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Randomized Control Trial of Booster Seat Education Material to Increase Perceived Benefit Among Parents

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: NCT03573830
Recruitment Status : Completed
First Posted : June 29, 2018
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Child and Family Research Institute
Information provided by (Responsible Party):
Mariana Brussoni, University of British Columbia

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Wounds and Injuries Behavioral: Transport Canada material Behavioral: Enhanced material Not Applicable

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:

  1. Participants will complete a baseline questionnaire.
  2. 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.
  3. 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.
  4. Participants will complete post-intervention questionnaire.
  5. 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.
  6. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 745 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

PARTICIPANT MASKING: Participants will be told the purpose of the study is to evaluate parents' reactions to two different information materials about booster seats and seatbelts.

INVESTIGATOR MASKING: The study will be conducted entirely online using a online research platform, so allocation will be masked to all investigators.

OUTCOMES ASSESSOR MASKING: Outcome evaluation will be conducted online using an online survey tool, so allocation will be masked to outcome assessors.

STATISTICAL ANALYSIS: Allocation in the online survey will be coded using random numbers unknown to the person conducting statistical analysis.

Primary Purpose: Prevention
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.
Actual Study Start Date : December 10, 2018
Actual Primary Completion Date : December 28, 2018
Actual Study Completion Date : December 28, 2018

Arm Intervention/treatment
Active Comparator: Current material
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
Behavioral: 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).
Other Name: Current Transport Canada material

Experimental: Enhanced material
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.
Behavioral: Enhanced 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).
Other Name: Enhanced Transport Canada material




Primary Outcome Measures :
  1. Change in perceived safety benefit of booster seats as assessed by the Booster Seat Attitudes Scale (BSAS) (Cunningham et al., 2011) [ Time Frame: Immediately before intervention; immediately after intervention ]
    The BSAS is a standardized questionnaire that measures parents attitudes towards and knowledge of booster seats. The BSAS has been validated and tested in a Canadian sample of parents. The Benefit subscale reported good internal consistency: Cronbach's alpha=0.85. (Cunningham et al., 2011)


Secondary Outcome Measures :
  1. Change in intention to use booster seats as assessed by the BSAS (Cunningham et al., 2011) [ Time Frame: Immediately before intervention; immediately after intervention ]
    The BSAS is a standardized questionnaire that measures parents' attitudes towards and knowledge of to booster seats. The BSAS has been validated and tested in a Canadian sample of parents. The Intent subscale of the BSAS reported good internal consistency: Cronbach's alpha=0.84. (Cunningham et al., 2011)

  2. Recall of booster seat information [ Time Frame: Immediately after intervention ]
    Participants will be asked questions to assess how much information they were able to retain: how booster seats prevent injuries as well as guidelines and recommendations.

  3. Change in subjective estimate of the impact of the intervention on other parents [ Time Frame: Immediately before intervention; immediately after intervention ]
    7-point Likert scale

  4. Interest in the communication material [ Time Frame: Immediately after intervention ]
    Number of seconds spent reviewing the material

  5. Interest in additional information [ Time Frame: Immediately after intervention ]
    Whether parents review additional information offered as external links to legislation, car seat clinics, and list of product recalls. Measured as "Yes" or "No".



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.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Child has a physical condition that requires special transportation


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): NCT03573830


Locations
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Canada, British Columbia
British Columbia Children's Hospital Research Institute
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Child and Family Research Institute
Investigators
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Principal Investigator: Mariana Brussoni, PhD University of British Columbia, BC Children's Hospital Research Institute

Publications:
Ishikawa 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

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Responsible Party: Mariana Brussoni, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03573830    
Other Study ID Numbers: H14-01569
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data set will be available from Dr. Brussoni upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mariana Brussoni, University of British Columbia:
Child Passenger Injury
Child Restraint Systems
Traffic Accidents
Additional relevant MeSH terms:
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Wounds and Injuries