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Trial registered on ANZCTR


Registration number
ACTRN12621001140842
Ethics application status
Approved
Date submitted
28/05/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Good Start in Life for Young Children: Investigating the impact of place-based interventions for young children at risk of developmental vulnerability
Scientific title
A Good Start in Life for Young Children: Investigating the impact of place-based interventions on the health and wellbeing of young children at risk of developmental vulnerability
Secondary ID [1] 304301 0
Pure Award ID – 42611725
Universal Trial Number (UTN)
U1111-1268-7973
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inadequate nutrition 322547 0
Impaired speech development 322548 0
Impaired physical development 322552 0
Impaired social and emotional regulation 322586 0
Condition category
Condition code
Public Health 319762 319762 0 0
Health service research
Public Health 319763 319763 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Education and Training – In the ACT there is an unmet need for the delivery of occupational therapy and speech pathology services for disadvantaged, low income, and refugee families. The study is a pre-test-post-test non-equivalent groups design. This arm of interventions will be provided in consultation with the services within the intervention suburbs. An individual needs analysis will be conducted to assess the appropriateness of each intervention to ensure targeted service delivery. Additionally, the availability of intervention programs will be considered across the length of the trial. The University of Canberra runs a student led allied health service from its University Health Hub. Allied health services will be delivered as ‘outreach services’ to access vulnerable children and families in the community. Service delivery will focus on early speech and language development, attention, concentration, and readiness to learn, gross and fine motor skills, social skills, and nutrition. Services will be delivered at local playgroups, community centres, preschools and early childhood, education and care services by students completing their Work Integrated Learning (WIL) in their undergraduate or post-graduate allied health degrees supervised by Clinical Educators funded by the Good Start in Life project. Students are training in their specialities through their degrees and will be trained in the below programs as needed, however our Clinical Educators are trained in the programs. Individuals and small groups of children and families as well as early childhood educators and support workers will be involved in this arm of the intervention that will be delivered face-to-face. The education and training programs offered (examples of specific programs include, the Hanen Centre's Learning Language and Loving It™, Read It Again and Parents as Teachers) will help with language development, literacy skills, promoting social interaction, play and participating in home, community and early learning environments. The programs will be offered at least once per week in the included services for approximately 2 hours per session, The programs will be delivered to children aged 2 – 5 years old and will run for the duration of the project, which is anticipated to be 3 years with the possibility of extension, pending additional funding. Sign in sheets will be used for each program as a strategy to monitor adherence to the interventions.

Arm 2: Good Start in Active Play – The Good Start in Life Active Play program (based on the Kids at Play Active Play ACT Department of Health program) will help train early childhood educators and health professionals feel confident to promote active play and teach fundamental movement skills to children aged three to five. Training by WIL University of Canberra allied health students includes practical ‘hands on’ skills sessions to assist educators to apply the learnings in their setting. Types of play encouraged will include structured and unstructured play, indoor and outdoor play, playing alone or in a group. Active play encourages fine and gross motor skill development, socialisation, confidence, self-esteem, thinking skills and emotional regulation. This program enables services to encourage children to engage in the recommended 25 minutes of active play per day and facilitate free play opportunities. The training will occur within the early childhood, education and care services, preschool, and playgroups. Each training session will run for approximately 2-hour blocks across 4 sessions and will run for the duration of the project, which is anticipated to be 3 years with the possibility of extension, pending additional funding. Sign in sheets will be used for each program as a strategy to monitor adherence to the interventions.

Arm 3: Loose Parts Play ‘Pop Ups’ – Loose Parts Play is a type of play that supports invention, divergent thinking, problem solving, helps to develop and refine gross motor-skills and encourages children to challenge themselves and explore their physical abilities in a safe environment. These activities will be provided in public spaces and places, in local neighbourhood areas, playgroups and pre-schools. The activities involving unstructured play with loose parts will be facilitated by allied health degree students completing their WIL. The Good Start in Life project will supply the instruments used in the Loose Parts Play ‘pop ups’ that will be tailored to the specific environment. The ‘pop ups’ will be offered at least once per week in the intervention suburbs for approximately 2 hour per session and will run for the duration of the project, which is anticipated to be 3 years the possibility of extension, pending additional funding. The ‘pop ups’ will be delivered in parks and recreation areas for children and family members to participate in, as such there will be no age limit. Examples of themes for each session will vary, examples include, animals (create a farm), music (make musical instruments) etc. Sign in sheets will be used for each program as a strategy to monitor adherence to the interventions.

