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Safer Still (Exploratory Project 3)

Safer Still (EP3)- An Interactive Intervention Adjunct to Traditional Care for Adolescents Who Are Discharged From Psychiatric Hospitals and Living in Households Where Firearms Are Stored Unsafely.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06558409
Enrollment
80
Registered
2024-08-16
Start date
2024-11-07
Completion date
2027-07-31
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide Prevention

Keywords

Firearms safety, Lethal means prevention, Safe storage of firearms and medication, Mobile application, Interactive intervention, Firearm storage behavior, Behavioral economics, Behavioral nudges, Lethal means restriction, Medication storage practices

Brief summary

The long-term goal is to decrease suicide and suicidal behaviors in at-risk youth through preventative interventions. Investigators propose to develop an interactive intervention (Safer Still) to help promote safe storage of firearms during the critical period immediately following high-risk care transitions. The objective of this study is to develop and test the Safer Still intervention as an efficient adjunct to traditional care for adolescents aged 12-17 years who are discharged from psychiatric hospitals and living in households where firearms are stored unsafely.

Detailed description

The objective of this study is to develop and test the Safer Still intervention as an efficient adjunct to traditional care for adolescents aged 12-17 years who are discharged from psychiatric hospitals and living in households where firearms are stored unsafely. Exploratory aims of the study are as follows: (1) Evaluate parental motivation to change firearm storage behavior as a potential mediator of the three-month intervention effect. Investigators hypothesize that higher change scores in the action stage of the readiness to change model1 at one month will mediate the intervention effect at three months; (2) Identify whether the response to the Safer Still intervention varies by adolescent history of suicide attempt and parental primary reason for firearm ownership at one and three months; and (3) Ascertain common parental reasons for declining to safely store firearms.

Interventions

BEHAVIORAL Safer Still Interactive Intervention

An interactive intervention will be developed to help promote safe storage of firearms during the critical period immediately following high-risk care transitions.

OTHEREnhanced Usual Care (EUC):

Families randomly assigned to the control condition will receive a psychological placebo that will feature an education only website developed by NCH's web design team. This website will cover warning signs for suicide, the leading methods of suicide - so that both conditions have content that features information about firearms - and locating professional help. The control website will NOT feature these three behavioral economic strategies--namely (a) multiple suggested alternatives for means restriction, (b) requests to justify inaction regarding means restriction, and (c) normative feedback about means restriction.

Sponsors

Ohio Chapter American Academy of Pediatrics
CollaboratorOTHER
Jeff Bridge
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Like the intervention Safer Still web-based program, the control website will be branded with a Nationwide Children's Hospital affiliation, as opposed to an outside organization that will be less familiar to the central Ohio sample. The control website will NOT feature these three behavioral economic strategies--namely (a) multiple suggested alternatives for means restriction, (b) requests to justify inaction regarding means restriction, and (c) normative feedback about means restriction.

Intervention model description

80 families will be randomly assigned to either the Safer Still intervention (n=40) or EUC (n=40) in a parallel groups design. A stratified randomization procedure will balance the groups of participating parents on recruitment site.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Parent or legal guardian of an adolescent aged 12 to 17 years at time of consent * Have a child who is receiving psychiatric inpatient, crisis, or emergency treatment at Nationwide Children's Hospital * Indicate that at least one firearm is located in or around the residence of the adolescent and is stored unlocked, loaded, or both unlocked and loaded. * Only one parent per household is permitted to participate to avoid contamination across the two study conditions.

Exclusion criteria

* Inability to speak/read English * Lack access to a digital device (smartphone, iPad, tablet computer, desktop, laptop PC).

Design outcomes

Primary

MeasureTime frameDescription
Household Lethal Means Survey (HLMS)Baseline, One month and Three monthsThe Household Lethal Means Survey (HLMS) asks the parent to indicate whether there are any guns kept in or around the home, and if so to describe how the gun(s) and ammunition are stored. The HLMS will be supplemented with three questions from the 2018 California Safety and Well-Being Survey. These three questions address reasons for firearm ownership, loaded handgun carrying in the past 30 days, and high-capacity magazine ownership. At follow-up, the study survey assesses whether and how firearm ownership and storage practices changed since baseline. Similar questions at baseline and follow-up are asked about lethal medications.

Secondary

MeasureTime frameDescription
Stages of Change Questionnaire (SOCQ)Baseline, One month, and Three monthsReadiness to change firearm and medication storage practices will be assessed using the Stages of Change Questionnaire (SOCQ), a psychometrically sound 12-item self-report measure ( 5-point Likert scale; -2 = Strongly Disagree; +2 = Strongly Agree). The scale will be used to measure the four stages of change (Pre-contemplation, Contemplation, Action, and Maintenance). Items numbered 1,3,6,10 Precontemplation, items numbered 2,4,7,11 = Contemplation and items numbered 5,8,9,12 = Action. A negative scale score reflects an overall disagreement with items measuring the stage of change, whereas a positive score represents overall agreement. The highest scale score represents the Stage of Change Designation.

Countries

United States

Contacts

Primary ContactNikhitha Kakarala, MPH
nikhitha.kakarala@nationwidechildrens.org614-722-3511
Backup ContactKendra Heck, MPH
kendra.heck@nationwidechildrens.org614-355-3433

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026