- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03835585
Gun Locks in Firearm Suicide Intervention
The Provision of Gun Locks in Lethal Means Counseling to Increase Firearm Safety in a Suicide Risk Sample
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Purpose: While psychology research and the suicide literature have not provided this evidence in a manner relevant to lethal means counseling, research across various disciplines has clearly demonstrated that providing individuals with gun locks and knowledgeable information about their proper use will significantly increase the likelihood that individuals will engage in firearm safety behaviors. The present study seeks to examine if the provision of gun locks, in addition to the current best standard interventions for suicide risk according to research, will significantly increase engagement in these behavioral outcomes.
Research Design/Method: The present study will utilize an experimental design with two groups, an experimental intervention group and a comparison intervention group. The experimental intervention group will receive the highest standard interventions (i.e., standardized full suicide risk assessment, safety planning, and lethal means counseling) in addition to a gun lock and instructional video. The comparison intervention group will receive the highest standard interventions, but will not be provided gun locks until after the study is complete.
The gun locks will be 15-inch cable locks. Locks will be mailed via USPS in envelopes upon completion of screener, if eligible for the study, but before they are scheduled to complete the first portion of the study. this will be arranged by making scheduling calls for initial sessions the day of/day after (depending on time) screeners are completed, scheduling initial sessions at least a week and a half after scheduling calls, and mailing the locks the day of scheduling calls.
Gun locks will be mailed to participants in the experimental intervention group. Data will be collected over three sessions. The first will be when baseline measures (e.g., demographics, outcomes) will be administered online, the intervention will be provided for all individuals by phone and online(only for the video instructions for lock), and post-intervention measures of outcome variables will assessed online. The 2-week follow-up interval and the 1-month interval will involve only assessment of the outcomes online. Participants in comparison intervention group will be provided gun locks after participation in the study is complete.
Research Question: Will the experimental intervention group outperform the comparison intervention group, regarding effectiveness in increasing engagement in firearm safety behaviors?
Hypothesis: The intervention for the experimental intervention group will be significantly more effective at increasing engagement in firearm safety behavior than that which will be provided for the comparison intervention group.
Data Analysis: Repeated Measures Analysis of Variance (RM-ANOVA) will be conducted, with a focus on measuring the interaction effects of Group and Time to assess whether experimental intervention group was significantly more effective than the comparison intervention group.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Florida
-
Tallahassee, Florida, Vereinigte Staaten, 32306
- Florida State University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Must own and have access to a firearm
- Must have at least one lifetime episode of suicide ideation
- Must be 18 years of age or older
Exclusion Criteria:
- May not be under 18 years of age
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Gun lock
Participants will be provided a gun lock and video instructions for its proper use, in addition to standard suicide risk interventions (i.e., standardized full suicide risk assessment, safety planning, lethal means counseling).
|
A cable-style gun lock that can be applied to a wide variety of guns for safe storage.
The application of this device to most firearms renders them impossible to use properly while the device is in place and locked.
Thorough suicide risk assessment according to guidelines established by research (Joiner et al., 1999; Chu et al., 2015).
This is used to determine the severity of suicide risk and appropriate actions to be taken.
A psychological intervention for suicide risk that is based on research (Chu et al., 2015; Stanley & Brown, 2012).
This involves listing the following on an index card: activities individuals can use to feel better during a crisis, contact numbers that are important to the individuals, emergency options that are always accessible, and reasons for living.
Although the individualized nature of safety plans does not allow for a scripted/uniform approach, for this study they will all include 8 steps and steps 5-8 (emergency options) will be the same for each individual.
A psychological intervention for suicide risk that is based on research (Bryan et al., 2011; Chu et al., 2015; Rudd, 2006; Stanley, 2018).
This involves a psychological clinician discussing, with an at-risk individual, the importance for increasing the distance/obstacles between the individual at risk for suicide and specific types of lethal means.
In the present study, the lethal means targeted was firearms and the lethal means counseling approach was able to be standardized/scripted as has been done in previous research (see Stanley, 2018).
|
Aktiver Komparator: Standard intervention
Participants will be provided standard suicide risk interventions (i.e., standardized full suicide risk assessment, safety planning, lethal means counseling) without a gun lock.
A gun lock and video instructions will be provided upon completion of the study.
|
Thorough suicide risk assessment according to guidelines established by research (Joiner et al., 1999; Chu et al., 2015).
