Clinical trial NCT06558409: Safer Still (Exploratory Project 3)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Ohio Chapter American Academy of Pediatrics
First posted: 2024-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Household Lethal Means Survey (HLMS)
timeFrame: Baseline, One month and Three months
Secondary outcomes:
measure: Stages of Change Questionnaire (SOCQ)
timeFrame: Baseline, One month, and Three months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital Behavioral Health Pavillion
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Jeff Bridge, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital
name: Jack Stevens, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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