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Suicide PreventionNCT06558409

Safer Still (Exploratory Project 3)

A study testing " Safer Still " Interactive Intervention in people with Suicide Prevention, run by Jeff Bridge at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Suicide Prevention
What is being tested?
" Safer Still " Interactive Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesUnited States
Study dates
7 Nov 2024to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting
  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Nikhitha Kakarala, MPH, 6147223511, nikhitha.kakarala@nationwidechildrens.org

    Kendra Heck, MPH, 614-355-3433, kendra.heck@nationwidechildrens.org

    Not yet recruiting
  • Nationwide Children's Hospital Behavioral Health Pavillion

    Columbus, Ohio, 43215

    Director, Center for Suicide Prevention and Research, PhD- epidemiology, (614) 938-0233, Jeff.Bridge@NationwideChildrens.org

    Recruiting

Other trials in United States

About this study

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.

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.

Read the 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.

Being tested
" Safer Still " Interactive Intervention, Enhanced Usual Care (EUC):
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
Medical subject headings
Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • " Safer Still " Interactive InterventionBehavioural

    Also called Interactive intervention, Lethal means restriction, Safe storage, Firearm storage

    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):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.

Study groups in NCT06558409
Study groupRoleWhat they receive
Safer Still InterventionExperimentalInvestigators 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
Receives: Behavioral: " Safer Still " Interactive Intervention
Enhanced Usual Care (EUC)Placebo comparatorFamilies 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.
Receives: Other: Enhanced Usual Care (EUC):

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, One month and Three months

Secondary outcomes (1)
  1. Stages of Change Questionnaire (SOCQ)

    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.

    Measured: Baseline, One month, and Three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2024
  2. Study start7 Nov 2024
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06558409
Sponsor's protocol ID
STUDY00002773
Status last verified
Aug 2025
First submitted
14 Aug 2024
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification.

Publications

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

  • 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.

    PubMed 8101307
  • 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.

    PubMed 9328552
  • 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.

    PubMed 28564699
  • 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.

    PubMed 24515285
  • 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.

  • 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/

    PubMed 23136686
  • 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.

    PubMed 26864410
  • 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.

    PubMed 32497082
  • 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.

    PubMed 31697611
  • 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.

    PubMed 32995040
  • 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.

    PubMed 32826283
  • 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.

    PubMed 10939232
  • 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.

    PubMed 11474056
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing " Safer Still " Interactive Intervention in people with Suicide Prevention, run by Jeff Bridge at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nikhitha Kakarala, MPH (614-722-3511, nikhitha.kakarala@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Household Lethal Means Survey (HLMS) (time frame: Baseline, One month and Three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06558409, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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