Safer Still (Exploratory Project 3)

NCT ID: NCT06558409

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-07

Study Completion Date

2027-07-31

Brief Summary

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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

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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.

Conditions

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Suicide Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Safer Still Intervention

Investigators will present parents with suggested alternatives for restricting lethal means, particularly firearms and medications with high toxicity in overdose. Investigators will present multiple options for restricting access as opposed to just one alternative that may be deemed unreasonable by a family. Investigators will generate these options based upon the expertise of the study's lethal means consultant. Second, the mobile technology platform will provide weekly prompts about means restriction. Parents who have not restricted access to lethal means will be asked to document their reasons for inaction-a justification for not following safe storage practices. Third, the mobile technology platform will provide descriptive normative data regarding means restriction to those who have not secured these items

Group Type EXPERIMENTAL

" Safer Still " Interactive Intervention

Intervention Type BEHAVIORAL

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

Enhanced 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. 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.

Group Type PLACEBO_COMPARATOR

Enhanced Usual Care (EUC):

Intervention Type 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.

Interventions

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" 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.

Intervention Type BEHAVIORAL

Enhanced 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.

Intervention Type OTHER

Other Intervention Names

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Interactive intervention Lethal means restriction Safe storage Firearm storage Medication storage Behavioral economics Suicide prevention

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio Chapter American Academy of Pediatrics

OTHER

Sponsor Role collaborator

Jeff Bridge

OTHER

Sponsor Role lead

Responsible Party

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Jeff Bridge

Principal Investigator: Jeffrey A Bridge, PhD,Abigail Wexner Research Institute at NCH

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jeff Bridge, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Jack Stevens, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status NOT_YET_RECRUITING

Nationwide Children's Hospital Behavioral Health Pavillion

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nikhitha Kakarala, MPH

Role: CONTACT

614-722-3511

Kendra Heck, MPH

Role: CONTACT

614-355-3433

Facility Contacts

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Nikhitha Kakarala, MPH

Role: primary

6147223511

Kendra Heck, MPH

Role: backup

614-355-3433

Director, Center for Suicide Prevention and Research, PhD- epidemiology

Role: primary

(614) 938-0233

References

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Related Links

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https://www.phenxtoolkit.org/sub-collections/view/1

PhenX Toolkit: Mental Health Research Core Tier 1 Demographic and Social Environment Measures

https://www.phenxtoolkit.org/toolkit/?add[]=641001

PhenX Toolkit: Suicide Specialty Collection - Access to Lethal Means Measure

Other Identifiers

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STUDY00002773

Identifier Type: -

Identifier Source: org_study_id

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