Child Passenger SafetyNCT02720289
Video-Based Social Learning or Didactics for Car Seat Education
A study testing Video-based social learning class and Traditional didactic class in people with Child Passenger Safety, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
This study compares a video-based social learning method to the traditional didactic method as a new way to teach caregivers about child passenger safety, including how to install a car seat. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Child Passenger Safety
- What is being tested?
- Video-based social learning class and Traditional didactic class
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents or caregivers of car seat-age children (age zero to three years)
- Participation in the Kids Ride Safe Program
Who cannot join
- Spoke a language other than English or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Car Seat Education: What Works Best?
This study compares a video-based social learning method to the traditional didactic method as a new way to teach caregivers about child passenger safety, including how to install a car seat. Half of the caregivers will attend the video-based social learning class, while the other half will attend the traditional didactic class. The investigators hypothesize that the video-based social learning method will lead to an equal or greater increase in caregiver child passenger safety proficiency when compared to the traditional didactic method.
Read the detailed description
Previous studies have demonstrated the effectiveness of child passenger safety education, however, there is limited research identifying an optimal teaching method.
Social learning teaching methods are beneficial in promoting health-behavior change. The social learning theory hypothesizes that people learn and change their behavior by observation and modeling. The video used in the social learning method shows parents as role models methodically teaching proper car seat installation in a vehicle.
Traditionally, child passenger safety education classes are didactic in design, relying on lecture formats and live demonstrations. The didactic method includes verbal instructions from a child passenger safety technician about car seat installation.
- Conditions
- Child Passenger Safety
- Being tested
- Video-based social learning class, Traditional didactic class
- Keywords
- injury prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based social learning classOther
Brief child passenger safety lecture by a child passenger safety technician and viewing of a car seat video.
Traditional didactic classOther
Child passenger safety lecture by a child passenger safety technician.
| Study group | Role | What they receive |
|---|---|---|
| Video-based social learning | Experimental | Video-based social learning class Receives: Other: Video-based social learning class |
| Traditional didactic | Active comparator | Traditional didactic class Receives: Other: Traditional didactic class |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-Item Car Seat Installation Demonstration Measure
Each participant will install a car seat in their vehicle prior to, and immediately following, the intervention. A child passenger safety technician observing the installation and blinded to the intervention, will use this measure to evaluate the 5 areas of installation: direction, location, mechanism (seatbelt or lower anchors), harness position, and tether use. Participants will only be evaluated on installation demonstration areas relevant to their vehicle and car seat. Each item is scored correct or incorrect. Correct car seat installation is defined as all applicable items marked correct.
Measured: 30 minutes
Secondary outcomes (2)
5-Item Confidence in Car Seat Installation Ability Assessment
Self reported confidence in ability to correctly install a car seat with one question each for the 5 areas of installation: direction, location, mechanism (seatbelt or lower anchors), harness position, and tether use. Administered prior to, and immediately following, the intervention. The five question 10-point Likert scale assessment is scored 1-10 (1 = not confident; 10 = very confident). Confidence is defined as a 9 or 10 on the Likert scale.
Measured: 30 minutes
15-Question Car Seat Installation Knowledge Test
Self reported objective knowledge test with questions about the four steps for child passenger safety (rear facing seat, forward facing seat, booster seat, and seat belt/shoulder harness) and the LATCH (Lower Anchors and Tethers for Children) system. The test contains true/false, multiple-choice, and fill in the blank questions. Each question is worth 1 point for a total of 15 points. Adequate car seat knowledge is defined as 10 or more questions correct.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startAug 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Passenger SafetyStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Kuroiwa, MHI, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720289
- Sponsor's protocol ID
- 11-045
- Status last verified
- Mar 2016
- First submitted
- 16 Mar 2016
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Car Seat Education: What Works Best?
- ClinicalTrials.gov ID
- NCT02720289
- Acronym / sponsor ID
- 11-045
- Conditions
- Child Passenger Safety
- Keywords
- injury prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares a video-based social learning method to the traditional didactic method as a new way to teach caregivers about child passenger safety, including how to install a car seat. Half of the caregivers will attend the video-based social learning class, while the other half will attend the traditional didactic class. The investigators hypothesize that the video-based social learning method will lead to an equal or greater increase in caregiver child passenger safety proficiency when compared to the traditional didactic method.
Detailed description
Previous studies have demonstrated the effectiveness of child passenger safety education, however, there is limited research identifying an optimal teaching method.
Social learning teaching methods are beneficial in promoting health-behavior change. The social learning theory hypothesizes that people learn and change their behavior by observation and modeling. The video used in the social learning method shows parents as role models methodically teaching proper car seat installation in a vehicle.
Traditionally, child passenger safety education classes are didactic in design, relying on lecture formats and live demonstrations. The didactic method includes verbal instructions from a child passenger safety technician about car seat installation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-based social learning | Experimental | Other: Video-based social learning classVideo-based social learning class |
| Traditional didactic | Active comparator | Other: Traditional didactic classTraditional didactic class |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parents or caregivers of car seat-age children (age zero to three years)
- Participation in the Kids Ride Safe Program
Key exclusion criteria (1 listed)
- Spoke a language other than English or Spanish
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 |
|---|---|---|
| Video-based social learning classBrief child passenger safety lecture by a child passenger safety technician and viewing of a car seat video. | Other | Video-based social learning |
| Traditional didactic classChild passenger safety lecture by a child passenger safety technician. | Other | Traditional didactic |
Primary outcome
5-Item Car Seat Installation Demonstration Measure
Time frame: 30 minutes
Each participant will install a car seat in their vehicle prior to, and immediately following, the intervention. A child passenger safety technician observing the installation and blinded to the intervention, will use this measure to evaluate the 5 areas of installation: direction, location, mechanism (seatbelt or lower anchors), harness position, and tether use. Participants will only be evaluated on installation demonstration areas relevant to their vehicle and car seat. Each item is scored correct or incorrect. Correct car seat installation is defined as all applicable items marked correct.
2 secondary outcomes
5-Item Confidence in Car Seat Installation Ability Assessment
Time frame: 30 minutes
15-Question Car Seat Installation Knowledge Test
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
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.
Erin Kuroiwa, MHI principal investigator
Phoenix Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based social learning class and Traditional didactic class in people with Child Passenger Safety, run by Phoenix Children's Hospital 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 2 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 25 Mar 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
5-Item Car Seat Installation Demonstration Measure (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2016.