Child Dog Bite PreventionPhase 1NCT02299427
A Website to Teach Children Safety With Dogs
A Phase 1 study testing dog safety and transportation safety in people with Child Dog Bite Prevention, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Dog Bite Prevention
- What is being tested?
- dog safety and transportation safety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jan 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- parent and child speak English,
- exposure to dogs with some frequency,
- internet access at home
Who cannot join
- physical or disability preventing valid participation in study
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Youth Safety Lab, University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
- Conditions
- Child Dog Bite Prevention
- Being tested
- dog safety, transportation safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dog safetyBehavioural
use of dog safety website at home for about 2 weeks
transportation safetyBehavioural
use of transportation safety website at home for about 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| dog safety | Experimental | 2 weeks of regular use of website on child dog safety developed for this research Receives: Behavioral: dog safety |
| transportation safety | Active comparator | 2 weeks of regular use of publicly-available website on child transportation safety Receives: Behavioral: transportation safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Behavior With Dogs on Standardized Objective Scale
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.
Measured: post-intervention (about 2 weeks after pre-intervention assessment)
Simulated Behavior With Dogs on Standardized Objective Scale
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.
Measured: post-intervention (about 2 weeks after pre-intervention assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Dog Bite PreventionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Schwebel, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299427
- Sponsor's protocol ID
- R21HD075960
- Status last verified
- Dec 2016
- First submitted
- 18 Nov 2014
- Last updated
- 6 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: After primary analyses will completed, will provide de-identified data to qualified users who contact us.
Publications
Schwebel DC, McClure LA, Severson J. Evaluating a website to teach children safety with dogs. Inj Prev. 2015 Feb;21(1):e2. doi: 10.1136/injuryprev-2014-041286. Epub 2014 May 28.
PubMed 24871960
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Website to Teach Children Safety With Dogs
- ClinicalTrials.gov ID
- NCT02299427
- Acronym / sponsor ID
- R21HD075960
- Conditions
- Child Dog Bite Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 6 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dog safety | Experimental | Behavioral: dog safety2 weeks of regular use of website on child dog safety developed for this research |
| transportation safety | Active comparator | Behavioral: transportation safety2 weeks of regular use of publicly-available website on child transportation safety |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- parent and child speak English,
- exposure to dogs with some frequency,
- internet access at home
Key exclusion criteria (1 listed)
- physical or disability preventing valid participation in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dog safetyuse of dog safety website at home for about 2 weeks | Behavioural | dog safety |
| transportation safetyuse of transportation safety website at home for about 2 weeks | Behavioural | transportation safety |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24871960Schwebel DC, McClure LA, Severson J. Evaluating a website to teach children safety with dogs. Inj Prev. 2015 Feb;21(1):e2. doi: 10.1136/injuryprev-2014-041286. Epub 2014 May 28.
- Individual participant dataSharing planned: Undecided. After primary analyses will completed, will provide de-identified data to qualified users who contact us.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dog safety and transportation safety in people with Child Dog Bite Prevention, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Behavior With Dogs on Standardized Objective Scale (time frame: post-intervention (about 2 weeks after pre-intervention assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02299427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.