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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

69 participants

Primary outcome timeframe

post-intervention (about 2 weeks after pre-intervention assessment)

Results posted on

2017-02-06

Participant Flow

Participant milestones

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

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

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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Transportation Safety

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

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

David Schwebel

University of Alabama at Birmingham

Phone: 205-934-8745

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place