Arm 4: Family Liaison Coordinator – Most children and their caregivers encounter a myriad of systems throughout the course of their child’s development. For families who face complex challenges and multiple disadvantages in their everyday lives, navigating the different health, education and community sectors and multiple service networks can be extremely challenging. The Family Liaison Coordinator employed by the Good Start in Life project for the duration of the project - which is anticipated to be 3 years with the possibility of extension, pending additional funding - has a background in the early childhood sector and will work with families and services across our intervention sites to bridge systems and services by assisting families in obtaining referrals or appointments to health specialists where needed. The Family Liaison Coordinator will be contactable through email and phone to facilitate continuity of care for children, parents and caregivers and support and educate the professionals that they work alongside. Additionally, the Family Liaison Coordinator will be available within services in the intervention suburbs at pre-arranged, advertised times to facilitate better connections between professionals, services, and sectors improving service integration.

Arm 5: Service Integration Measure – To gauge the current level of integration between health, education, and social services for children and to monitor changes to the network over time, representatives from early childhood education and care centres, playgroups and preschools will be asked to participate in this research. The research team will identify which services are currently working together. This will be achieved through the completion of an adapted Human Services Integration Tool (Browne et. al., 2007) by representatives from education centres in the identified intervention suburbs. If any collaborations are identified, the research team will then contact the collaborating services and request completion of the Collaboration Rubric Tool to determine the scope and depth of the integration. The tools will take 10 – 20 minutes to complete online. Finally, the participants will be invited to complete an interview conducted by the research team to further understand the current level of integration the centre has with other services, what collaboration means to them, and the barriers and facilitators to collaboration. The interviews will range from 30 – 60 minutes, one-on-one, face-to-face or videoconferencing and will be recorded and analysed for qualitative data by the research team with consent.
Intervention code [1] 320639 0
Prevention
Intervention code [2] 320640 0
Lifestyle
Intervention code [3] 320974 0
Behaviour
Comparator / control treatment
The control group is the Tuggeranong District Area and no treatment or intervention will occur within this district, this area will receive ‘usual care’. The term ‘usual care’ is defined for the purpose of this study as the provision of early childhood education and care services without the study implementing interventions in the control group.
Control group
Active

Outcomes
Primary outcome [1] 327622 0
Any change assessed independently in the number of children identified as developmentally vulnerable in the domain of physical health and wellbeing in the Belconnen District Area identified by the 2024 Australian Early Development Census data.
Timepoint [1] 327622 0
Baseline and 3 years post implementation commencement.
Primary outcome [2] 327623 0
Any change assessed independently in the number of children identified as developmentally vulnerable in the domain of social competence in the Belconnen District Area identified by the 2024 Australian Early Development Census data.
Timepoint [2] 327623 0
Baseline and 3 years post implementation commencement.
Primary outcome [3] 328672 0
Any change assessed independently in the number of children identified as developmentally vulnerable in the domain of emotional maturity in the Belconnen District Area identified by the 2024 Australian Early Development Census data.
Timepoint [3] 328672 0
Baseline and 3 years post implementation commencement.
Secondary outcome [1] 395969 0
Primary outcome: Any change assessed independently in the number of children identified as developmentally vulnerable in the domain of language and cognitive skills in the Belconnen District Area identified by the 2024 Australian Early Development Census data.
Timepoint [1] 395969 0
Baseline and 3 years post implementation commencement.
Secondary outcome [2] 399916 0
Primary outcome: Any change assessed independently in the number of children identified as developmentally vulnerable in the domain of communication skills and general knowledge skills in the Belconnen District Area identified by the 2024 Australian Early Development Census data.
Timepoint [2] 399916 0
Baseline and 3 years post implementation commencement.
Secondary outcome [3] 399918 0
Primary outcome: Any change in the uptake of referrals and service planning across services assessed by the Human Services Integration Measure tool (Browne et. al. 2004).
Timepoint [3] 399918 0
Baseline and yearly for 3 years post implementation commencement.

Eligibility
Key inclusion criteria
Nine suburbs were selected using Australian Early Development Census (AEDC) data from 2012 to 2018. Suburbs were considered for the intervention if they had shown a worsening trend in vulnerability in at least three domains and the ‘vulnerable in one or more domains’ category. Using these criteria and on the ground knowledge from local stakeholders and service providers to confirm areas of intervention, the services invited to participate in the study were selected if they met certain criteria. First, the service must be located within one of the nine intervention suburbs or belong to one of the partner organisations and be located within the Belconnen District Area. Second, the service must target children aged between 0 and 5. The service must also pass a risk assessment and have educators that are willing and able to complete the programmes and consent to data collection and a recorded follow-up interview.