This is used to determine the severity of suicide risk and appropriate actions to be taken.
A psychological intervention for suicide risk that is based on research (Chu et al., 2015; Stanley & Brown, 2012).
This involves listing the following on an index card: activities individuals can use to feel better during a crisis, contact numbers that are important to the individuals, emergency options that are always accessible, and reasons for living.
Although the individualized nature of safety plans does not allow for a scripted/uniform approach, for this study they will all include 8 steps and steps 5-8 (emergency options) will be the same for each individual.
A psychological intervention for suicide risk that is based on research (Bryan et al., 2011; Chu et al., 2015; Rudd, 2006; Stanley, 2018).
This involves a psychological clinician discussing, with an at-risk individual, the importance for increasing the distance/obstacles between the individual at risk for suicide and specific types of lethal means.
In the present study, the lethal means targeted was firearms and the lethal means counseling approach was able to be standardized/scripted as has been done in previous research (see Stanley, 2018).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Engagement in Firearm Safety Behaviors
Zeitfenster: Immediately prior to intervention
|
This includes a variety of actions and thinking patterns that promote safety regarding firearms.
This is measured by a self-report instrument (Engagement in Firearm Safety Behaviors; Stanley, 2018), which contains 34 items.
The items are scored on a Likert scale (i.e., 0 = Never; 1 = Sometimes, 2 = Often, 3 = Always) to gauge frequency of engagement.
16 items represent behaviors (e.g., "using a gun lock," "trading in your guns") and 18 represent thoughts (e.g., "thought about obtaining a gun lock," "thought about storing your gun unloaded.")
|
Immediately prior to intervention
|
Engagement in Firearm Safety Behaviors
Zeitfenster: Two weeks after intervention
|
This includes a variety of actions and thinking patterns that promote safety regarding firearms.
This is measured by a self-report instrument (Engagement in Firearm Safety Behaviors; Stanley, 2018), which contains 34 items.
The items are scored on a Likert scale (i.e., 0 = Never; 1 = Sometimes, 2 = Often, 3 = Always) to gauge frequency of engagement.
16 items represent behaviors (e.g., "using a gun lock," "trading in your guns") and 18 represent thoughts (e.g., "thought about obtaining a gun lock," "thought about storing your gun unloaded.")
|
Two weeks after intervention
|
Engagement in Firearm Safety Behaviors
Zeitfenster: One month after intervention
|
This includes a variety of actions and thinking patterns that promote safety regarding firearms.
This is measured by a self-report instrument (Engagement in Firearm Safety Behaviors; Stanley, 2018), which contains 34 items.
The items are scored on a Likert scale (i.e., 0 = Never; 1 = Sometimes, 2 = Often, 3 = Always) to gauge frequency of engagement.
16 items represent behaviors (e.g., "using a gun lock," "trading in your guns") and 18 represent thoughts (e.g., "thought about obtaining a gun lock," "thought about storing your gun unloaded.")
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One month after intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Intentions to Adhere to Clinician Recommendations
Zeitfenster: Immediately prior to Intervention
|
A structured self-report questionnaire utilized in previous research (Stanley et al., 2017; Stanley, 2018) will be used in the present study to assess participants' intentions to adhere to clinician recommendations to limit access to a firearm for safety purposes.
The two items will be rated on a 10-point Likert type scale (1 = Not At All Likely; 10 = Very Likely) and they will read as follows: 1) "How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?";
and 2) "How likely would you be to encourage a loved one to adhere to your clinician's recommendations to limit their access to a firearm for safety purposes?"
|
Immediately prior to Intervention
|
Intentions to Adhere to Clinician Recommendations
Zeitfenster: Immediately after intervention
|
A structured self-report questionnaire utilized in previous research (Stanley et al., 2017; Stanley, 2018) will be used in the present study to assess participants' intentions to adhere to clinician recommendations to limit access to a firearm for safety purposes.
The two items will be rated on a 10-point Likert type scale (1 = Not At All Likely; 10 = Very Likely) and they will read as follows: 1) "How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?";
and 2) "How likely would you be to encourage a loved one to adhere to your clinician's recommendations to limit their access to a firearm for safety purposes?"
|
Immediately after intervention
|
Intentions to Adhere to Clinician Recommendations
Zeitfenster: Two weeks after intervention
|
A structured self-report questionnaire utilized in previous research (Stanley et al., 2017; Stanley, 2018) will be used in the present study to assess participants' intentions to adhere to clinician recommendations to limit access to a firearm for safety purposes.
