Safer Still (Exploratory Project 3)

NCT06558409 | Recruiting DMC

• 1 other identifier: STUDY00002773
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Household Lethal Means Survey (HLMS)

  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.

  Baseline, One month and Three months

Secondary Outcomes (1)

• Stages of Change Questionnaire (SOCQ)

  Baseline, One month, and Three months

Study Arms (2)

Safer Still Intervention

EXPERIMENTAL

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

Behavioral: " Safer Still " Interactive Intervention

Enhanced Usual Care (EUC)

PLACEBO COMPARATOR

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.

Other: Enhanced Usual Care (EUC):

Interventions

" 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.

Also known as: Interactive intervention, Lethal means restriction, Safe storage, Firearm storage, Medication storage, Behavioral economics, Suicide prevention

Safer Still Intervention

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.

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jeff Bridge: lead
• Ohio Chapter American Academy of Pediatrics: collaborator

Study Sites (2)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

NOT YET RECRUITING

Nationwide Children's Hospital Behavioral Health Pavillion

Columbus, Ohio, 43215, United States

RECRUITING

Related Publications (23)

• Prochaska JO, Norcross JC. Stages of change. Psychotherapy. 2001;38(4):443-448

  BACKGROUND

• Goldacre M, Seagroatt V, Hawton K. Suicide after discharge from psychiatric inpatient care. Lancet. 1993 Jul 31;342(8866):283-6. doi: 10.1016/0140-6736(93)91822-4.

  PMID: 8101307 BACKGROUND

• Geddes JR, Juszczak E, O'Brien F, Kendrick S. Suicide in the 12 months after discharge from psychiatric inpatient care, Scotland 1968-92. J Epidemiol Community Health. 1997 Aug;51(4):430-4. doi: 10.1136/jech.51.4.430.

  PMID: 9328552 BACKGROUND

• Chung DT, Ryan CJ, Hadzi-Pavlovic D, Singh SP, Stanton C, Large MM. Suicide Rates After Discharge From Psychiatric Facilities: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2017 Jul 1;74(7):694-702. doi: 10.1001/jamapsychiatry.2017.1044.

  PMID: 28564699 BACKGROUND

• Olfson M, Marcus SC, Bridge JA. Focusing suicide prevention on periods of high risk. JAMA. 2014 Mar 19;311(11):1107-8. doi: 10.1001/jama.2014.501. No abstract available.

  PMID: 24515285 BACKGROUND

• Centers for Disease Control and Prevention. National Center for Injury Prevention and Control. Web-based Injury Statistics Query and Reporting System (WISQARS) [online]. [Last accessed, 5/9/20]. Source of data from WISQARS is the National Vital Statistics System from the National Center for Health Statistics. Available from URL: www.cdc.gov/ncipc/wisqars. Published 2018. Accessed.

  BACKGROUND

• Office of the Surgeon General (US); National Action Alliance for Suicide Prevention (US). 2012 National Strategy for Suicide Prevention: Goals and Objectives for Action: A Report of the U.S. Surgeon General and of the National Action Alliance for Suicide Prevention. Washington (DC): US Department of Health & Human Services (US); 2012 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK109917/

  PMID: 23136686 BACKGROUND

• Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.

  PMID: 26864410 BACKGROUND

• Wang SY, Groene O. The effectiveness of behavioral economics-informed interventions on physician behavioral change: A systematic literature review. PLoS One. 2020 Jun 4;15(6):e0234149. doi: 10.1371/journal.pone.0234149. eCollection 2020.

  PMID: 32497082 BACKGROUND

• Bauer BW, Capron DW. How Behavioral Economics and Nudges Could Help Diminish Irrationality in Suicide-Related Decisions. Perspect Psychol Sci. 2020 Jan;15(1):44-61. doi: 10.1177/1745691619866463. Epub 2019 Nov 7.

  PMID: 31697611 BACKGROUND

• Davis M, Wolk CB, Jager-Hyman S, Beidas RS, Young JF, Mautone JA, Buttenheim AM, Mandell DS, Volpp KG, Wislocki K, Futterer A, Marx D, Dieckmeyer EL, Becker-Haimes EM. Implementing nudges for suicide prevention in real-world environments: project INSPIRE study protocol. Pilot Feasibility Stud. 2020 Sep 26;6:143. doi: 10.1186/s40814-020-00686-y. eCollection 2020.

