IF: Pediatric Inpatient Firearm Safety Study
Sponsor
Montefiore Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03077646
Collaborator
Everytown for Gun Safety (Other), Consano Clinical Research, LLC (Other)
225
1
3
29.3
7.7
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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:
-
Change in the primary outcome (intention to ask noted above) between the intervention groups (Be SMARTalone vs. Be SMART + MD)
-
Demographic factors associated with primary outcome
-
Description of general knowledge on firearm safety of parents/legal guardians of patients in our community
-
Description of attitudes about firearm safety of parents/legal guardians of patients in our community
-
Description of general practices regarding firearm safety of parents/legal guardians of patients in our community
-
Description of parents attitudes regarding physicians discussing firearm safety with them
Study Design
Study Type:
Interventional
Actual Enrollment
:
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pediatric Inpatient Firearm Safety Study
Actual Study Start Date
:
Mar 1, 2017
Actual Primary Completion Date
:
Aug 9, 2019
Actual Study Completion Date
:
Aug 9, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: 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
|
| Experimental: 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). |
Behavioral: 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.
|
| Active Comparator: 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). |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- 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 [Baseline and last 30 days]
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
Secondary Outcome Measures
- Doctors Who Take Care of Kids Should Talk to Parents About Safe Gun Storage at 1 Month Post-intervention [1 month after intervention]
Likert Scale Score of degree of agreement with the statement 1=strongly disagree, 2=disagree, 3=not sure, 4=agree, 5=strongly agree
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Exclusion Criteria:
-
parents/guardians whose child is hospitalized in the Pediatric Intensive Care Unit
-
parents/guardians whose child is in acute distress
-
parents/guardians who have previously been in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital at Montefiore | Bronx | New York | United States | 10467 |
Sponsors and Collaborators
- Montefiore Medical Center
- Everytown for Gun Safety
- Consano Clinical Research, LLC
Investigators
- Principal Investigator: Alyssa H Silver, MD, Children's Hospital at Montefiore-Department of Pediatrics, Division of Hospital Medicine
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Alyssa Silver,
Assistant Professor of Pediatrics, Attending Physician Pediatric Hospital Medicine,
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT03077646
Other Study ID Numbers:
- 2016-6918
First Posted:
Mar 13, 2017
Last Update Posted:
Feb 23, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alyssa Silver,
Assistant Professor of Pediatrics, Attending Physician Pediatric Hospital Medicine,
Montefiore Medical Center
Study Results
Participant Flow
| Recruitment Details | This study examine knowledge, attitudes, and practices of parents/legal guardians regarding firearm safety and tobacco smoke exposure. Children were not enrolled. |
|---|---|
| Pre-assignment Detail | The parent/guardian only was enrolled (child was not), therefore it is not a dyad. |
| Arm/Group Title | Be SMART Alone | Be SMART + MD Review | Control: TSE Materials |
|---|---|---|---|
| Arm/Group Description | 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 | 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. | 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. |
| Period Title: Overall Study | |||
| STARTED | 76 | 75 | 74 |
| COMPLETED | 47 | 45 | 43 |
| NOT COMPLETED | 29 | 30 | 31 |
Baseline Characteristics
