Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000399796
Ethics application status
Approved
Date submitted
17/02/2022
Date registered
8/03/2022
Date last updated
29/04/2022
Date data sharing statement initially provided
8/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Educational and Developmental Gains in Early Childhood (EDGE) Study: Evaluating the impact of Universal 3-year-old Kindergarten in Victoria
Scientific title
Giving Young Children an ‘EDGE’: Educational and Developmental Gains in Early Childhood Evaluating the Impact of Universal 3-year-old Kindergarten in Victoria
Secondary ID [1] 306375 0
Ian Potter Foundation Grant Reference 31110966
Universal Trial Number (UTN)
Trial acronym
The EDGE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early childhood education and care 325297 0
Cognitive development 325298 0
Language development 325299 0
Social-emotional development 325300 0
Behavioural development 325301 0
Condition category
Condition code
Mental Health 322696 322696 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 322697 322697 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Victorian state government in Australia is introducing a staggered roll-out of universal provision of funded 3-year-old kindergarten in addition to the existing universal 4-year-old kindergarten program. The roll-out is being conducted across three years by local government area (LGA). Funded three-year-old kindergarten was introduced in six regional LGAs in 2020 (Arm 1), 15 regional LGAs in 2021 (Arm 2) and the remaining 58 regional and metropolitan LGAs in 2022 (Arm 3). The 3-year-old kindergarten program is being delivered in participating early childhood education and care (ECEC) services by qualified Early Childhood Teachers, requiring minimum Bachelors (3 years) qualification. The exposure is children who receive two years of universal funded kindergarten (3- and 4-year-old) during the state-wide roll-out.

The study will recruit children attending a 4-year-old kindergarten program from selected ECEC services in each Arm of the roll-out in 2022, 2023 and 2024. Children recruited in 2022 who are attending selected services in Arms 1 and 2 and those recruited in 2023-2024 from selected services in Arms 1, 2 and 3 are the exposure group. These children will have attended services that were delivering two years of funded kindergarten at the time they were eligible to commence 3-year-old kindergarten.

In a kindergarten program, children use play to build their language skills and learn about numbers and patterns. They also learn how to get along with others, share, listen, and manage their emotions. Teachers and educators help children become curious, creative and confident about learning.

Children’s cognitive, language, social-emotional and behavioural development will be measured as the primary outcomes. Primary outcomes will be examined once at the end of each child's 4-year-old kindergarten year (occurring 2022-24) via standardised direct child assessment (approximately 1 hour) and parent and teacher questionniare; and again in children's Year 3 of primary school for all children enrolled in a Victorian primary school, via linked Victorian Curriculum and Assessment Authority standardised assessment data (occurring 2026-28).
Intervention code [1] 322807 0
Not applicable
Comparator / control treatment
The comparator is children who received one year of universal funded kindergarten (4-year-old) during the state-wide roll-out and have not received a year of universal funded 3-year-old kindergarten.

Children recruited in 2022 who are attending 4-year-old kindergarten services in Arm 3 are the comparator group. These children will have attended services that were not yet delivering a funded 3-year-old kindergarten program in the year prior. These services were conducting business as usual and delivering the early childhood education and care services that they provided prior to the roll-out of funded 3-year-old kindergarten. This group will serve as a between-arm comparator (no funded 3-year-old kindergarten), to compare with children recruited from services in Arms 1 and 2 in 2022-2024 (delivering funded 3-year-old kindergarten) and as a within-arm comparator, to compare children recruited in Arm 3 in 2022 (no funded 3-year-old kindergarten) with children recruited in Arm 3 in 2023-24 (delivering funded 3-year-old kindergarten).
Control group
Active

