Wounds and InjuriesNCT03573830
Randomized Control Trial of Booster Seat Education Material to Increase Perceived Benefit Among Parents
A study testing Transport Canada material and Enhanced material in people with Wounds and Injuries, run by University of British Columbia at 1 site in Canada.
Trial summary
Seat belts protect people from injuries by diverting crash forces to stronger anatomical structures: the rib cage and the pelvis. Children between the ages of 4 and 8 years are typically not tall enough to wear the seat belt correctly across the chest and hips, and instead wear it on their abdomen and neck. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Transport Canada material and Enhanced material
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 731 participants
- Where
- 1 siteCanada
- Study dates
- 10 Dec 2018to 28 Dec 2018
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Parents of children 4 thorough 8 years old
- Residing in any Canadian Province
- Fluent in English
- Drive with their child at least once a month
Who cannot join
- Child has a physical condition that requires special transportation
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital Research Institute
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Randomized Control Trial of an Intervention to Increase Perceived Safety Benefit of Booster Seats Among Parents of Children 4 to 8 Years Old in Canada.
Seat belts protect people from injuries by diverting crash forces to stronger anatomical structures: the rib cage and the pelvis. Children between the ages of 4 and 8 years are typically not tall enough to wear the seat belt correctly across the chest and hips, and instead wear it on their abdomen and neck. When worn in this way, seat belts direct crash forces to these parts of the body, potentially causing serious damage to internal organs and the spine. For this reason, children of these ages need to use a booster seat; a safety device that prevents seat belt related injuries by raising the child and ensuring the straps are correctly worn across the thorax and hips. In Canada, half of the children who should be using booster seats are prematurely restrained using only the seat belt. The present research project seeks to develop and test a novel intervention to encourage booster seat use.
Many Canadian provinces have enacted laws mandating use, and have developed and implemented evidence-based education programs. Despite these efforts, new approaches to encourage booster seat use are required. In 2010, more than 10 years after booster seats became mandatory, the rate of utilization in the Canadian provinces of Ontario and Quebec was still low (25%). Furthermore, recent research indicates that parents' perception of the safety benefit of booster seats is the strongest predictor of use, yet no study to date has tested an education intervention that increases perceived benefit; instead, these interventions focus on teaching guidelines (i.e., minimum and maximum age, height, and weight to determine when a child should use a booster seat, and when it is safe for a child to use only the seat belt).
The present approach to encouraging booster seat use is novel, because it increases perceived benefit by teaching two principles: (1) seat belts prevent injuries by redirecting crash forces to stronger parts of the body (rib cage and pelvis); and (2), without booster seats, children would wear the seat belt on their abdomen and neck, which directs crash forces to more vulnerable anatomical structures (internal organs and spine). Once parents grasp these two principles, they are expected to better appreciate the safety benefit of booster seats and, thus, be more likely to use them.
Read the detailed description
The education material currently available in the Transport Canada website will be enhanced, by adding an introduction that describes how seat belts and booster seats work (i.e., these devices help redirect crash forces to stronger parts to the body: rib cage and pelvis).
Objective of the trial: To determine if the enhanced material is better than the current Transport Canada information at increasing perceived safety benefit and intention to use booster seats.
Design: Concurrent two-group parallel randomized controlled trial.
Randomization: Block randomization will be used to assign participants to either intervention or control groups. Participants and researchers will be blinded to allocation.
Participants. 303 mothers and 303 fathers of children 4 to 8 years old will be invited to participate, irrespective of whether they use booster seats always, occasionally, or never. A sample of 606 participants provides sufficient power to detect a mean difference in perceived benefit that separates those parents who consistently restrain their child in booster seats from those who do not. Sample size was estimated with the TwoSampleMean function for trials that test superiority of interventions (TrialSize package for R). Participants in the trial will receive $1/each for the completion of the survey. Based on information from studies with similar characteristics, the expected response rate is 40%.
Setting and Procedures. The trial will be conducted entirely online. Participants will be recruited through an online market research firm, Maru/Matchbox, which maintains a nationwide panel of 130,000 individuals whose distribution represents the Canadian population. Maru/Matchbox will send an email invitation to participate along with a link to the online survey. The landing page of the survey will provide description of the study for parents to read. The online survey will be set up in such a way that participants won't be able to start answering questions, unless they consent by clicking the "I agree" button. Participants, will be advised to print and keep a copy of the consent form either as PDF or as hard copy. After consenting to participate, the online trial will proceed as follows:
- Participants will complete a baseline questionnaire.