  PMID: 32995040 BACKGROUND

• Horowitz LM, Wharff EA, Mournet AM, Ross AM, McBee-Strayer S, He JP, Lanzillo EC, White E, Bergdoll E, Powell DS, Solages M, Merikangas KR, Pao M, Bridge JA. Validation and Feasibility of the ASQ Among Pediatric Medical and Surgical Inpatients. Hosp Pediatr. 2020 Sep;10(9):750-757. doi: 10.1542/hpeds.2020-0087.

  PMID: 32826283 BACKGROUND

• Stiffman AR, Horwitz SM, Hoagwood K, Compton W 3rd, Cottler L, Bean DL, Narrow WE, Weisz JR. The Service Assessment for Children and Adolescents (SACA): adult and child reports. J Am Acad Child Adolesc Psychiatry. 2000 Aug;39(8):1032-9. doi: 10.1097/00004583-200008000-00019.

  PMID: 10939232 BACKGROUND

• Horwitz SM, Hoagwood K, Stiffman AR, Summerfeld T, Weisz JR, Costello EJ, Rost K, Bean DL, Cottler L, Leaf PJ, Roper M, Norquist G. Reliability of the services assessment for children and adolescents. Psychiatr Serv. 2001 Aug;52(8):1088-94. doi: 10.1176/appi.ps.52.8.1088.

  PMID: 11474056 BACKGROUND

• Bellis JM. The transtheoretical model of change applied to psychotherapy: A psychometric assessment of related instruments.: Dissertation Abstracts International, 54B, 3846. (UMI No. AAC9332421); 1994.

  BACKGROUND

• Lewis CC, Simons AD, Silva SG, Rohde P, Small DM, Murakami JL, High RR, March JS. The role of readiness to change in response to treatment of adolescent depression. J Consult Clin Psychol. 2009 Jun;77(3):422-8. doi: 10.1037/a0014154.

  PMID: 19485584 BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• Achenbach TM, Dumenci L, Rescorla LA. DSM-oriented and empirically based approaches to constructing scales from the same item pools. J Clin Child Adolesc Psychol. 2003 Sep;32(3):328-40. doi: 10.1207/S15374424JCCP3203_02.

  PMID: 12881022 BACKGROUND

• Richardson LP, McCauley E, Grossman DC, McCarty CA, Richards J, Russo JE, Rockhill C, Katon W. Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics. 2010 Dec;126(6):1117-23. doi: 10.1542/peds.2010-0852. Epub 2010 Nov 1.

  PMID: 21041282 BACKGROUND

• Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313. doi: 10.1016/0149-7189(83)90010-1.

  PMID: 10267258 BACKGROUND

• Posner K, Brent D, Lucas C, et al. Columbia-Suicide Severity Rating Scale (C-SSRS) New York State Psychiatric Institute https://cssrs.columbia.edu/wp-content/uploads/C-SSRS_Pediatric-SLC_11.14.16.pdf

  BACKGROUND

• Pierce DW. Suicidal intent in self-injury. Br J Psychiatry. 1977 Apr;130:377-85. doi: 10.1192/bjp.130.4.377.

  PMID: 870128 BACKGROUND

• Association AP. DSM-5-TR Online Assessment Measures. Accessed July 21, 2022. https://www.psychiatry.org/psychiatrists/practice/dsm/educational-resources/assessment-measures

  BACKGROUND

Related Links

• PhenX Toolkit: Mental Health Research Core Tier 1 Demographic and Social Environment Measures
• PhenX Toolkit: Suicide Specialty Collection - Access to Lethal Means Measure

MeSH Terms

Conditions

Suicide Prevention

Interventions

Economics, Behavioral

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychology; Behavioral Sciences; Behavioral Disciplines and Activities; Economics; Health Care Economics and Organizations

Study Officials

• Jeff Bridge, Ph.D.

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

• Jack Stevens, Ph.D.

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikhitha Kakarala, MPH

CONTACT

614-722-3511; nikhitha.kakarala@nationwidechildrens.org

Kendra Heck, MPH

CONTACT

614-355-3433; kendra.heck@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator: Jeffrey A Bridge, PhD,Abigail Wexner Research Institute at NCH

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: November 7, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Access Criteria: Researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Proposals should be directed tojeff.bridge@nationwidechildrens.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years after publication at a web address to be determined.

Locations

US (2)