- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02299427
A Website to Teach Children Safety With Dogs
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- UAB Youth Safety Lab, University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: dog safety
2 weeks of regular use of website on child dog safety developed for this research
|
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
|
use of transportation safety website at home for about 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
post-intervention (about 2 weeks after pre-intervention assessment)
|
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.
|
post-intervention (about 2 weeks after pre-intervention assessment)
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R21HD075960 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child Dog Bite Prevention
-
Queen Saovabha Memorial InstituteUnknown
-
Johns Hopkins Bloomberg School of Public HealthUniversity of Massachusetts, Lowell; Barry UniversityRecruitingChild Sexual Abuse | Program Evaluation | Perpetration of Child Sexual Abuse | Prevention InterventionUnited States
-
Queens College, The City University of New YorkState University of New York at BuffaloTerminatedParenting | Prevention | Child Maltreatment | Fathers | High-riskUnited States
-
Boston CollegeUniversity of Pennsylvania; New York University; University of the West Indies...CompletedHIV Prevention | Parent-Child Relations | Adolescent Behavior
-
Mental Health Services in the Capital Region, DenmarkTrygFonden, Denmark; Sektion for Tværsektoriel forskning - Region HovedstadenRecruitingChild | Parenting | Resilience | Mental Disorder | Prevention | FamilyDenmark
-
The University of Hong KongCompletedInjury Prevention | Internet-based Intervention | Child Safety | Anticipatory Guidance | Chinese Mothers
-
Columbia UniversityEinhorn CollaborativeSuspendedChild Development | Primary Prevention | Disruptive Behavior | Emotional ConnectionUnited States
-
University of ZimbabweNORHEDCompletedPrevention of Mother-to-child Transmission of HIVZimbabwe
-
Khon Kaen UniversityCompletedChild | Prevention | Perioperative HypotensionThailand
-
University of KwaZuluUniversity of California, San Francisco; Centers for Disease Control and Prevention and other collaboratorsCompletedEffectiveness of an HIV-adapted IMCI Training and Supervision Programme for Community Health WorkersInfant Feeding Practices | Prevention of Mother-to-child Transmission of HIV | Antenatal Health Care Utilization | Postnatal Health Care UtilizationSouth Africa
Clinical Trials on dog safety
-
Copenhagen Studies on Asthma in ChildhoodCompleted
-
University of AarhusCompletedPhysiological Stress Responses to Standardises Stress Situations | Psychological Responses to Standardised Stress Situations | Behavioural Responses to Standardised Stress SituationsDenmark
-
Swiss Tropical & Public Health InstituteUniversity of BaselCompleted
-
Indiana UniversityRecruitingAnxiety | Children | Opioid Use | Therapy DogUnited States
-
University of Maryland, BaltimoreCompletedPost Traumatic Stress DisorderUnited States
-
University of Alabama at BirminghamNot yet recruitingElbow InjuryUnited States
-
Children's Hospital Medical Center, CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development...UnknownBrain Injuries | Traumatic Brain Injury | Acquired Brain InjuryUnited States
-
University of AarhusActive, not recruitingMood | Behavior | Physiological ResponsesDenmark
-
Linkoeping UniversityMinistry of Health and Social Affairs, SwedenCompletedEpilepsy | Diabetes | Impairment
-
Cairo UniversityUnknown