- The system will randomly assign the participant to either the intervention or the control group. Randomization will be stratified by sex, child age, and jurisdiction to ensure both groups are equal.
- Participants in the intervention group will be presented the enhanced booster seat material, while participants in the control group will be presented the current Transport Canada booster seat material. Material provided to both groups will be stripped of logos (Transport Canada logos and corporate identity), but will be properly cited.
- Participants will complete post-intervention questionnaire.
- Participants in the intervention group will be asked one or two questions to ensure they did not misunderstood the information in an unintended way. If a parent answers incorrectly, the system will clarify the information immediately after.
- Participants in the control group will be given the option to view the enhanced booster seat material, in order to give them the opportunity to benefit from the intervention.
- Conditions
- Wounds and Injuries
- Being tested
- Transport Canada material, Enhanced material
- Keywords
- Child Passenger Injury, Child Restraint Systems, Traffic Accidents
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transport Canada materialBehavioural
Also called Current Transport Canada material
The current Transport Canada booster seat education material focuses on imparting guidelines; that is, it describes, in plain language, the minimum and maximum ages, heights, and weights to determine when a child should use a booster seat, and when it is safe for a child to use only the seat belt. This material does not describe the principle of operation of seat belts (i.e., redirecting crash forces to the rib cage and pelvis), nor the principle of operation of booster seats (i.e., ensuring the seat belt is placed correctly across the chest and hips).
Enhanced materialBehavioural
Also called Enhanced Transport Canada material
Enhancements to the booster seat education material were developed based on the hypothesis that parents would better appreciate the additional injury risk reduction afforded by booster seats, if they understand that: (1) seat belts prevent injuries by redirecting crash forces to stronger parts of the body (i.e., rib cage and pelvis); and (2), without booster seats, children would wear the seat belt on their abdomen and neck, which directs crash forces to more vulnerable anatomical structures (i.e., internal organs and spine).
| Study group | Role | What they receive |
|---|---|---|
| Current material | Active comparator | Participants in this arm will be shown the online Transport Canada Material that is currently available at: https://www.tc.gc.ca/en/services/road/child-car-seat-safety/installing-using-child-car-seat-booster-seat-seat-belt/stage-3-booster-seats.html Receives: Behavioral: Transport Canada material |
| Enhanced material | Experimental | Participants in this arm will be shown an enhanced version of the online Transport Canada Material, which includes an introduction explaining how booster seats prevent injuries caused by seat belts. Receives: Behavioral: Enhanced material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Safety Benefit of Booster Seats
Assessed with the Perceived Benefit sub-scale of the BSASabb (an abridged version of the Booster Seat Attitudes Scale, Cunningham et al., 2011). The Perceived Benefit subscale evaluates parents' perception of the general safety afforded by booster seats (e.g., prevents children from being injured during normal driving). The Perceived Benefit sub-scale of the BSASabb ranges from 1 to 5, and higher scores mean better outcome.
Measured: Immediately before intervention; immediately after intervention (the mean duration of the intervention was 3 minutes)
Change in Key Benefit of Booster Seats
Change in key safety was measured as the difference between post- and pre-intervention scores assessed with the Key Benefit sub-scale of the BSASabb (an abridged version of the Booster Seat Attitudes Scale, Cunningham et al., 2011). The Key Benefit sub-scale evaluates parents' perception of the safety afforded by booster seats in relation to potentially fatal injuries to the spine and neck, a key feature of booster seats. The Key Benefit sub-scale of the BSASabb ranges from 1 to 5 and higher scores mean better outcome.
Measured: Immediately before intervention; immediately after intervention (the mean duration of the intervention was 3 minutes)
Secondary outcomes (7)
Change in Intention to Use Booster Seats
Change in intention to use booster seats was measured as the difference between post- and pre-intervention scores in the Intent to Use sub-scale of the BSASabb (an abridged version of the Booster Seat Attitudes Scale, Cunningham et al., 2011). Intent to Use sub-scale evaluates parents' willingness to purchase and ensuring their child always rides on a booster seat. The Intention to Use of the BSASabb ranges from 1 to 5 and higher scores mean better outcome.
Measured: Immediately before intervention; immediately after intervention (the mean duration of the intervention was 3 minutes)
General Knowledge of Booster Seats
Participants were asked questions to assess how much general information about booster seats they retained: how booster seats prevent injuries as well as guidelines and recommendations. Scores ranges from 0 to 2 and higher scores mean better outcome.
