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| Name | Class |
|---|---|
| Everytown for Gun Safety | OTHER_GOV |
| Consano Clinical Research, LLC | OTHER |
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There is currently no available data regarding using the inpatient setting as an opportunity to talk to parents/guardians about firearm safety. The investigators will be doing a pre-/post-intervention study to investigate the effect of an intervention (a 5.5 minute Be SMART video and written materials developed by the organization Everytown for Gun Safety), on parental/legal guardian knowledge, attitudes and practices regarding firearm safety. While the American Academy of Pediatrics recommends the safest home for children is one without guns, the reality is that there are families with guns in the home. This non-political video focuses on ways to keep children safe from firearms.
The investigators will also investigate any additional effect of physician-delivered counseling on parental/guardian knowledge, attitudes and practices regarding gun safety as compared to receiving the information solely via video and written materials.
Participants will be randomized to 1 of 3 groups (intervention, intervention + MD discussion and control group). Outcomes will be assessed immediately post intervention and in a 30-day follow up phone call.
Eligibility:
All parents/guardians of inpatients admitted to the Children's Hospital at Montefiore.
Exclusion:
Parents/guardians whose children are in acute distress or in the Pediatric Intensive Care Unit.
Outcomes:
The primary outcome is the change in parent/legal guardian's behavior over the past 30 days with respect to how often they asked whether or not there are guns in the home when their child/children goes to play in another's person's home, as indicated by a Likert scale assignment of an ordinal value (1-5, 1= never, 2=rarely, 3=sometimes, 4=most of the time, 5=always).
Secondary outcomes will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Be SMART alone | Experimental | Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information. |
|
| Be SMART + MD review | Experimental | Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information and will also have an MD review the information (via a checklist to standardize the MD review). |
|
| Control: TSE materials | Active Comparator | Parents/guardians in this study group will watch a video "Kids and Smoke Don't Mix" and receive handouts reviewing information on tobacco smoke exposure (TSE). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Be SMART | Behavioral | An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Likert Scale of Frequency of Asking About Guns in the Home When Their Child Goes to Another Person's Home, Pre-intervention and 1 Month Post-intervention | The primary outcome is within each group the change in how often the parent/guardian asked whether there are guns in the home when the child went to another person's home in the last 30 days Likert Scale 1=never, 2=rarely, 3=sometimes, 4=most of the time, 5=always | Baseline and last 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Doctors Who Take Care of Kids Should Talk to Parents About Safe Gun Storage at 1 Month Post-intervention | Likert Scale Score of degree of agreement with the statement 1=strongly disagree, 2=disagree, 3=not sure, 4=agree, 5=strongly agree | 1 month after intervention |
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Inclusion Criteria:
-
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alyssa H Silver, MD | Children's Hospital at Montefiore-Department of Pediatrics, Division of Hospital Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35112128 | Derived | Silver AH, Curley M, Azzarone G, Dodson N, O'Connor K. A Parent Survey Assessing Association of Exposure to Gun Violence, Beliefs, and Physician Counseling. Hosp Pediatr. 2022 Mar 1;12(3):e95-e111. doi: 10.1542/hpeds.2021-006050. | |
| 34162699 | Derived | Silver AH, Azzarone G, Dodson N, Curley M, Eisenberg R, Kim M, O'Connor K. A Randomized Controlled Trial for Parents of Hospitalized Children: Keeping Kids Safe From Guns. Hosp Pediatr. 2021 Jul;11(7):691-702. doi: 10.1542/hpeds.2020-001214. Epub 2021 Jun 23. |
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There is no plan to share individual participant data with other researchers. The data will only be available to study personnel approved on this study.
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The parent/guardian only was enrolled (child was not), therefore it is not a dyad.
This study examine knowledge, attitudes, and practices of parents/legal guardians regarding firearm safety and tobacco smoke exposure. Children were not enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Be SMART Alone | Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information. Be SMART: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART |
| FG001 | Be SMART + MD Review | Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information and will also have an MD review the information (via a checklist to standardize the MD review). Be SMART + MD review: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART. After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician. |
| FG002 | Control: TSE Materials | Parents/guardians in this study group will watch a video "Kids and Smoke Don't Mix" and receive handouts reviewing information on tobacco smoke exposure (TSE). Control: TSE: A video called "Kids and Smoke Don't Mix" and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Be SMART Alone | Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information. Be SMART: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Likert Scale of Frequency of Asking About Guns in the Home When Their Child Goes to Another Person's Home, Pre-intervention and 1 Month Post-intervention | The primary outcome is within each group the change in how often the parent/guardian asked whether there are guns in the home when the child went to another person's home in the last 30 days Likert Scale 1=never, 2=rarely, 3=sometimes, 4=most of the time, 5=always | Limited sample for analysis to paired samples within each group (samples where we have responses from the same study subject pre and post) | Posted | Mean | Standard Deviation | score on a scale | Baseline and last 30 days |
|
One month
No events reported for this educational intervemtion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Be SMART Alone | Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information. Be SMART: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART |
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Single center with particular "gun culture" may not be generalizable to other regions of the country.