Outcomes
Primary outcome [1] 330497 0
Applied Problems subtest of the Woodcock Johnson IV (WJIV) Tests of Achievement (Schrank, F. A., McGrew, K. S., & Mather, N., 2014) as a measure of cognitive development. Age-adjusted standard scores
Timepoint [1] 330497 0
At the end of children’s 4-year-old kindergarten year, during Term 4 (Oct-Dec).
Primary outcome [2] 330498 0
Letter-Word Identification subtest of the Woodcock Johnson IV (WJIV) Tests of Achievement (Schrank, F. A., McGrew, K. S., & Mather, N., 2014) as a measure of language development. Age-adjusted standard scores.
Timepoint [2] 330498 0
At the end of children’s 4-year-old kindergarten year, during Term 4 (Oct-Dec).
Primary outcome [3] 330499 0
Picture Vocabulary subtest of the Woodcock Johnson IV (WJIV) Tests of Oral Language (Schrank, F. A., McGrew, K. S., & Mather, N., 2014) as a measure of language development. Age-adjusted standard scores
Timepoint [3] 330499 0
At the end of children’s 4-year-old kindergarten year, during Term 4 (Oct-Dec).
Secondary outcome [1] 406432 0
Understanding Directions subtest of the Woodcock Johnson IV (WJIV) Tests of Oral Language (Schrank, F. A., McGrew, K. S., & Mather, N., 2014) as a measure of language development. Age-adjusted standard scores. Primary outcome.
Timepoint [1] 406432 0
At the end of children’s 4-year-old kindergarten year, during Term 4 (Oct-Dec).
Secondary outcome [2] 406433 0
Devereux Early Childhood Assessment Preschool Program, 2nd Edition (LeBuffe, P. A., Naglieri, J. A., 2012) total score on both parent and teacher reported scales. The Devereux Early Childhood Assessment examines within-child protective factors central to social and emotional health and resilience and will be used to measure social-emotional development. Primary Outcome.
Timepoint [2] 406433 0
At the end of children’s 4-year-old kindergarten year, during Term 4 (Oct-Dec).
Secondary outcome [3] 406434 0
The Strengths and Difficulties Questionnaire (SDQ) (Goodman, R., 1997) total score on parent reported scales. The SDQ is a brief behavioural screening questionnaire, which will be used to measure social-emotional and behavioural development. Primary Outcome
Timepoint [3] 406434 0
At the end of children’s 4-year-old kindergarten year, during Term 4 (Oct-Dec).
Secondary outcome [4] 406435 0
Childhood Executive Functioning Inventory (CHEXI) (Thorell, L. B., & Nyberg, L., 2008) total score on both parent and teacher reported scales. The CHEXI will be used as a measure of cognitive development. Primary Outcome.
Timepoint [4] 406435 0
At the end of children’s 4-year-old kindergarten year, during Term 4 (Oct-Dec).
Secondary outcome [5] 407121 0
School Entry Health Questionnaire (SEHQ) parent report of child health and wellbeing as they begin primary school in Victoria.
Timepoint [5] 407121 0
Linked data collected when children commence their first year of primary school.
Secondary outcome [6] 407122 0
English Online assessment tool for the English skills (reading, writing and speaking and listening) of students as they begin primary school in Victoria.
Timepoint [6] 407122 0
Linked data collected when children commence their first year of primary school.
Secondary outcome [7] 407123 0
The National Assessment Program – Literacy and Numeracy (NAPLAN) scores for tests of reading, writing, spelling, grammar and punctuation, and numeracy.
Timepoint [7] 407123 0
Linked data collected when children are in Year 3 of primary school.

Eligibility
Key inclusion criteria
Parents or legal guardians and their children, who are attending a 4-year old kindergarten program at participating early childhood education and care services at the time of study recruitment.

Early Childhood Teachers currently teaching a 3- and/or 4-year-old kindergarten program at participating early childhood education and care services.

Directors of participating early childhood education and care services.
Minimum age
3 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children who completed a previous year of 4-year-old kindergarten, e.g. children who repeated a year of kindergarten prior to commencing primary school.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
A cluster randomised sampling design will be used to select the ECEC services in this study. The intention is to recruit a sample of ECEC services that are representative of the services in each year (Arm) of the Victorian 3-year-old kindergarten roll-out and matched across Arms on population characteristics.
A target sample size of 95 ECEC services and 1350 children per year of the study has been set using a precision-based approach to sample size calculation. The sample size is based on detecting a small to medium effect size (f2 of 0.05) on the Woodcock-Johnson IV developmental assessments and The Devereux Early Childhood Assessment Preschool Program at 4 years with 80% power and a 5% level of statistical significance. Sample size has been adjusted for an intra-cluster correlation effect at the service level of 0.3, and that each cluster will include on average 15 children per service (approximately 70% of the average 4-year-old kindergarten group).

The sample of 95 services will be drawn from the three years of initial implementation of 3-year-old kindergarten, with a breakdown of 15 services from Arm 1 (2020 roll-out), 30 services from Arm 2 (2021) and 50 services from Arm 3 (2022). As the primary comparison of interest is between study Arm 3 and the combination of study Arms 1 and 2, and as Arm 1 has fewer eligible services than Arm 2, the above breakdown of services per arm was established.