Measured: immediately after intervention (the mean duration of the intervention was 3 minutes)
Projected Intent to Use
Participants were asked to estimate how likely were their peers to use about booster seats, after reviewing the information they were assigned. The questionnaire was based on the Booster Seat Attitudes Scale (Cunningham et al., 2011). The idea behind this measure is that people judgments about what others would do reflect, in part, what they would do (Loewenstein, 2005). The scale ranges from 1 to 5 and higher scores mean better outcome.
Measured: Immediately after intervention (the mean duration of the intervention was 3 minutes)
Interest in the Communication Material
Number of seconds spent reviewing the material.
Measured: Immediately after intervention (the mean duration of the intervention was 3 minutes)
Interest in Additional Information
Whether parents review additional information offered as external links to legislation, car seat clinics, and list of product recalls. Measured as "Yes" or "No".
Measured: Immediately after intervention (the mean duration of the intervention was 3 minutes)
Applied Knowledge of Booster Seats
Participants were shown a picture of a child incorrectly restrained and were asked to identify the mistakes in the picture. Scores ranges from 0 to 3 and higher scores mean better outcome.
Measured: Immediately after intervention (the mean duration of the intervention was 3 minutes)
Projected Intent to Learn
Participants were asked to estimate how likely were their peers to learn about booster seats, after reviewing the information they were assigned. The questionnaire was based on the Booster Seat Attitudes Scale (Cunningham et al., 2011). The idea behind this measure is that people judgments about what others would do reflect, in part, what they would do (Loewenstein, 2005). The scale ranges from 1 to 5 and higher scores mean better outcome.
Measured: Immediately after intervention (the mean duration of the intervention was 3 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start10 Dec 2018
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
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 (4)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Child and Family Research Institute
- Responsible party
- Principal investigator, Mariana Brussoni, University of British Columbia
- Investigators
- Mariana Brussoni, PhD, Principal investigator, University of British Columbia, BC Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573830
- Sponsor's protocol ID
- H14-01569
- Status last verified
- Nov 2020
- First submitted
- 5 Jun 2018
- Last updated
- 24 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data set and supporting documents will be available from Dr. Brussoni upon reasonable request.
Publications
Cunningham CE, Bruce BS, Snowdon AW, Chen Y, Kolga C, Piotrowski C, Warda L, Correale H, Clark E, Barwick M. Modeling improvements in booster seat use: a discrete choice conjoint experiment. Accid Anal Prev. 2011 Nov;43(6):1999-2009. doi: 10.1016/j.aap.2011.05.018. Epub 2011 Jun 25.
PubMed 21819828Committee on Injury, Violence, and Poison Prevention; Durbin DR. Child passenger safety. Pediatrics. 2011 Apr;127(4):788-93. doi: 10.1542/peds.2011-0213. Epub 2011 Mar 21.
PubMed 21422088Ishikawa T, Jiang A, Brussoni M, Reyna V, Weldon B, Bruce B, Pike I. Perceptions of injury risk associated with booster seats and seatbelts: the ejection stereotype hypothesis. Hypothesis Journal 15(1): e1.
A. W. Snowdon, A. Hussein, E. Ahmed, "Canadian National Survey on Child Restraint Use 2010" (AUTO21, 2011). https://www.tc.gc.ca/eng/motorvehiclesafety/resources-researchstats-child-restraint-survey-2010-1207.htm
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of an Intervention to Increase Perceived Safety Benefit of Booster Seats Among Parents of Children 4 to 8 Years Old in Canada.
- ClinicalTrials.gov ID
- NCT03573830
- Acronym / sponsor ID
- H14-01569
- Conditions
- Wounds and Injuries
- Keywords
- Child Passenger Injury, Child Restraint Systems, Traffic Accidents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Child and Family Research Institute
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Posted 24 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Seat belts protect people from injuries by diverting crash forces to stronger anatomical structures: the rib cage and the pelvis. Children between the ages of 4 and 8 years are typically not tall enough to wear the seat belt correctly across the chest and hips, and instead wear it on their abdomen and neck. When worn in this way, seat belts direct crash forces to these parts of the body, potentially causing serious damage to internal organs and the spine. For this reason, children of these ages need to use a booster seat; a safety device that prevents seat belt related injuries by raising the child and ensuring the straps are correctly worn across the thorax and hips. In Canada, half of the children who should be using booster seats are prematurely restrained using only the seat belt. The present research project seeks to develop and test a novel intervention to encourage booster seat use.
