Trial Outcomes & Findings for A Website to Teach Children Safety With Dogs (NCT NCT02299427)
NCT ID: NCT02299427
Last Updated: 2017-02-06
Results Overview
Coded behavior using objective criteria during a semi-structured interaction with a live therapy dog. Specifically, we examined behavioral patterns for 15 tasks/activities/decisions the child made with the live dog. Sample tasks were when and how the child touched the dog, the extent to which the child was close or intimate to the dog, whether the child handled the dog's toys, and whether the child interrupted the dog during its "rest time". 7 of those hung together in factor analysis. Those 7 were standardized and then averaged to create the scale. It was transformed with linear transformation so all values are positive. Higher numbers indicate higher risk-taking. Theoretically the scale is 0-infinity; in practice most children scored between 0-4. The individual items had an average intercorrelation of .50 and Cronbach's alpha of .65.
COMPLETED
PHASE1
69 participants
post-intervention (about 2 weeks after pre-intervention assessment)
2017-02-06
Participant Flow
Participant milestones
| Measure |
Dog Safety
2 weeks of regular use of website on child dog safety developed for this research
dog safety: use of dog safety website at home for about 2 weeks
|
Transportation Safety
2 weeks of regular use of publicly-available website on child transportation safety
transportation safety: use of transportation safety website at home for about 2 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
|
Overall Study
COMPLETED
|
12
|
31
|
|
Overall Study
NOT COMPLETED
|
23
|
3
|
Reasons for withdrawal
| Measure |
Dog Safety
2 weeks of regular use of website on child dog safety developed for this research
dog safety: use of dog safety website at home for about 2 weeks
|
Transportation Safety
2 weeks of regular use of publicly-available website on child transportation safety
transportation safety: use of transportation safety website at home for about 2 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
not adherent to dog website use
|
21
|
0
|
Baseline Characteristics
A Website to Teach Children Safety With Dogs
Baseline characteristics by cohort
| Measure |
Dog Safety
n=35 Participants
2 weeks of regular use of website on child dog safety developed for this research
dog safety: use of dog safety website at home for about 2 weeks
|
Transportation Safety
n=34 Participants
2 weeks of regular use of publicly-available website on child transportation safety
transportation safety: use of transportation safety website at home for about 2 weeks
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.0 years
STANDARD_DEVIATION 0.6 • n=99 Participants
|
5.1 years
STANDARD_DEVIATION 0.6 • n=107 Participants
|
5.1 years
STANDARD_DEVIATION .6 • n=206 Participants
|
|
Gender
Female
|
14 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Gender
Male
|
21 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 participants
n=99 Participants
|
10 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
27 participants
n=99 Participants
|
19 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
34 participants
n=107 Participants
|
69 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: post-intervention (about 2 weeks after pre-intervention assessment)Population: In the dog safety group, only children with known noncompliance were analyzed for this measure
Coded behavior using objective criteria during a semi-structured interaction with a live therapy dog. Specifically, we examined behavioral patterns for 15 tasks/activities/decisions the child made with the live dog. Sample tasks were when and how the child touched the dog, the extent to which the child was close or intimate to the dog, whether the child handled the dog's toys, and whether the child interrupted the dog during its "rest time". 7 of those hung together in factor analysis. Those 7 were standardized and then averaged to create the scale. It was transformed with linear transformation so all values are positive. Higher numbers indicate higher risk-taking. Theoretically the scale is 0-infinity; in practice most children scored between 0-4. The individual items had an average intercorrelation of .50 and Cronbach's alpha of .65.
Outcome measures
| Measure |
Dog Safety
n=12 Participants
2 weeks of regular use of website on child dog safety developed for this research
dog safety: use of dog safety website at home for about 2 weeks
|
Transportation Safety
n=34 Participants
2 weeks of regular use of publicly-available website on child transportation safety
transportation safety: use of transportation safety website at home for about 2 weeks
|
|---|---|---|
|
Children's Behavior With Dogs on Standardized Objective Scale
|
1.4 units on a scale
Standard Deviation .5
|
1.6 units on a scale
Standard Deviation .8
|
PRIMARY outcome
Timeframe: post-intervention (about 2 weeks after pre-intervention assessment)Population: In the dog safety group, only children with known noncompliance were analyzed for this measure
Coded behavior in dollhouse simulation. Specifically, in 7 simulated scenarios using a dollhouse that included child and dog characters, furniture, yard, etc., children heard a scene and explained/used the dolls to act what would happen next. For example, the experimenter acted a child doll playing in the kitchen near dog food and the doll dog entered, saw the child, and approached the food bowl. The experimenter said, "\[Child's Name\] is playing around in the kitchen near \[Dog name's\] food. \[Dog's name\] comes into the kitchen and sees \[Child's Name\] near his/her food bowl making him/her upset and start to growl. What will happen next?" The task was coded using objective coding criteria to score the child's response as safe (1 point), safe but not optimal (0.5 points), or unsafe (0 points). Scores across the 7 scenarios were summed to yield a single score; possible range = 0=7. Higher scores indicate better safety. Inter-rater reliability on 30% of the sample was good; kappa = .90.
Outcome measures
| Measure |
Dog Safety
n=12 Participants
2 weeks of regular use of website on child dog safety developed for this research
dog safety: use of dog safety website at home for about 2 weeks
|
Transportation Safety
n=34 Participants
2 weeks of regular use of publicly-available website on child transportation safety
transportation safety: use of transportation safety website at home for about 2 weeks
|
|---|---|---|
|
Simulated Behavior With Dogs on Standardized Objective Scale
|
3.0 units on a scale
Standard Deviation 2.0
|
3.6 units on a scale
Standard Deviation 2.1
|
Adverse Events
Dog Safety
Transportation Safety
Serious adverse events
| Measure |
Dog Safety
n=35 participants at risk
2 weeks of regular use of website on child dog safety developed for this research
dog safety: use of dog safety website at home for about 2 weeks
There is a discrepancy in participants at risk compared to the participant flow module because some children were not compliant to the intervention. They did not use the internet website and therefore were excluded from analyses. They did not have adverse events; they merely were not exposed to the intervention and therefore were excluded from analysis.
|
Transportation Safety
n=34 participants at risk
2 weeks of regular use of publicly-available website on child transportation safety
transportation safety: use of transportation safety website at home for about 2 weeks
|
|---|---|---|
|
Social circumstances
adverse medical or social situations
|
0.00%
0/35
|
0.00%
0/34
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place