Limited paired sample follow-up, therefore may be underpowered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alyssa Silver, MD | Children's Hospital at Montefiore | 718-741-2304 | alysilve@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2017 | Jul 17, 2020 | Prot_SAP_000.pdf |
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|
| Control: TSE | Behavioral | A video called "Kids and Smoke Don't Mix" and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line. |
|
| Be SMART + MD review | Behavioral | An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART. After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician. |
|
| BG001 | Be SMART + MD Review | Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information and will also have an MD review the information (via a checklist to standardize the MD review). Be SMART + MD review: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART. After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician. |
| BG002 | Control: TSE Materials | Parents/guardians in this study group will watch a video "Kids and Smoke Don't Mix" and receive handouts reviewing information on tobacco smoke exposure (TSE). Control: TSE: A video called "Kids and Smoke Don't Mix" and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Child age (years), median (IQR) | Median | Inter-Quartile Range | years |
|
| Child gender | Count of Participants | Participants |
|
| Parental education | Count of Participants | Participants |
|
| Language | Count of Participants | Participants |
|
| Insurance | Count of Participants | Participants |
|
| Seen a person with a gun? | Count of Participants | Participants |
|
| Heard gunshots in your neighborhood | Count of Participants | Participants |
|
| Raised in a home with a gun? | Count of Participants | Participants |
|
| Been threatened with a gun? | Count of Participants | Participants |
|
| Been shot with a gun? | Count of Participants | Participants |
|
| Have a friend/relative shot with a gun? | Count of Participants | Participants |
|
| Friend or relative has a gun? | Count of Participants | Participants |
|
| Child has seen a gun? | Count of Participants | Participants |
|
| Child has touched a gun? | Count of Participants | Participants |
|
| Discussed with child what to do if they find a gun? | Count of Participants | Participants |
|
| Discussed with other children what do do if they find a gun? | Count of Participants | Participants |
|
| Guns have been brought into your home by guests | Count of Participants | Participants |
|
| Have a gun in your home | Count of Participants | Participants |
|
| Worry your child would play with a gun if they find one | Count of Participants | Participants |
|
| Child's doctor has ever talked about gun safety | Count of Participants | Participants |
|
| For those who don't have a gun, you would feel safer if you had a gun | Count of Participants | Participants |
|
| It is important to ask about guns in others' homes when your child goes there | Mean | Standard Deviation | Likert score scale of agreement (1-5) |
|
| OG001 | Be SMART + MD Review | Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information and will also have an MD review the information (via a checklist to standardize the MD review). Be SMART + MD review: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART. After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician. |
| OG002 | Control: TSE Materials | Parents/guardians in this study group will watch a video "Kids and Smoke Don't Mix" and receive handouts reviewing information on tobacco smoke exposure (TSE). Control: TSE: A video called "Kids and Smoke Don't Mix" and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line. |
|
|
| Secondary | Doctors Who Take Care of Kids Should Talk to Parents About Safe Gun Storage at 1 Month Post-intervention | Likert Scale Score of degree of agreement with the statement 1=strongly disagree, 2=disagree, 3=not sure, 4=agree, 5=strongly agree | Some parents unable to reach by phone at 1 month | Posted | Mean | Standard Deviation | score on a scale | 1 month after intervention |
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|
| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | Be SMART + MD Review | Parents/guardians in this study group will watch a 5.5 minute Be SMART video and receive the handouts reviewing the information and will also have an MD review the information (via a checklist to standardize the MD review). Be SMART + MD review: An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART. After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician. | 0 | 75 | 0 | 75 | 0 | 75 |
| EG002 | Control: TSE Materials | Parents/guardians in this study group will watch a video "Kids and Smoke Don't Mix" and receive handouts reviewing information on tobacco smoke exposure (TSE). Control: TSE: A video called "Kids and Smoke Don't Mix" and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line. | 0 | 74 | 0 | 74 | 0 | 74 |
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