Many Canadian provinces have enacted laws mandating use, and have developed and implemented evidence-based education programs. Despite these efforts, new approaches to encourage booster seat use are required. In 2010, more than 10 years after booster seats became mandatory, the rate of utilization in the Canadian provinces of Ontario and Quebec was still low (25%). Furthermore, recent research indicates that parents' perception of the safety benefit of booster seats is the strongest predictor of use, yet no study to date has tested an education intervention that increases perceived benefit; instead, these interventions focus on teaching guidelines (i.e., minimum and maximum age, height, and weight to determine when a child should use a booster seat, and when it is safe for a child to use only the seat belt).
The present approach to encouraging booster seat use is novel, because it increases perceived benefit by teaching two principles: (1) seat belts prevent injuries by redirecting crash forces to stronger parts of the body (rib cage and pelvis); and (2), without booster seats, children would wear the seat belt on their abdomen and neck, which directs crash forces to more vulnerable anatomical structures (internal organs and spine). Once parents grasp these two principles, they are expected to better appreciate the safety benefit of booster seats and, thus, be more likely to use them.
Detailed description
The education material currently available in the Transport Canada website will be enhanced, by adding an introduction that describes how seat belts and booster seats work (i.e., these devices help redirect crash forces to stronger parts to the body: rib cage and pelvis).
Objective of the trial: To determine if the enhanced material is better than the current Transport Canada information at increasing perceived safety benefit and intention to use booster seats.
Design: Concurrent two-group parallel randomized controlled trial.
Randomization: Block randomization will be used to assign participants to either intervention or control groups. Participants and researchers will be blinded to allocation.
Participants. 303 mothers and 303 fathers of children 4 to 8 years old will be invited to participate, irrespective of whether they use booster seats always, occasionally, or never. A sample of 606 participants provides sufficient power to detect a mean difference in perceived benefit that separates those parents who consistently restrain their child in booster seats from those who do not. Sample size was estimated with the TwoSampleMean function for trials that test superiority of interventions (TrialSize package for R). Participants in the trial will receive $1/each for the completion of the survey. Based on information from studies with similar characteristics, the expected response rate is 40%.
Setting and Procedures. The trial will be conducted entirely online. Participants will be recruited through an online market research firm, Maru/Matchbox, which maintains a nationwide panel of 130,000 individuals whose distribution represents the Canadian population. Maru/Matchbox will send an email invitation to participate along with a link to the online survey. The landing page of the survey will provide description of the study for parents to read. The online survey will be set up in such a way that participants won't be able to start answering questions, unless they consent by clicking the "I agree" button. Participants, will be advised to print and keep a copy of the consent form either as PDF or as hard copy. After consenting to participate, the online trial will proceed as follows:
- Participants will complete a baseline questionnaire.
- The system will randomly assign the participant to either the intervention or the control group. Randomization will be stratified by sex, child age, and jurisdiction to ensure both groups are equal.
- Participants in the intervention group will be presented the enhanced booster seat material, while participants in the control group will be presented the current Transport Canada booster seat material. Material provided to both groups will be stripped of logos (Transport Canada logos and corporate identity), but will be properly cited.
- Participants will complete post-intervention questionnaire.
- Participants in the intervention group will be asked one or two questions to ensure they did not misunderstood the information in an unintended way. If a parent answers incorrectly, the system will clarify the information immediately after.
- Participants in the control group will be given the option to view the enhanced booster seat material, in order to give them the opportunity to benefit from the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current material | Active comparator | Behavioral: Transport Canada materialParticipants in this arm will be shown the online Transport Canada Material that is currently available at: https://www.tc.gc.ca/en/services/road/child-car-seat-safety/installing-using-child-car-seat-booster-seat-seat-belt/stage-3-booster-seats.html |
| Enhanced material | Experimental | Behavioral: Enhanced materialParticipants in this arm will be shown an enhanced version of the online Transport Canada Material, which includes an introduction explaining how booster seats prevent injuries caused by seat belts. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Parents of children 4 thorough 8 years old
- Residing in any Canadian Province
- Fluent in English
- Drive with their child at least once a month
Key exclusion criteria (1 listed)
- Child has a physical condition that requires special transportation
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 |
|---|---|---|
| Transport Canada materialAlso: Current Transport Canada materialThe current Transport Canada booster seat education material focuses on imparting guidelines; that is, it describes, in plain language, the minimum and maximum ages, heights, and weights to determine when a child should use a booster seat, and when it is safe for a child to use only the seat belt. This material does not describe the principle of operation of seat belts (i.e., redirecting crash forces to the rib cage and pelvis), nor the principle of operation of booster seats (i.e., ensuring the seat belt is placed correctly across the chest and hips). | Behavioural | Current material |
| Enhanced materialAlso: Enhanced Transport Canada materialEnhancements to the booster seat education material were developed based on the hypothesis that parents would better appreciate the additional injury risk reduction afforded by booster seats, if they understand that: (1) seat belts prevent injuries by redirecting crash forces to stronger parts of the body (i.e., rib cage and pelvis); and (2), without booster seats, children would wear the seat belt on their abdomen and neck, which directs crash forces to more vulnerable anatomical structures (i.e., internal organs and spine). | Behavioural | Enhanced material |
Primary outcome
Change in Perceived Safety Benefit of Booster Seats
Time frame: Immediately before intervention; immediately after intervention (the mean duration of the intervention was 3 minutes)
Assessed with the Perceived Benefit sub-scale of the BSASabb (an abridged version of the Booster Seat Attitudes Scale, Cunningham et al., 2011). The Perceived Benefit subscale evaluates parents' perception of the general safety afforded by booster seats (e.g., prevents children from being injured during normal driving). The Perceived Benefit sub-scale of the BSASabb ranges from 1 to 5, and higher scores mean better outcome.