Additionally, six ‘control’ suburbs located in the Tuggeranong District Area were selected for inclusion in the study and matched on the same AEDC data for the intervention area. Once the intervention and control suburbs were identified children aged between 0 and 5, their parents or caregivers and educators at participating services in the intervention suburbs are included as participants in the study.
Minimum age
0 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Suburbs located outside of the intervention and control sites (Belconnen and Tuggeranong District Areas) will not be recruited to participate in the study. However, children and families from outside the intervention and control site areas may access the interventions, data collection and analysis will only be collected and reported on with regards to the primary outcome measures.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Our sample size calculation is based on the AEDC ‘critical difference estimates for communities’. We will focus the intervention on those suburbs in the two poorest performing districts (Belconnen and Tuggeranong District Areas) with the highest proportions of children with at least one early development indices domain in the
developmentally vulnerable category at the most recent census. For example, based on 2018 census results, ~40% of this sample have been classified as developmentally ‘at risk’, i.e. falling significantly behind their peers, and could benefit from early intervention. We anticipate that approximately half of this number, ~250-300 children, will be required to show critical difference i.e. significant change).

Testing for statistically significant differences in children’s early development indices will be based on the critical difference approach developed for the AEDC by Gregory and Brinkman (2016). The Gregory and Brinkman (2016, p.13) report provides the technical details to determine “how big” a difference (%) needs to be in the EDI results between two different time points or two different areas to be considered statistically significant. The method allows for the expected sample to sample variation and typical measurement error associated with the sort of data collected in the AEDC. Current versions of the methodology allow us to compare two point-estimates, either across time or between neighbourhoods, of the selected index.

Reference:
Gregory T, Brinkman S. Exploring change in the Australian version of the Early Development Instrument: The estimation of a critical difference for the “vulnerable”, “at risk” and “on track” categories. Adelaide, Australia: Telethon Kids Institute; 2016.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2021
Date of last participant enrolment
Anticipated
1/03/2022
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
300
Accrual to date
150
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 34124 0
2614 - Aranda
Recruitment postcode(s) [2] 34126 0
2614 - Hawker
Recruitment postcode(s) [3] 34127 0
2614 - Scullin
Recruitment postcode(s) [4] 34128 0
2617 - Bruce
Recruitment postcode(s) [5] 34129 0
2617 - Evatt
Recruitment postcode(s) [6] 34130 0
2617 - Mckellar
Recruitment postcode(s) [7] 34131 0
2615 - Latham
Recruitment postcode(s) [8] 34132 0
2615 - Charnwood
Recruitment postcode(s) [9] 34203 0
2615 - Fraser

Funding & Sponsors
Funding source category [1] 308675 0
Government body
Name [1] 308675 0
Australian Government Department of Health, Medical Research Future Fund
Country [1] 308675 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Health Research Institute, Building 23, University Drive, Bruce, ACT, 2601
Country
Australia
Secondary sponsor category [1] 309610 0
None
Name [1] 309610 0
Address [1] 309610 0
Country [1] 309610 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308597 0
University of Canberra, Human Research Ethics Committee
Ethics committee address [1] 308597 0
Ethics committee country [1] 308597 0
Australia
Date submitted for ethics approval [1] 308597 0
07/07/2020
Approval date [1] 308597 0
10/07/2020
Ethics approval number [1] 308597 0
20202161

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

Contacts
Principal investigator
Name 111274 0
Prof Rachel Davey
Address 111274 0
Health Research Institute
University of Canberra
11 Kirninari St
Bruce ACT 2617
Country 111274 0
Australia
Phone 111274 0
+61 2 6201 5131
Fax 111274 0
Email 111274 0
[email protected]
Contact person for public queries
Name 111275 0
Vicky Saunders
Address 111275 0
Health Research Institute
University of Canberra
11 Kirninari St
Bruce ACT 2617
Country 111275 0
Australia
Phone 111275 0
+61 2 6201 8737
Fax 111275 0
Email 111275 0
[email protected]
Contact person for scientific queries
Name 111276 0
Vicky Saunders
Address 111276 0
Health Research Institute
University of Canberra
11 Kirninari St
Bruce ACT 2617
Country 111276 0
Australia
Phone 111276 0
+61 2 6201 8737
Fax 111276 0
Email 111276 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
Consent to share individual participant data publicly has not been sought.


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
SourceTitleYear of PublicationDOI
Dimensions AIA Good start in life: Effectiveness of integrated multicomponent multisector support on early child development—Study protocol2022https://doi.org/10.1371/journal.pone.0267666
N.B. These documents automatically identified may not have been verified by the study sponsor.