Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000612213
Ethics application status
Approved
Date submitted
15/07/2009
Date registered
22/07/2009
Date last updated
5/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Buckle up safely: pre-school based interventions for appropriate use of child restraints
Scientific title
Cluster randomized trial of community pre-schools or childcare centres to evaluate the impact of an educational program in comparison to usual programming on appropriate use and misuse of child restraints.
Secondary ID [1] 252395 0
Buckle Up Safely
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appropriate use of child restraints in children aged 3-5 years.
An appropriate restraint is a forward facing child restraint (6 months - 4 years) and a booster seat (4-7 years). 237257 0
Misuse of child restraints in children aged 3-5 years.
Misuse of restraints can also degrade the level of protection provided in a crash. Restraint misuse is when the restraint system is not used as intended and can occur in both child restraints and adult seatbelts with or without booster seats. Examples include incorrect alignment of the belt and incorrect attachment of the restraint to the vehicle. Restraint misuse substantially increases injury risk. 237258 0
Condition category
Condition code
Public Health 239577 239577 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those centres allocated to the intervention will receive a targeted education and distribution program, incorporating targeted parent education including individual checking and installation advice, pre-school based information with reinforcement through teacher in-service workshops on curriculum appropriate programs and additional educational resources provided to centres.
The educational component will be delivered under the badging of the Kids and Traffic program by early childhood educators and will include:
1. Enhanced Kids and Traffic workshop for staff on child restraints. This will be delivered on a single occasion at the beginning of the school year and will be run in the evening for 2 hours.
2. Parent afternoon tea, with hands-on demonstration of child restraints. Restraint checks by research assistants trained in restraint inspection and referral to Roads and Traffic Authority (RTA) -certified restraint fitters for bolt fitting when required. This will be run for 1 hour on several days to ensure that all parents have the opportunity to attend.
3. Ongoing reinforcement and support to centre
Pamphlets and posters
Individualized brochures
Ongoing reinforcement with information in newsletters and updated posters and materials throughout year
Low cost restraint will be made available to those in need and will be subsidized to 25% of the recommended retail price (approximately $50).
Intervention code [1] 236943 0
Behaviour
Comparator / control treatment
Standard Kids and Traffic program, rather than enhanced program. All child care centres in NSW are offered staff in-service workshops from Kids and Traffic on road safety. These will continue to be available to control centres through newsletters and website information from Kids and Traffic.
The workshops offered by Kids and Traffic are 2 hour evening workshops which are administered by trained educators from the Kids and Traffic Program. The schedule can be accessed on the Kids and Traffic website: http://www.kidsandtraffic.mq.edu.au/
The workshops routinely available do not include a workshop dedicated to child restraint use.
Control group
Active

Outcomes
Primary outcome [1] 238373 0
Observed use of a child restraint which is appropriate for the child's age.
This will be assessed by research assistants who will observe restraint use in the car when children arrive at the centre.
An example of an inappropriate child restraint would be a 3 year old in a booster seat (rather than forward facing child restraint with harness) or a 4 year old in an adult seatbelt without a booster seat.
Timepoint [1] 238373 0
At least 3 months after the intervention and before end of the calender year.
Primary outcome [2] 238374 0
Observed misuse of a child restraint.
Misuse will be assessed by research assistants who will observe restraint use in the car when children arrive at the centre.
An example of misuse is child in a forward facing child restraint who has both arms out of the harness.
Timepoint [2] 238374 0
At least 3 months after the intervention and before end of the calender year.
Secondary outcome [1] 244819 0
Nil
Timepoint [1] 244819 0
Nil
Secondary outcome [2] 265102 0
None
Timepoint [2] 265102 0
None

Eligibility
Key inclusion criteria
Centre criteria:
Community pre-school or childcare centre with at least 20 families enrolled with children aged 3-5 years.
Centres in local government areas (LGA) with Socioeconomic Indices for Areas in the lowest 30% of LGA's in Sydney.
individual participants at the centre:
Parents of children aged 3-5 years enrolled at the participating centres will be eligible to participate in the research study.
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
English not the instructional language at centre
Parking and layout of centre not suitable for safe observation of vehicles on arrival at centre
A current active program engaging families on child restraint use.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Preschools and childcare centres will be invited to participate in this cluster randomised trial. The director will be sent a letter, followed by a visit to the centre where information about the study design will be provided. They will be advised that if they particiipate they could be allocated to the intervention or control group. The director, as the authorised representative, will sign a record of informed consent for the centre to participate in the study.
Group assignment will be randomly assigned by a non-blinded research assistant using the next sequentially-numbered opaque envelope containing group assignment.