Change in Key Benefit of Booster Seats
Time frame: Immediately before intervention; immediately after intervention (the mean duration of the intervention was 3 minutes)
Change in key safety was measured as the difference between post- and pre-intervention scores assessed with the Key Benefit sub-scale of the BSASabb (an abridged version of the Booster Seat Attitudes Scale, Cunningham et al., 2011). The Key Benefit sub-scale evaluates parents' perception of the safety afforded by booster seats in relation to potentially fatal injuries to the spine and neck, a key feature of booster seats. The Key Benefit sub-scale of the BSASabb ranges from 1 to 5 and higher scores mean better outcome.
7 secondary outcomes
Change in Intention to Use Booster Seats
Time frame: Immediately before intervention; immediately after intervention (the mean duration of the intervention was 3 minutes)
General Knowledge of Booster Seats
Time frame: immediately after intervention (the mean duration of the intervention was 3 minutes)
Projected Intent to Use
Time frame: Immediately after intervention (the mean duration of the intervention was 3 minutes)
Interest in the Communication Material
Time frame: Immediately after intervention (the mean duration of the intervention was 3 minutes)
Interest in Additional Information
Time frame: Immediately after intervention (the mean duration of the intervention was 3 minutes)
Applied Knowledge of Booster Seats
Time frame: Immediately after intervention (the mean duration of the intervention was 3 minutes)
Projected Intent to Learn
Time frame: Immediately after intervention (the mean duration of the intervention was 3 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21819828Cunningham CE, Bruce BS, Snowdon AW, Chen Y, Kolga C, Piotrowski C, Warda L, Correale H, Clark E, Barwick M. Modeling improvements in booster seat use: a discrete choice conjoint experiment. Accid Anal Prev. 2011 Nov;43(6):1999-2009. doi: 10.1016/j.aap.2011.05.018. Epub 2011 Jun 25.
- Background: PubMed 21422088Committee on Injury, Violence, and Poison Prevention; Durbin DR. Child passenger safety. Pediatrics. 2011 Apr;127(4):788-93. doi: 10.1542/peds.2011-0213. Epub 2011 Mar 21.
- BackgroundIshikawa T, Jiang A, Brussoni M, Reyna V, Weldon B, Bruce B, Pike I. Perceptions of injury risk associated with booster seats and seatbelts: the ejection stereotype hypothesis. Hypothesis Journal 15(1): e1.
- BackgroundA. W. Snowdon, A. Hussein, E. Ahmed, "Canadian National Survey on Child Restraint Use 2010" (AUTO21, 2011). https://www.tc.gc.ca/eng/motorvehiclesafety/resources-researchstats-child-restraint-survey-2010-1207.htm
- Transport Canada information on booster seatsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data set and supporting documents will be available from Dr. Brussoni upon reasonable request.
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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.
Mariana Brussoni, PhD principal investigator
University of British Columbia, BC Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transport Canada material and Enhanced material in people with Wounds and Injuries, run by University of British Columbia at 1 site in Canada.
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 4 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 24 Nov 2020. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 24 Nov 2020). 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?
Change in Perceived Safety Benefit of Booster Seats (time frame: Immediately before intervention; immediately after intervention (the mean duration of the intervention was 3 minutes)). 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 NCT03573830, which also lists 4 linked publications.
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 24 Nov 2020.