The two items will be rated on a 10-point Likert type scale (1 = Not At All Likely; 10 = Very Likely) and they will read as follows: 1) "How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?";
and 2) "How likely would you be to encourage a loved one to adhere to your clinician's recommendations to limit their access to a firearm for safety purposes?"
|
Two weeks after intervention
|
Intentions to Adhere to Clinician Recommendations
Zeitfenster: One month after intervention
|
A structured self-report questionnaire utilized in previous research (Stanley et al., 2017; Stanley, 2018) will be used in the present study to assess participants' intentions to adhere to clinician recommendations to limit access to a firearm for safety purposes.
The two items will be rated on a 10-point Likert type scale (1 = Not At All Likely; 10 = Very Likely) and they will read as follows: 1) "How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?";
and 2) "How likely would you be to encourage a loved one to adhere to your clinician's recommendations to limit their access to a firearm for safety purposes?"
|
One month after intervention
|
Acceptability of Intervention
Zeitfenster: Immediately prior to intervention
|
The acceptability of the intervention will be measured utilizing the Client Satisfaction Questionnaire-8 (CSQ-8).
The CSQ-8 is an 8-item instrument assessing the degree to which individuals find services to be acceptable (Attkisson & Zwick, 1982; Larsen et al., 1979).
Items are rated in Likert type scales ranging from 1 to 4 (e.g., 1 = Quite dissatisfied, 2 = indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied).
The measure utilizes a summed score (range: 8-32), with higher values being indicative of higher levels of acceptability for the services received by respondents.
Items cover a broad array of acceptability standards (e.g., "How satisfied are you with the amount of help you received?",
"Have the services you received helped you to deal more effectively with your problems?").
|
Immediately prior to intervention
|
Acceptability of Intervention
Zeitfenster: Immediately after intervention
|
The acceptability of the intervention will be measured utilizing the Client Satisfaction Questionnaire-8 (CSQ-8).
The CSQ-8 is an 8-item instrument assessing the degree to which individuals find services to be acceptable (Attkisson & Zwick, 1982; Larsen et al., 1979).
Items are rated in Likert type scales ranging from 1 to 4 (e.g., 1 = Quite dissatisfied, 2 = indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied).
The measure utilizes a summed score (range: 8-32), with higher values being indicative of higher levels of acceptability for the services received by respondents.
Items cover a broad array of acceptability standards (e.g., "How satisfied are you with the amount of help you received?",
"Have the services you received helped you to deal more effectively with your problems?").
|
Immediately after intervention
|
Acceptability of Intervention
Zeitfenster: Two weeks after intervention
|
The acceptability of the intervention will be measured utilizing the Client Satisfaction Questionnaire-8 (CSQ-8).
The CSQ-8 is an 8-item instrument assessing the degree to which individuals find services to be acceptable (Attkisson & Zwick, 1982; Larsen et al., 1979).
Items are rated in Likert type scales ranging from 1 to 4 (e.g., 1 = Quite dissatisfied, 2 = indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied).
The measure utilizes a summed score (range: 8-32), with higher values being indicative of higher levels of acceptability for the services received by respondents.
Items cover a broad array of acceptability standards (e.g., "How satisfied are you with the amount of help you received?",
"Have the services you received helped you to deal more effectively with your problems?").
|
Two weeks after intervention
|
Acceptability of Intervention
Zeitfenster: One month after intervention
|
The acceptability of the intervention will be measured utilizing the Client Satisfaction Questionnaire-8 (CSQ-8).
The CSQ-8 is an 8-item instrument assessing the degree to which individuals find services to be acceptable (Attkisson & Zwick, 1982; Larsen et al., 1979).
Items are rated in Likert type scales ranging from 1 to 4 (e.g., 1 = Quite dissatisfied, 2 = indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied).
The measure utilizes a summed score (range: 8-32), with higher values being indicative of higher levels of acceptability for the services received by respondents.
Items cover a broad array of acceptability standards (e.g., "How satisfied are you with the amount of help you received?",
"Have the services you received helped you to deal more effectively with your problems?").
|
One month after intervention
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Thomas E Joiner, PhD, Robert O. Lawton Distinguished Professor
- Hauptermittler: Bruno Chiurliza, MS, graduate student
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HSC#: 2018.26057
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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