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NCT Number: NCT06558409

Safer Still (Exploratory Project 3)

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital, Columbus, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

" Safer Still " Interactive Intervention

Behavioral

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

Other names: Interactive intervention, Lethal means restriction, Safe storage, Firearm storage, Medication storage, Behavioral economics, Suicide prevention

Enhanced Usual Care (EUC):

Other

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.

Primary outcomes

  1. Household Lethal Means Survey (HLMS)

    Time frame: Baseline, One month and Three months

    The 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 outcomes

  1. Stages of Change Questionnaire (SOCQ)

    Time frame: Baseline, One month, and Three months

    Readiness 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kendra Heck, MPH

CONTACT

[email protected]

614-355-3433

Nikhitha Kakarala, MPH

CONTACT

[email protected]

614-722-3511

Sponsors and collaborators

Lead sponsor

Jeff Bridge

Other

Collaborators

  • Ohio Chapter American Academy of Pediatrics

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 16, 2024
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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