Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000214831p
Ethics application status
Submitted, not yet approved
Date submitted
30/09/2020
Date registered
3/03/2021
Date last updated
3/03/2021
Date data sharing statement initially provided
3/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Early Years Initiative Evaluation: the impact on children, families and communities of community-driven, evidence-informed actions to improve outcomes in children from birth to the start of full-time school in four diverse Western Australian communities.
Scientific title
Evaluation of the Early Years Initiative: impact on early childhood developmental outcomes in children aged 0-4 years in four Western Australian communities
Secondary ID [1] 302255 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EYI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
paediatric developmental delay 319061 0
paediatric social learning vulnerability 319062 0
low birthweight 319063 0
early childhood dental decay 319064 0
otitis media 319065 0
Condition category
Condition code
Public Health 317012 317012 0 0
Health promotion/education
Reproductive Health and Childbirth 317014 317014 0 0
Antenatal care
Oral and Gastrointestinal 317015 317015 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Ear 317016 317016 0 0
Normal ear development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Early Years Initiative (EYI) began in 2018 as a ten-year project and is underpinned by a view that communities, informed by relevant scientific evidence and with sufficient capacity-building, are best placed to design, implement, and evaluate solutions to meet their needs. The four partner communities involved in the EYI (one each of metropolitan, regional, remote, and very remote communities) will be supported by the State Government and the Minderoo Foundation to design, implement, review and adapt locally-driven activities that will be pursued to improve development, health, and learning outcomes for children and families within their community. For example, they may introduce a model of 'community connectors' to reduce isolation among 'difficult to reach' families and increase their engagement with existing services; or they may establish a weekly 'community cook-up' event to improve food security and healthy eating in low income households with young children. The duration of activities will run from the time each Community Plan is endorsed through to 2028.

The evaluation of impact of the EYI comprises six modules reflecting the objectives of the EYI articulated in the Initiative's program logic.

Module 1: Process Evaluation -> To identify which EYI activities were implemented in each community, for whom and over what duration, and where possible with what intensity, as measured by administrative and EYI process data (not being assessed as part of the current registration record).

Module 2: Outcomes Evaluation (this module is the focus of this project registration - i.e. the module that directly measures outcomes for children aged 0-4) --> To determine whether the EYI activities improve the development, health, and learning of children from conception to age four in each community, as measured by changes across three time points (2021 - 2024 - 2027) in linked administrative data collected by key State Government agencies (i.e.: Health, Education and Communities). These retrospective data items will be extracted and linked by the WA Department of Health's Data Linkage Branch and analysed by the research team. These administrative data are collected on children from birth to age four (and their families) and include the Child Headline Indicators, Midwives Notification System, Preschool Collection, the Ages and Stages Questionaire plus Australian Early Development Census (AEDC) data.

Module 3: Individual/ Family Mechanisms Impact Evaluation --> To determine (based on changing practices and exposure to community supports, programs, and services; and using a range of individual and group qualitative methods) which activities touched whom and in what contexts, by measuring changes in mechanisms hypothesised to mediate child development, health, and learning, i.e.: a) Parenting practices; b) Family functioning; c) Service access, quality, and use; and d) Collaboration between services. Data for this module will be collected via 15-20 minute surveys of parent/caregivers (conducted at three-year intervals by child health professionals when parent/caregivers attend universal health checks with their children from birth to age four), surveys of service providers administered by the research team at three-year intervals, and through focus groups with volunteer parents to pursue emerging lines of enquiry that arise from survey findings (not being assessed as part of the current registration record).

Module 4: Community Mechanisms/Impact -> To measure the process of community capacity-building (not being assessed as part of the current registration record).

Module 5: Lessons Learnt --> To describe the process of operationalisation of the EYI by the partner organisations in each of the four communities and how findings are translated into scalable policy, if appropriate (not being assessed as part of the current registration record).

Module 6: Economic Evaluation --> to measure the cost-effectiveness of EYI as an approach by comparing the program costs with outcomes achieved (not being assessed as part of the current registration record).
Intervention code [1] 318597 0
Not applicable
Comparator / control treatment
WA communities that are not taking part in the Initiative but have sufficiently similar demographics to EYI partner communities will be identified to function as control/comparison sites for Module 2 (Outcomes).
Control group
Active

