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Not yet recruiting NCT07522112

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

No phase Interventional Safety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Family Safety Check-In, AAP Resource.
Who it may be relevant to
Registry conditions: Safety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.
  • Behavioral AAP Resource
    American Academy of Pediatrics' informational resource about safe firearm storage for families.

Primary outcome measures

  • Firearm storage practices [Time frame: Baseline, 1 month, 6 months]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Seattle Children's Hospital — Seattle

Identifiers

NCT: NCT07522112 · 5R01HD116794-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