NCT03573830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
731

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 24, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

18 days

First QC Date

June 5, 2018

Results QC Date

September 2, 2020

Last Update Submit

November 20, 2020

Conditions

Keywords

Child Passenger InjuryChild Restraint SystemsTraffic Accidents

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    Immediately before intervention; immediately after intervention (the mean duration of the intervention was 3 minutes)

  • General Knowledge of Booster Seats

    immediately after intervention (the mean duration of the intervention was 3 minutes)

  • Projected Intent to Use

    Immediately after intervention (the mean duration of the intervention was 3 minutes)

  • Interest in the Communication Material

    Immediately after intervention (the mean duration of the intervention was 3 minutes)

  • Interest in Additional Information

    Immediately after intervention (the mean duration of the intervention was 3 minutes)

  • +2 more secondary outcomes

Study Arms (2)

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

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.

Behavioral: Enhanced material

Interventions

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).

Also known as: Current Transport Canada material
Current 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).

Also known as: Enhanced Transport Canada material
Enhanced material

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- Child has a physical condition that requires special transportation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Children's Hospital Research Institute

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (4)

  • 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.

    PMID: 21819828BACKGROUND
  • Committee 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.

    PMID: 21422088BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

First: It is difficult to determine if findings are behaviorally meaningful, because the instruments used are new. Second: The presence of ceiling effects indicate that the effect was underestimated.

Results Point of Contact

Title
Dr. Mariana Brussoni
Organization
BC Children's Hospital Research Institute

Study Officials

  • Mariana Brussoni, PhD

    University of British Columbia, BC Children's Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 5, 2018

First Posted

June 29, 2018

Study Start

December 10, 2018

Primary Completion

December 28, 2018

Study Completion

December 28, 2018

Last Updated

November 24, 2020

Results First Posted

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

The data set and supporting documents will be available from Dr. Brussoni upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
until 2025
Access Criteria
Amy scholarly requests will be considered.

Locations