Safer Still (Exploratory Project 3)

Jeff Bridge

Status: Enrolling

Conditions: Suicide Prevention

Treatments: Other: Enhanced Usual Care (EUC):; Behavioral: " Safer Still " Interactive Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06558409

STUDY00002773

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Safer Still Intervention

Experimental group

Description:

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

Treatment:

Behavioral: " Safer Still " Interactive Intervention

Enhanced Usual Care (EUC)

Placebo Comparator group

Description:

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.

Treatment:

Other: Enhanced Usual Care (EUC):