Each arm will be proportionately stratified using a sampling frame that incorporates Socio-Economic Indexes for Areas (SEIFA) quintile (5 strata) and current National Quality Standards (NQS) rating (3 strata) to ensure the target sample is differentiated by service quality and the socio-economic status of the families within. The Victorian Department of Education and Training implemented 3-year-old kindergarten in 2020 and 2021 (Arms 1 and 2) in communities with relatively lower SEIFA codes. Arm 3 is partially matched to Arms 1 and 2 based in SEIFA and NQS, and partially representative, with adjustments made to ensure services in the two highest SEIFA quintiles are not under-represented.

To determine how two years of kindergarten predicts 4-year-old developmental outcomes, multivariable linear regression models will be used with years of kindergarten as the predictor (categorical; two years compared to one) and cognitive, language, social-emotional and behavioural development as the primary outcomes (continuous). We will adjust for service characteristics, quality, child and family variables. Subgroup analysis will be conducted to examine the association between years of kindergarten and 4-year-old developmental outcomes for children experiencing disadvantage.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/03/2022
Actual
7/04/2022
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
4050
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310728 0
Charities/Societies/Foundations
Name [1] 310728 0
Paul Ramsay Foundation
Country [1] 310728 0
Australia
Funding source category [2] 310807 0
Charities/Societies/Foundations
Name [2] 310807 0
Ian Potter Foundation
Country [2] 310807 0
Australia
Primary sponsor type
University
Name
Melbourne Graduate School of Education, The University of Melbourne
Address
REEaCH Hub, Ground Floor Kwong Lee Dow Building
234 Queensberry St
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 311952 0
Charities/Societies/Foundations
Name [1] 311952 0
The Front Project
Address [1] 311952 0
Level 18, 1 Nicholson Street,
East Melbourne VIC 3002
Country [1] 311952 0
Australia
Other collaborator category [1] 282169 0
University
Name [1] 282169 0
The Melbourne Institute of Applied Economic and Social Research, The University of Melbourne
Address [1] 282169 0
Level 5, Faculty of Business and Economics Building
111 Barry Street
Melbourne VIC 3010
Country [1] 282169 0
Australia
Other collaborator category [2] 282170 0
Government body
Name [2] 282170 0
Department of Education and Training Victoria
Address [2] 282170 0
2 Treasury Place
East Melbourne
Victoria, 3002
Country [2] 282170 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310304 0
The University of Melbourne Human Ethics Committee
Ethics committee address [1] 310304 0
Ethics committee country [1] 310304 0
Australia
Date submitted for ethics approval [1] 310304 0
24/06/2021
Approval date [1] 310304 0
21/09/2021
Ethics approval number [1] 310304 0
2021-21949-21211-3

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117190 0
Prof Patricia Eadie
Address 117190 0
Melbourne Graduate School of Education, The University of Melbourne
REEaCH Hub, Ground Floor Kwong Lee Dow Building
234 Queensberry St
Carlton VIC 3053
Country 117190 0
Australia
Phone 117190 0
+61 3 9035 4503
Fax 117190 0
Email 117190 0
[email protected]
Contact person for public queries
Name 117191 0
Patricia Eadie
Address 117191 0
Melbourne Graduate School of Education, The University of Melbourne
REEaCH Hub, Ground Floor Kwong Lee Dow Building
234 Queensberry St
Carlton VIC 3053
Country 117191 0
Australia
Phone 117191 0
+61 3 9035 4503
Fax 117191 0
Email 117191 0
[email protected]
Contact person for scientific queries
Name 117192 0
Patricia Eadie
Address 117192 0
Melbourne Graduate School of Education, The University of Melbourne
REEaCH Hub, Ground Floor Kwong Lee Dow Building
234 Queensberry St
Carlton VIC 3053
Country 117192 0
Australia
Phone 117192 0
+61 3 9035 4503
Fax 117192 0
Email 117192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Subsets of de-identified individual participant data, specific to an ethically approved and methodologically sound research proposal, will be shared.
When will data be available (start and end dates)?
Beginning 3 months and ending 10 years following main results publication.
Available to whom?
Researchers who provide a methodologically sound and ethically approved research proposal.
Available for what types of analyses?
Any analyses as stated on an ethically approved research proposal.
How or where can data be obtained?
Direct contact with the Principal Investigator:

Prof Patricia Eadie
Melbourne Graduate School of Education, The University of Melbourne
REEaCH Hub, Ground Floor Kwong Lee Dow Building
234 Queensberry St
Carlton VIC 3053
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.