Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Website to Teach Children Safety With Dogs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02299427
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
David Schwebel, University of Alabama at Birmingham

Brief Summary:

Dog bites result in over 800,000 doctor/ER visits, 6000 hospitalizations, and a dozen deaths each year in the United States. By a large margin, children suffer the highest risk - and children typically are bitten by familiar dogs in familiar places. Several programs exist to reduce pediatric dog bite risk, but few are empirically-supported or theoretically-motivated. None are widely disseminated. This study builds from existing child dog bite prevention programs to develop and then evaluate a website to teach children safe interactions with dogs. The website will be interactive, entertaining, and engaging, allowing children (target ages 4-6) to learn in a technologically-sophisticated and interactive environment. It will be developed based in behavioral theory. Hearkening child development theory, it will teach and permit practice of cognitive skills that develop in early childhood and are critical to safety with dogs: impulse control, perspective taking, and attention to details. Hearkening health behavior change theory, the website will help children and their parents perceive personal vulnerability to bites, recognize normative behavior to protect themselves, and have personal motivation to change previous habits. Overarching the website design will be goals to create an engaging and entertaining environment, and to facilitate cognitive and behavioral change on the part of both child and parent via multiple mechanisms. Besides teaching children, the website will educate parents via an innovative messaging system triggered by child attainment of points and "skill levels".

Following website development, an evaluation study will investigate usability and efficacy of the website using a repeated measures pre-test, post-test experimental design. 68 children ages 4-6 will be recruited, complete a pre-intervention assessment evaluating knowledge and behavior relevant to dog safety via multiple methods, and then be randomly assigned to use either the newly-developed dog safety website or a control pedestrian safety website at home over the subsequent 2 weeks. Frequent reminders will encourage website use. Following the 2-week period, all children will return for a post-intervention assessment battery to evaluate knowledge and behavior change. Data will be analyzed using descriptive and inferential statistics, with primary hypotheses tested using linear mixed models.


Condition or disease Intervention/treatment Phase
Child Dog Bite Prevention Behavioral: dog safety Behavioral: transportation safety Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Website to Teach Children Safety With Dogs
Study Start Date : March 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: dog safety
2 weeks of regular use of website on child dog safety developed for this research
Behavioral: dog safety
use of dog safety website at home for about 2 weeks

Active Comparator: transportation safety
2 weeks of regular use of publicly-available website on child transportation safety
Behavioral: transportation safety
use of transportation safety website at home for about 2 weeks




Primary Outcome Measures :
  1. Children's Behavior With Dogs on Standardized Objective Scale [ Time Frame: post-intervention (about 2 weeks after pre-intervention assessment) ]
    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.

  2. Simulated Behavior With Dogs on Standardized Objective Scale [ Time Frame: post-intervention (about 2 weeks after pre-intervention assessment) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • parent and child speak English,
  • exposure to dogs with some frequency,
  • internet access at home

Exclusion Criteria:

  • physical or disability preventing valid participation in study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299427


Locations
Layout table for location information
United States, Alabama
UAB Youth Safety Lab, University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Publications:
Layout table for additonal information
Responsible Party: David Schwebel, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02299427    
Other Study ID Numbers: R21HD075960 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2014    Key Record Dates
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After primary analyses will completed, will provide de-identified data to qualified users who contact us.