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| Name | Class |
|---|---|
| Ohio Chapter American Academy of Pediatrics | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| " 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikhitha Kakarala, MPH | Contact | 614-722-3511 | nikhitha.kakarala@nationwidechildrens.org | |
| Kendra Heck, MPH | Contact | 614-355-3433 | kendra.heck@nationwidechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Jeff Bridge, Ph.D. | Nationwide Children's Hospital | Principal Investigator |
| Jack Stevens, Ph.D. | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Not yet recruiting | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Prochaska JO, Norcross JC. Stages of change. Psychotherapy. 2001;38(4):443-448 | ||
| 8101307 | 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. | |
| 9328552 |
| Label | URL |
|---|---|
| PhenX Toolkit: Mental Health Research Core Tier 1 Demographic and Social Environment Measures | View source |
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All of the individual participant data collected during the trial, after deidentification.
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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.
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| ID | Term |
|---|---|
| D000092864 | Suicide Prevention |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D060909 | Economics, Behavioral |
| ID | Term |
|---|---|
| D011584 | Psychology |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D004467 | Economics |
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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.
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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.
|
| 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. |
|
| Baseline, One month, and Three months |
| Nationwide Children's Hospital Behavioral Health Pavillion | Recruiting | Columbus | Ohio | 43215 | United States |
|
| 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. |
| 28564699 | 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. |
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| 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. |
| 23136686 | 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/ |
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| 32497082 | 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. |
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| Background | Association AP. DSM-5-TR Online Assessment Measures. Accessed July 21, 2022. https://www.psychiatry.org/psychiatrists/practice/dsm/educational-resources/assessment-measures |
| PhenX Toolkit: Suicide Specialty Collection - Access to Lethal Means Measure | View source |
| D004472 |
| Health Care Economics and Organizations |