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Trial registered on ANZCTR


Registration number
ACTRN12617001252303p
Ethics application status
Submitted, not yet approved
Date submitted
11/08/2017
Date registered
28/08/2017
Date last updated
14/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring the effectiveness of product information on the correct installation and use of child car seats
Scientific title
Measuring the effectiveness of product information on the correct installation and use of child car seats: a randomised controlled trial with parents of young children
Secondary ID [1] 292543 0
NHMRC grant AP1124981.
Secondary ID [2] 292658 0
The UNSW project number is RG160532 C\u0001\u001F
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Injury due to motor vehicle crashes 304198 0
Condition category
Condition code
Injuries and Accidents 303534 303534 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention targets incorrect restraint use through information supplied with the restraint, (as a supplement to the Australian Standards information on correct child restraint use). The content and format of the new product information will be supplied in an A3 instruction sheet; a video, accessible through smartphones via a QR code. The complete video is seven minutes long, and illustrates the six tasks to installing the restraint in the car and fitting the child into the restraint. The QR codes which relate to a specific tasks show just that segment of the video (varying in length from 30 seconds to 2 minutes), for example, "How to secure your child in the restraint". The intervention materials also includes laminated labels attached to the restraint, which will serve as a permanent reminder of the key aspects of correct installation and correct use. Together this intervention information (the A3 instruction sheet, QR coded videos demonstrating correct procedures, and the laminated 'reminder'swing tags) provides essential information needed to correctly use the restraint. The materials provide information on (i) how to correctly install the restraint in the vehicle, (ii) how to correctly adjust the restraint to fit their child, (iii) how to correctly secure the child in the restraint, and (iv) how to maintain correct use over time. No verbal instruction provided. All materials are available with the restraint at the point of purchase.

The materials incorporate low-literacy design principles, including an iterative consumer-testing process shown to be effective.

The consumer tested and standard instructions, together with the participant information sheet, will be inserted by the researchers into the box containing the restraint. The instructional materials will be placed in an envelope which will fit into the slit on top of the box. As the stores enter the study, researchers will visit each store on a schedule in agreement with the store manager, and insert the materials into the boxes. This step, of inserting materials into boxes at each store, will continue until the required number of participants has opted into the study for each store.
Intervention code [1] 298739 0
Behaviour
Intervention code [2] 298740 0
Prevention
Comparator / control treatment
The control group will receive the standard product information supplied with restraints at the point-of-sale – the Australian Standards required product information. To ensure concealment of intervention/control at the point-of-sale, control participants will receive a generic child passenger safety postcard detailing legislative requirements for the use of child restraints, by age of child. There is no QR code (i.e. no access to a video) on the control group materials.
Control group
Active

Outcomes
Primary outcome [1] 302904 0
The primary outcome measure is errors in installation of the restraint as observed by a trained researcher during the home assessment. A dichotomous outcome will be employed: either Yes there is any error, or No there is no error.
Timepoint [1] 302904 0
Six months after purchase of the restraint and receipt of intervention or control materials
Secondary outcome [1] 337397 0
Secondary outcome measures, based on video monitoring, includes adjustment checks made by the parent when the child is placed into the restraint, The first trip during the monitoring period will be used for this assessment. A dichotomous outcome will be employed: either Yes there were adjustment checks, or No there were no checks,
Timepoint [1] 337397 0
This outcome will be measured by analysis of the video film that is collected following the placement in the participant's vehicle for 24 hours. The primary outcome (above) will be assessed on Day 1 (which is 6 months after the purchase of the car seat and receipt of the intervention materials). This secondary outcome will be assessed following collection of the camera on Day 2. Assessment will take place at the research office, but relates to the first 21 hours after the researcher places the camera in the vehicle on Day 1.
Secondary outcome [2] 337872 0
Another secondary outcome is a count of observed errors in installation recorded by the trained researcher. This outcome will be assessed in person - when the trained researcher goes to the participant's home and observes directly how the restraint has been installed in the vehicle (Day 1 of assessment schedule, 6 months.after purchase of the car seat)
Timepoint [2] 337872 0
This will be measured on Day 1 of the assessment, which occurs six months after purchase of the restraint and receipt of the intervention or control materials. The materials are inserted in the restraint box and so they will be received by the participant at the time of purchase of the restraint.

