Safer Still (Exploratory Project 3)

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.

Overview

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

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.

Interventions

• Behavioral " 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.
• Other 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 r

Primary outcome measures

• Household Lethal Means Survey (HLMS) [Time frame: Baseline, One month and Three months]

Secondary outcome measures (1)

• Stages of Change Questionnaire (SOCQ) [Time frame: Baseline, One month, and Three months]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 2 centers

• Nationwide Children's Hospital — Columbus
• Nationwide Children's Hospital Behavioral Health Pavillion — Columbus

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. PMID 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. PMID 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. PMID 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. PMID 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/ PMID 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. PMID 26864410

Identifiers

NCT: NCT06558409 · STUDY00002773

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