| Arm/Group Title | Be SMART Alone | Be SMART + MD Review | Control: TSE Materials | Total |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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. | 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. | Total of all reporting groups |
| Overall Participants | 76 | 75 | 74 | 225 |
| Age (years) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [years] |
34.0
|
35.0
|
32.0
|
33.0
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
65
85.5%
|
66
88%
|
65
87.8%
|
196
87.1%
|
| Male |
11
14.5%
|
9
12%
|
9
12.2%
|
29
12.9%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| Hispanic |
39
51.3%
|
42
56%
|
45
60.8%
|
126
56%
|
| Non-Hispanic Black |
29
38.2%
|
19
25.3%
|
20
27%
|
68
30.2%
|
| Non-Hispanic White |
2
2.6%
|
3
4%
|
5
6.8%
|
10
4.4%
|
| Other |
6
7.9%
|
11
14.7%
|
4
5.4%
|
21
9.3%
|
| Child age (years), median (IQR) (years) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [years] |
4.5
|
6.0
|
4.0
|
5.0
|
| Child gender (Count of Participants) | ||||
| Male |
33
43.4%
|
48
64%
|
34
45.9%
|
115
51.1%
|
| Female |
43
56.6%
|
26
34.7%
|
40
54.1%
|
109
48.4%
|
| Missing |
0
0%
|
1
1.3%
|
0
0%
|
1
0.4%
|
| Parental education (Count of Participants) | ||||
| Elementary school |
1
1.3%
|
2
2.7%
|
2
2.7%
|
5
2.2%
|
| Some High school |
8
10.5%
|
6
8%
|
8
10.8%
|
22
9.8%
|
| High School |
34
44.7%
|
32
42.7%
|
36
48.6%
|
102
45.3%
|
| College |
28
36.8%
|
27
36%
|
23
31.1%
|
78
34.7%
|
| Graduate school |
5
6.6%
|
8
10.7%
|
5
6.8%
|
18
8%
|
| Language (Count of Participants) | ||||
| English |
73
96.1%
|
67
89.3%
|
71
95.9%
|
211
93.8%
|
| Spanish |
3
3.9%
|
6
8%
|
3
4.1%
|
12
5.3%
|
| Mixed English & Spanish |
0
0%
|
2
2.7%
|
0
0%
|
2
0.9%
|
| Insurance (Count of Participants) | ||||
| Private |
26
34.2%
|
22
29.3%
|
15
20.3%
|
63
28%
|
| Medicaid |
46
60.5%
|
49
65.3%
|
55
74.3%
|
150
66.7%
|
| None |
2
2.6%
|
0
0%
|
2
2.7%
|
4
1.8%
|
| Other |
2
2.6%
|
1
1.3%
|
0
0%
|
3
1.3%
|
| Missing |
0
0%
|
3
4%
|
2
2.7%
|
5
2.2%
|
| Seen a person with a gun? (Count of Participants) | ||||
| Count of Participants [Participants] |
23
30.3%
|
24
32%
|
18
24.3%
|
65
28.9%
|
| Heard gunshots in your neighborhood (Count of Participants) | ||||
| Count of Participants [Participants] |
51
67.1%
|
42
56%
|
42
56.8%
|
135
60%
|
| Raised in a home with a gun? (Count of Participants) | ||||
| Count of Participants [Participants] |
4
5.3%
|
8
10.7%
|
2
2.7%
|
14
6.2%
|
| Been threatened with a gun? (Count of Participants) | ||||
| Count of Participants [Participants] |
6
7.9%
|
8
10.7%
|
7
9.5%
|
21
9.3%
|
| Been shot with a gun? (Count of Participants) | ||||
| Count of Participants [Participants] |
1
1.3%
|
1
1.3%
|
1
1.4%
|
3
1.3%
|
| Have a friend/relative shot with a gun? (Count of Participants) | ||||
| Count of Participants [Participants] |
39
51.3%
|
27
36%
|
28
37.8%
|
94
41.8%
|
| Friend or relative has a gun? (Count of Participants) | ||||
| Count of Participants [Participants] |
21
27.6%
|
20
26.7%
|
18
24.3%
|
59
26.2%
|
| Child has seen a gun? (Count of Participants) | ||||
| Count of Participants [Participants] |
5
6.6%
|
6
8%
|
4
5.4%
|
15
6.7%
|
| Child has touched a gun? (Count of Participants) | ||||
| Count of Participants [Participants] |
2
2.6%
|
3
4%
|
2
2.7%
|
7
3.1%
|
| Discussed with child what to do if they find a gun? (Count of Participants) | ||||
| Count of Participants [Participants] |
19
25%
|
17
22.7%
|
17
23%
|
53
23.6%
|
| Discussed with other children what do do if they find a gun? (Count of Participants) | ||||
| Count of Participants [Participants] |
21
27.6%
|
23
30.7%
|
22
29.7%
|
66
29.3%
|
| Guns have been brought into your home by guests (Count of Participants) | ||||
| Count of Participants [Participants] |
7
9.2%
|
7
9.3%
|
5
6.8%
|
19
8.4%
|
| Have a gun in your home (Count of Participants) | ||||
| Count of Participants [Participants] |
4
5.3%
|
2
2.7%
|
2
2.7%
|
8
3.6%
|
| Worry your child would play with a gun if they find one (Count of Participants) | ||||
