Trial Outcomes & Findings for Pediatric Inpatient Firearm Safety Study (NCT NCT03077646)
NCT ID: NCT03077646
Last Updated: 2021-02-23
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
225 participants
Primary outcome timeframe
Baseline and last 30 days
Results posted on
2021-02-23
Participant Flow
This study examine knowledge, attitudes, and practices of parents/legal guardians regarding firearm safety and tobacco smoke exposure. Children were not enrolled.
The parent/guardian only was enrolled (child was not), therefore it is not a dyad.
Participant milestones
| Measure |
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.
|
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.
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
74
|
76
|
|
Overall Study
COMPLETED
|
45
|
43
|
47
|
|
Overall Study
NOT COMPLETED
|
30
|
31
|
29
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
30
|
31
|
29
|
Baseline Characteristics
Pediatric Inpatient Firearm Safety Study
Baseline characteristics by cohort
| Measure |
Be SMART Alone
n=76 Participants
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
|
Be SMART + MD Review
n=75 Participants
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.
|
Control: TSE Materials
n=74 Participants
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
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.0 years
n=5 Participants
|
35.0 years
n=7 Participants
|
32.0 years
n=5 Participants
|
33.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Child Race/ethnicity · Hispanic
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Child Race/ethnicity · Non-Hispanic Black
|
29 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Child Race/ethnicity · Non-Hispanic White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Child Race/ethnicity · Other
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Child age (years), median (IQR)
|
4.5 years
n=5 Participants
|
6.0 years
n=7 Participants
|
4.0 years
n=5 Participants
|
5.0 years
n=4 Participants
|
|
Child gender
Male
|
33 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Child gender
Female
|
43 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Child gender
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Parental education
Elementary school
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Parental education
Some High school
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Parental education
High School
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Parental education
College
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Parental education
Graduate school
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Language
English
|
73 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
|
Language
Spanish
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Language
Mixed English & Spanish
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Insurance
Private
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Insurance
Medicaid
|
46 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Insurance
None
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Insurance
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Insurance
Missing
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Seen a person with a gun?
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Heard gunshots in your neighborhood
|
51 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Raised in a home with a gun?
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Been threatened with a gun?
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Been shot with a gun?
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Have a friend/relative shot with a gun?
|
39 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Friend or relative has a gun?
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Child has seen a gun?
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Child has touched a gun?
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Discussed with child what to do if they find a gun?
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Discussed with other children what do do if they find a gun?
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Guns have been brought into your home by guests
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Have a gun in your home
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Worry your child would play with a gun if they find one
|
45 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Child's doctor has ever talked about gun safety
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
For those who don't have a gun, you would feel safer if you had a gun
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
It is important to ask about guns in others' homes when your child goes there
|
4.4 Likert score scale of agreement (1-5)
STANDARD_DEVIATION 1 • n=5 Participants
|
4.3 Likert score scale of agreement (1-5)
STANDARD_DEVIATION 1 • n=7 Participants
|
4.4 Likert score scale of agreement (1-5)
STANDARD_DEVIATION 1 • n=5 Participants
|
4.3 Likert score scale of agreement (1-5)
STANDARD_DEVIATION 0.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and last 30 daysPopulation: Limited sample for analysis to paired samples within each group (samples where we have responses from the same study subject pre and post)
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
Outcome measures
| Measure |
Be SMART Alone
n=25 Participants
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
|
Be SMART + MD Review
n=27 Participants
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.
|
Control: TSE Materials
n=20 Participants
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.
|
|---|---|---|---|
|
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
|
0.8 score on a scale
Standard Deviation 1.7
|
0.6 score on a scale
Standard Deviation 1.3
|
0.9 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 1 month after interventionPopulation: Some parents unable to reach by phone at 1 month
Likert Scale Score of degree of agreement with the statement 1=strongly disagree, 2=disagree, 3=not sure, 4=agree, 5=strongly agree
Outcome measures
| Measure |
Be SMART Alone
n=47 Participants
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
|
Be SMART + MD Review
n=44 Participants
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.
|
Control: TSE Materials
n=43 Participants
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.
|
|---|---|---|---|
|
Doctors Who Take Care of Kids Should Talk to Parents About Safe Gun Storage at 1 Month Post-intervention
|
4.2 score on a scale
Standard Deviation 0.9
|
4.3 score on a scale
Standard Deviation 0.8
|
4.3 score on a scale
Standard Deviation 0.8
|
Adverse Events
Be SMART Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Be SMART + MD Review
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control: TSE Materials
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place