Educational web page that discusses safe firearm storage practices.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants receive a link to review an educational webpage (e.g., the AAP Firearm Storage Web Page) Receives: Behavioral: AAP Firearm Storage Web Page |
| Intervention Group | Experimental | Participants receive the newly developed prototype (e.g., the Family Safety Check In) Receives: Behavioral: Family Safety Check-In |
What is being measured
The primary outcome is the main question the study is designed to answer.
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])
Measured: 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])
Measured: Baseline, Immediately post-intervention
Secondary outcomes (1)
Decision making
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).
Measured: Baseline, Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start15 Jul 2022
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
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
- Model description
- Randomized controlled trial (RCT)
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
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
- NCT05451355
- Sponsor's protocol ID
- STUDY00002944
- Status last verified
- Dec 2022
- First submitted
- 24 Jun 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Dyadic Shared Decision Making Tool About Firearm Storage
- ClinicalTrials.gov ID
- NCT05451355
- Acronym / sponsor ID
- STUDY00002944
- Conditions
- Safety
- Keywords
- Firearms, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 11 Jul 2022 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: AAP Firearm Storage Web PageParticipants receive a link to review an educational webpage (e.g., the AAP Firearm Storage Web Page) |
| Intervention Group | Experimental | Behavioral: Family Safety Check-InParticipants receive the newly developed prototype (e.g., the 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 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
Key exclusion criteria (0 listed)
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-InPrototype decision aid to support within-family communication and decision making about firearm storage. | Behavioural | Intervention Group |
| AAP Firearm Storage Web PageEducational web page that discusses safe firearm storage practices. | Behavioural | Control Group |
Primary outcome
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])
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])
1 secondary outcome
Decision making
Time frame: Baseline, Immediately post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Firearm Storage Web Page 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 0 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: finished, as of the sponsor's last update on 5 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in communication intentions (time frame: Baseline, Immediately post-intervention). The study lists 2 primary outcomes in all. 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 5 Dec 2022.