Parents of children aged 3-5 years enrolled at the centre will be invited to complete an anonymous self-report questionnaire in the initial assessment. In the final outcome assessment, parents of children aged 3-5 years enrolled at the centre will be invited to participate in an interview and inspection of child restraint use in their vehicle on arrival at the centre. Informed consent will be gained from each participating parent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was by center. We used restricted randomization to balance service types (preschool or long daycare) and to limit differences in the proportion of children using age-appropriate restraints at baseline (self reported) to within 5% and families with household income <AU$60,000 per annum, families who speak a language other than English at home and the number of children enrolled at the centers to within 10%, between the two arms of the study. Randomization was performed by a study investigator (JS) who was not involved in recruitment or contact with the centers and who was blind to center identity.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/08/2009
Actual
1/10/2009
Date of last participant enrolment
Anticipated
31/12/2010
Actual
15/12/2010
Date of last data collection
Anticipated
Actual
30/06/2011
Sample size
Target
28
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 1893 0
2141
Recruitment postcode(s) [2] 1894 0
2142
Recruitment postcode(s) [3] 1895 0
2144
Recruitment postcode(s) [4] 1896 0
2145
Recruitment postcode(s) [5] 1897 0
2147
Recruitment postcode(s) [6] 1898 0
2148
Recruitment postcode(s) [7] 1899 0
2150
Recruitment postcode(s) [8] 1900 0
2160
Recruitment postcode(s) [9] 1901 0
2161
Recruitment postcode(s) [10] 1902 0
2162
Recruitment postcode(s) [11] 1903 0
2163
Recruitment postcode(s) [12] 1904 0
2164
Recruitment postcode(s) [13] 1905 0
2165
Recruitment postcode(s) [14] 1906 0
2166
Recruitment postcode(s) [15] 1907 0
2168
Recruitment postcode(s) [16] 1908 0
2170
Recruitment postcode(s) [17] 1909 0
2171
Recruitment postcode(s) [18] 1910 0
2173
Recruitment postcode(s) [19] 1911 0
2176
Recruitment postcode(s) [20] 1912 0
2177
Recruitment postcode(s) [21] 1913 0
2190
Recruitment postcode(s) [22] 1914 0
2193
Recruitment postcode(s) [23] 1915 0
2194
Recruitment postcode(s) [24] 1916 0
2196
Recruitment postcode(s) [25] 1917 0
2197
Recruitment postcode(s) [26] 1918 0
2198
Recruitment postcode(s) [27] 1919 0
2200
Recruitment postcode(s) [28] 1920 0
2211
Recruitment postcode(s) [29] 1921 0
2214
Recruitment postcode(s) [30] 1922 0
2558
Recruitment postcode(s) [31] 1923 0
2559
Recruitment postcode(s) [32] 1924 0
2560
Recruitment postcode(s) [33] 1925 0
2564
Recruitment postcode(s) [34] 1926 0
2566
Recruitment postcode(s) [35] 1927 0
2567
Recruitment postcode(s) [36] 1928 0
2747
Recruitment postcode(s) [37] 1929 0
2749
Recruitment postcode(s) [38] 1930 0
2750
Recruitment postcode(s) [39] 1931 0
2753
Recruitment postcode(s) [40] 1932 0
2754
Recruitment postcode(s) [41] 1933 0
2756
Recruitment postcode(s) [42] 1934 0
2759
Recruitment postcode(s) [43] 1935 0
2760
Recruitment postcode(s) [44] 1936 0
2761
Recruitment postcode(s) [45] 1937 0
2765
Recruitment postcode(s) [46] 1938 0
2767
Recruitment postcode(s) [47] 1939 0
2770

Funding & Sponsors
Funding source category [1] 237335 0
Government body
Name [1] 237335 0
National Health and Medical Research Council
Country [1] 237335 0
Australia
Primary sponsor type
University
Name
George Institute for International Health, University of Sydney
Address
The George Institute for International Health
University of Sydney
Level 7, 341 George Street
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 236821 0
University
Name [1] 236821 0
Prince of Wales Medical Research Institute, University of New South Wales
Address [1] 236821 0
Prince of Wales Medical Research Institute
Barker Street
Randwick NSW 2031
Country [1] 236821 0
Australia
Other collaborator category [1] 763 0
University
Name [1] 763 0
Kids and Traffic, Macquarie University
Address [1] 763 0
Early Childhood Road Safety Education Program
Kids and Traffic
Dow Corning Building
Macquarie University NSW 2109
Country [1] 763 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239448 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 239448 0
Level 6,
Jane Foss Russell Building - GO2
The University of Sydney NSW 2006
Ethics committee country [1] 239448 0
Australia
Date submitted for ethics approval [1] 239448 0
Approval date [1] 239448 0
11/06/2009
Ethics approval number [1] 239448 0
06-2009/11748