| Count of Participants [Participants] |
45
59.2%
|
41
54.7%
|
42
56.8%
|
128
56.9%
|
| Child's doctor has ever talked about gun safety (Count of Participants) | ||||
| Count of Participants [Participants] |
5
6.6%
|
9
12%
|
4
5.4%
|
18
8%
|
| For those who don't have a gun, you would feel safer if you had a gun (Count of Participants) | ||||
| Count of Participants [Participants] |
7
9.2%
|
7
9.3%
|
4
5.4%
|
18
8%
|
| It is important to ask about guns in others' homes when your child goes there (Likert score scale of agreement (1-5)) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Likert score scale of agreement (1-5)] |
4.4
(1)
|
4.3
(1)
|
4.4
(1)
|
4.3
(0.7)
|
Outcome Measures
| Title | 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 |
|---|---|
| Description | 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 |
| Time Frame | Baseline and last 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Limited sample for analysis to paired samples within each group (samples where we have responses from the same study subject pre and post) |
| Arm/Group Title | Be SMART Alone | Be SMART + MD Review | Control: TSE Materials |
|---|---|---|---|
| Arm/Group Description | 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 | 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. | 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. |
| Measure Participants | 25 | 27 | 20 |
| Mean (Standard Deviation) [score on a scale] |
0.8
(1.7)
|
0.6
(1.3)
|
0.9
(1.4)
|
| Title | Doctors Who Take Care of Kids Should Talk to Parents About Safe Gun Storage at 1 Month Post-intervention |
|---|---|
| Description | Likert Scale Score of degree of agreement with the statement 1=strongly disagree, 2=disagree, 3=not sure, 4=agree, 5=strongly agree |
| Time Frame | 1 month after intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some parents unable to reach by phone at 1 month |
| Arm/Group Title | Be SMART Alone | Be SMART + MD Review | Control: TSE Materials |
|---|---|---|---|
| Arm/Group Description | 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 | 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. | 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. |
| Measure Participants | 47 | 44 | 43 |
| Mean (Standard Deviation) [score on a scale] |
4.2
(0.9)
|
4.3
(0.8)
|
4.3
(0.8)
|
Adverse Events
| Time Frame | One month | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | No events reported for this educational intervemtion | |||||
| Arm/Group Title | Be SMART Alone | Be SMART + MD Review | Control: TSE Materials | |||
| Arm/Group Description | 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 | 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. | 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. | |||
All Cause Mortality |
||||||
| Be SMART Alone | Be SMART + MD Review | Control: TSE Materials | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/76 (0%) | 0/75 (0%) | 0/74 (0%) | |||
Serious Adverse Events |
||||||
| Be SMART Alone | Be SMART + MD Review | Control: TSE Materials | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/76 (0%) | 0/75 (0%) | 0/74 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Be SMART Alone | Be SMART + MD Review | Control: TSE Materials | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/76 (0%) | 0/75 (0%) | 0/74 (0%) | |||
Limitations/Caveats
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.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Alyssa Silver, MD |
|---|---|
| Organization | Children's Hospital at Montefiore |
| Phone | 718-741-2304 |
| alysilve@montefiore.org |
Responsible Party:
Alyssa Silver,
Assistant Professor of Pediatrics, Attending Physician Pediatric Hospital Medicine,
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT03077646
Other Study ID Numbers:
- 2016-6918
First Posted:
Mar 13, 2017
Last Update Posted:
Feb 23, 2021
Last Verified:
Feb 1, 2021