Eligibility
Key inclusion criteria
Individual participants will be an expectant parent, or parent/primary carer of at least one child 0-8 yrs, hold a driver’s licence, own at least one vehicle, reside in the greater Sydney metropolitan area and be purchasing one of the nominated child restraints.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are grandparents or other carers who may be purchasing a restraint but are not themselves the primary carer of a child aged 0-8 years, and therefore they are not likely to be daily users of the restraints. Participants will also be excluded if they have already purchased a new restraint during the recruitment period to prevent double enrolment and minimise contamination.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Researcher who screens potential participants during the opt-in telephone call will be blinded to the individal's group allocation. Concealment will thus be achieved because the researcher is at a central administration site, and not where the potential participant enters the study, and information about the study material will not be covered as part of the screening questions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be conducted with the retail stores reprsenting the blocks/clusters. The clusters (n=22) will be stratfied based on two variables: 1) Geographic location - two groups: Sydney-based stores and non-Sydney-based stores; 2) socio-economic status of the suburb in which the store is located - two groups: lower 5 decile Socio-Economic Indexes for Areas (SEIFA) ranking and upper 5 decile SEIFA ranking
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on previous research, it is estimate that a 15% increase in correct child restraint use across a population is associated with a 10% reduction in serious injury and death among children in crashes. Using conservative intra-cluster correlation (ICC = 0.034) to estimate the influence of clustering within sites derived from a previous study, the study will have 80% power to detect a 15% increase in correct use of restraints from 55% to 70% at the 95% confidence level. This requires 748 participants to be recruited (n=374 in each arm), with 34 participants at each of the 22 sites. Allowing for drop out of 10% between recruitment and follow-up, we will recruit 38 participants at each site, which will provide a total sample of 836. To the extent possible, the same number of participants will be recruited from each site (retail store). This will also provide power to detect a 15% difference in our secondary outcome between the two groups.

An intention-to-treat approach will be used for all analyses. For the primary outcome measure, the proportion of participants with correct use will be compared between control and intervention groups using Donner’s adjusted chi-square test. The secondary outcome measure of adjustment checks made by the parent will be analysed in the same way. The secondary measure of the number of installation errors will be compared using Poisson regression. All primary analyses will be unadjusted. An exploratory subgroup analysis will be conducted on primary and secondary outcome measures with subgroups defined by health literacy scores (high and low literacy) since people from non-English speaking backgrounds have significantly poorer health literacy.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297115 0
Government body
Name [1] 297115 0
National Health and Medical Research Council
Address [1] 297115 0
Research Committee Secretariat NHMRC GPO Box 1421 Canberra ACT 2601
Country [1] 297115 0
Australia
Primary sponsor type
Individual
Name
Dr. Julie Brown
Address
Neuroscience Research Australia, PO Box 1165, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 296128 0
None
Name [1] 296128 0
Address [1] 296128 0
Country [1] 296128 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298293 0
UNSW Human Research Ethics Commitee
Ethics committee address [1] 298293 0
UNSW, Sydney, NSW 2052
Ethics committee country [1] 298293 0
Australia
Date submitted for ethics approval [1] 298293 0
14/07/2017
Approval date [1] 298293 0
Ethics approval number [1] 298293 0

Summary
Brief summary
With longstanding and widespread high rates of errors in child restraint use, there is a need to identify effective methods to address this problem. The study's hypothesis is that product materials developed using a consumer-driven approach will reduce errors in restraint use among purchasers of new child restraint systems.

A cluster randomised controlled trial (cRCT) will be conducted. Retail stores (n=22) in the greater Sydney area will be randomised into intervention sites (n=11) and control sites (n=11), stratified by geographic and socio-economic indicators. Participants (n=836) will enter the study on purchase of a restraint. Outcome measures are errors in installation of the restraint as observed by a trained researcher during a six-month follow-up home assessment, and adjustment checks made by the parent when the child is placed into the restraint. Process evaluation measures will also be collected during the home visit.

The content and format of the additional product information being tested will be supplied in an instruction booklet; a video, accessible through smartphones; as well as laminated labels attached to the restraint, which will serve as a permanent reminder of key aspects of correct installation and correct use. The intervention provides supplementary information to assist users to correctly use the restraint, i.e. (i) how to correctly adjust the restraint to fit their child (ii) how to correctly install the restraint in the vehicle, (iii) how to correctly secure the child in the restraint, and (iv) how to maintain correct use over time. These will be supplied in addition to the Australian Standards required product information. The number of installation errors, as well as correct use and adjustment checks made by the parent will be compared between control and intervention groups. This cluster randomised controlled trial will determine the effectiveness of targeted, consumer-driven information on actual error rates in use of restraints.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76614 0
Dr Julie Brown
Address 76614 0
Neuroscience Research Australia, Barker Street, Randwick, NSW 2031
Country 76614 0
Australia
Phone 76614 0
+61 2 93991000
Fax 76614 0
Email 76614 0
j.brown@neura.edu.au
Contact person for public queries
Name 76615 0
Dr Jane Elkington
Address 76615 0
Neuroscience Research Australia, Barker Street, Randwick, NSW 2031
Country 76615 0
Australia
Phone 76615 0
+61 2 93991000
Fax 76615 0
Email 76615 0
j.elkington@neura.edu.au
Contact person for scientific queries
Name 76616 0
Dr Julie Brown
Address 76616 0
Neuroscience Research Australia, Barker Street, Randwick, NSW 2031
Country 76616 0
Australia
Phone 76616 0
+61 2 93991000
Fax 76616 0
Email 76616 0
j.brown@neura.edu.au

No information has been provided regarding IPD availability
Summary results
No Results