Summary
Brief summary
The purpose of this study is to see if hands-on demonstration of child restraints, seat distribution and explanation of the right child restraint for a pre-school child can increase the use of appropriate child restraints in children aged 3-5 years. This program will be given to parents and guardians in their child’s pre-school. We will determine whether it works by comparing 14 pre-schools who get the program to 14 pre-schools who do not at the end of the school year. The number of children correctly using appropriate child restraints will be compared between the two arms of the study.
It is known that a large proportion of pre-school aged children are not in appropriate child restraints, and/or are not restrained correctly, increasing their risk of injury in road crashes. We will develop and evaluate an educational intervention to increase correct and appropriate child restraint use in 3-5 year olds. The study design is a cluster randomised controlled trial and this type of design is considered a gold standard for evaluating the effectiveness of an intervention. Each of 28 pre-schools involved in the study will be randomly allocated to either receive the intervention or to continue with usual road safety programming. This randomised trial will be one of a small number of similar studies conducted internationally and the findings of this study will contribute important evidence for policy makers and road safety educators.
Trial website
Trial related presentations / publications
1: Hunter K, Keay L, Simpson JM, Brown J, Bilston LE, Fegan M, Cosgrove L,
Stevenson M, Ivers RQ. Program fidelity measures associated with an effective
child restraint program: Buckle-Up Safely. Am J Public Health. 2015
Mar;105(3):584-90. doi: 10.2105/AJPH.2014.302308. Epub 2015 Jan 20. PubMed PMID:
25602901.


2: Hunter K, Keay L, Clapham K, Lyford M, Brown J, Bilston L, Simpson JM,
Stevenson M, Ivers RQ. Buckle up safely (shoalhaven): a process and impact
evaluation of a pragmatic, multifaceted preschool-based pilot program to increase
correct use of age-appropriate child restraints. Traffic Inj Prev.
2014;15(5):483-90. doi: 10.1080/15389588.2013.833328. PubMed PMID: 24678571.


3: Brown J, Keay L, Hunter K, Bilston LE, Simpson JM, Ivers R. Increase in best
practice child car restraint use for children aged 2-5 years in low socioeconomic
areas after introduction of mandatory child restraint laws. Aust N Z J Public
Health. 2013 Jun;37(3):272-7. doi: 10.1111/1753-6405.12070. PubMed PMID:
23731111.


4: Keay L, Hunter K, Brown J, Simpson JM, Bilston LE, Elliott M, Stevenson M,
Ivers RQ. Evaluation of an education, restraint distribution, and fitting program
to promote correct use of age-appropriate child restraints for children aged 3 to
5 years: a cluster randomized trial. Am J Public Health. 2012
Dec;102(12):e96-102. doi: 10.2105/AJPH.2012.301030. Epub 2012 Oct 18. PubMed
PMID: 23078492; PubMed Central PMCID: PMC3519299.


5: Keay L, Hunter K, Brown J, Bilston LE, Simpson JM, Stevenson M, Ivers RQ.
Child restraint use in low socio-economic areas of urban Sydney during transition
to new legislation. Accid Anal Prev. 2013 Jan;50:984-91. doi:
10.1016/j.aap.2012.08.002. Epub 2012 Aug 24. PubMed PMID: 22921907.


6: Ivers RQ, Keay L, Brown J, Bilston LE, Hunter K, Simpson JM, Stevenson M.
Buckle up safely: a cluster randomised trial to evaluate the effectiveness of a
pre-school based program to increase appropriate use of child restraints. BMC
Public Health. 2011 Jan 6;11:16. doi: 10.1186/1471-2458-11-16. PubMed PMID:
21211053; PubMed Central PMCID: PMC3024224.
Public notes

Contacts
Principal investigator
Name 29901 0
Prof Rebecca Ivers
Address 29901 0
Injury Division, George Institute for International Health, PO Box M201 Missenden Road NSW 2050
Country 29901 0
Australia
Phone 29901 0
61296570300
Fax 29901 0
Email 29901 0
[email protected]
Contact person for public queries
Name 13148 0
Dr Lisa Keay
Address 13148 0
Injury Division
George Institute for International Health
PO Box M201 Missenden Road
NSW 2050
Country 13148 0
Australia
Phone 13148 0
+61 2 9657 0335
Fax 13148 0
+61 2 9657 0301
Email 13148 0
[email protected]
Contact person for scientific queries
Name 4076 0
Prof Rebecca Ivers
Address 4076 0
Injury Division
George Institute for International Health
PO Box M201 Missenden Road
NSW 2050
Country 4076 0
Australia
Phone 4076 0
+61 2 9657 0361
Fax 4076 0
+61 2 9657 0301
Email 4076 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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