Outcomes
Primary outcome [1] 325122 0
Proportion of children developmentally vulnerable on one or more domains of the Australian Early Developmental Census
Timepoint [1] 325122 0
The AEDC is collected nationally every 3 years. The EYI analysis will draw on AEDC data collected in 2018, 2021, 2024, and 2027.
Primary outcome [2] 325123 0
Composite child development at 24 months as assessed using the Ages and Stages Questionnaire (ASQ-3) combined with the Ages and Stages Questionnaire: Social Emotional (ASQ-SE)
Timepoint [2] 325123 0
Cross-sectional data will be gathered during the first six months of 2022, 2025, and 2028.
Primary outcome [3] 325126 0
Kindergarten attendance rates - proportion of four year old children in target communities who attend school for 90% or more of the Kindergarten sessions for which they are enrolled. These data will be accessed via data custodians at the WA Department of Education which collates these school attendance data from all public schools on a daily basis via its School Information and Data System.
Timepoint [3] 325126 0
Cross-sectional data will be gathered during the first six months of 2021, 2024, and 2027.
Secondary outcome [1] 386939 0
Low birthweight: Percentage of live born infants with a birthweight of less than 2,500 grams. These data will be sourced via administrative data (e.g.: Child Headline Indicators, Midwives Notification System.) and data-linkage approvals procedures.
Timepoint [1] 386939 0
Cross-sectional data will be gathered during the first six months of 2021, 2024, and 2027.
Secondary outcome [2] 386940 0
Breastfeeding: Percentage of infants exclusively breastfed to around 4 months of age. These data will be sourced via administrative data (e.g.: Child Headline Indicators, Midwives Notification System.) and data-linkage approvals procedures.
Timepoint [2] 386940 0
Cross-sectional data will be gathered during the first six months of 2022, 2025, and 2028.
Secondary outcome [3] 386941 0
Percentage of children on the Australian Immunisation Register (AIR) who are fully immunised at 2 years of age
Timepoint [3] 386941 0
cross-sectional data will be gathered during the first six-months of 2022, 2025, and 2028
Secondary outcome [4] 386942 0
Proportion of children identified as requiring referral for dental/oral health issues through screening at school entry (e.g.: due to gum disease or dental decay when the start full-time school.
Timepoint [4] 386942 0
Cross-sectional data will be gathered during the first six months of 2022, 2025, and 2028.
Secondary outcome [5] 386943 0
Proportion of children identified as requiring referral for otitis media through screening when they commence full-time school.
Timepoint [5] 386943 0
Cross-sectional data will be gathered during the first six months of 2022, 2025, and 2028.

Eligibility
Key inclusion criteria
all children aged 0 to 4 years, within defined EYI target communities, and comparison communities.
Minimum age
0 Years
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Families whose babies/children have died or who have a biological parent who has died will be excluded from the study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Data analysis will be conducted between each partner community and its comparison communities, and within each partner community to ascertain differences in baseline and follow-up administrative and service data. Due to the small sample sizes within some partner communities (e.g., in the Central Great Southern (CGS), there are approximately 120 births per year), data on all EYI communities may be aggregated and compared to all aggregated comparison communities.

Analysis includes:

Within the partner community:
Baseline descriptive analysis of the aggregated administration and service usage data, with approximately three-yearly comparisons over the length of the EYI to determine any significant changes in administration data over time for children aged 0-4 years and their parents/carers.

Between each partner and its comparison community/ies:
Baseline descriptive analysis of aggregated administration and service usage data of the partner and comparison communities, with biennial comparisons over the length of the EYI.

Between all partner and all comparison communities:
Baseline descriptive analysis of aggregated administration and service usage data of the partner and comparison communities, with biennial comparisons over the length of the EYI.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/04/2021
Actual
Date of last participant enrolment
Anticipated
31/12/2028
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
30000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 306676 0
Government body
Name [1] 306676 0
Department of Communities
Country [1] 306676 0
Australia
Funding source category [2] 306731 0
Charities/Societies/Foundations
Name [2] 306731 0
Minderoo Foundation
Country [2] 306731 0
Australia
Funding source category [3] 306732 0
Government body
Name [3] 306732 0
Department of Health, WA
Country [3] 306732 0
Australia
Funding source category [4] 306734 0
Government body
Name [4] 306734 0
Department of Education
Country [4] 306734 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Telethon Kids Institue
Address
15 Hospital Avenue, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 307820 0
None
Name [1] 307820 0
NA
Address [1] 307820 0
NA
Country [1] 307820 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306856 0
Child and Adolescent Health Service (CAHS) HREC
Ethics committee address [1] 306856 0
Ethics committee country [1] 306856 0
Australia
Date submitted for ethics approval [1] 306856 0
15/02/2021
Approval date [1] 306856 0
Ethics approval number [1] 306856 0
Ethics committee name [2] 306904 0
Western Australian Aboriginal Health Ethics Committee (WAAHEC)
Ethics committee address [2] 306904 0
Ethics committee country [2] 306904 0
Australia
Date submitted for ethics approval [2] 306904 0
15/02/2021
Approval date [2] 306904 0
Ethics approval number [2] 306904 0
Ethics committee name [3] 306905 0
Department of Health HREC
Ethics committee address [3] 306905 0
Ethics committee country [3] 306905 0
Australia
Date submitted for ethics approval [3] 306905 0
01/03/2021
Approval date [3] 306905 0
Ethics approval number [3] 306905 0

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

Contacts
Principal investigator
Name 105246 0
Prof Donna Cross
Address 105246 0
Telethon Kids Institute
15 Hospital Avenue, Nedlands, WA 6009
Country 105246 0
Australia
Phone 105246 0
+61 419 926 070
Fax 105246 0
Email 105246 0
[email protected]
Contact person for public queries
Name 105247 0
Rosemary Cahill
Address 105247 0
Telethon Kids Institute
15 Hospital Avenue, Nedlands, WA 6009
Country 105247 0
Australia
Phone 105247 0
+61 8 6319 1505
Fax 105247 0
Email 105247 0
[email protected]
Contact person for scientific queries
Name 105248 0
Rosemary Cahill
Address 105248 0
Telethon Kids Institute
15 Hospital Avenue, Nedlands, WA 6009
Country 105248 0
Australia
Phone 105248 0
+61 8 6319 1505
Fax 105248 0
Email 105248 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.