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Trial registered on ANZCTR

Registration number

ACTRN12611000768998

Ethics application status

Approved

Date submitted

28/03/2011

Date registered

22/07/2011

Date last updated

25/09/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Early Years Education Research Project

Scientific title

Vulnerable children aged 0-3 years, case managed by child protection or family services will attend 25 hours/week of enhanced attachment focussed childcare for at least three years and be compared with vulnerable children aged 0-3 years case managed by child protection or family services receiving case management only.

Secondary ID [1]

N/A

Universal Trial Number (UTN)

Trial acronym

EYERP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Attachment Disorders

Developmental Delay

Infant and Child Mental Health problems

Condition category

Condition code

Mental Health

Learning disabilities

Public Health

Other public health

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Children who participate in Early Years Education Program (EYEP) will receive at least 25 hours over five days of high-quality educational childcare from (age of entry 0-3 years old) for 3 years. Distinctive features of the EYEP include: high staff:child ratio (1:3 for children under 3, and 1:6 for 3 years and older when those children reach 3 years of age and older during their participation in the program); therapeutic interventions of attachment-focused care giving and high quality responsive care practices combined with intentional teaching strategies including the Abecedarian Project learning games, regular meetings incorporating parents and family support/child protection workers and the Early Years Educators to identify, with parents, the goals and aims they would like to achieve.

Intervention code [1]

Treatment: Other

Intervention code [2]

Other interventions

Comparator / control treatment

Children in control group will continue to receive community based family services (usual care). As this is usual care it is not being delivered by the research program and there are no requirements or prohibitions in respect to what services families decide to use. Families are free to use child care services and early years education services as they usually would.

Control group

Active

Outcomes

Primary outcome [1]

Successful transition into primary school as measured by the Woodcock Johnson Literacy and Numeracy Scales; the Devereaux Early Childhood Assessment.

Timepoint [1]

6 Months post entry to Prep year at Primary School.

Secondary outcome [1]

Socio-emotional development, cognitive and language developmental outcomes assessed using standardised developmental assessments and parent and teacher questionnaires.

Timepoint [1]

1, 2, and 3 years post randomisation

Secondary outcome [2]

Attachment security in children's relationships with their primary care givers as assessed by the laboratory-based Strange Situation Procedure at baseline, then Story Stem Attachment Porcedure at subsequent timepoints.

Timepoint [2]

1, 2, and 3 years post randomisation

Secondary outcome [3]

More sustained participation in early childhood care and education; assessed using parent and teacher questionnaires.

Timepoint [3]

1, 2, and 3 years post randomisation

Secondary outcome [4]

Physical and mental health; mental health assessed by standardised assessments with child and parent questionnaires; physical health by parent questionaire and child health questionnaire.

Timepoint [4]

1, 2, and 3 years post randomisation

Secondary outcome [5]

Attuned parental caregiving assessed by standardised assessment of parent-child interaction.

Timepoint [5]

1, 2, and 3 years post randomisation

Secondary outcome [6]

Cost-benefit analysis of the EYEP using outcome data and data on service usage, educational attainment, etc.

Timepoint [6]

4 years post randomisation

Eligibility

Key inclusion criteria

Children eligible for participation will be aged 0 to 3 years, and assessed as having two or more risk factors (as identified in the Department of Human Services (DHS) Best Interest Practice Guidelines and may include factors such as teenage parents, parental substance abuse, parental mental health difficulties, presence of family violence). Referrals of potential participants will be made by Family Support Caseworkers from clients of child welfare services accessed through Child FIRST (Family Information Referral Support Team) and Child Protection (within Department of Human Services). Referrals will be from within the north-east catchment in Melbourne where CPS is located. Referring agencies will advise the family of the child being referred that there are a limited number of places available in EYEP and that allocation is being done by randomization.

Minimum age

0 Years

Maximum age

3 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Age of entry into the study is 0-3 years and the dose of intervention is 3 years; therefore some children will be ages 3-6 during their participation in the program.

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)

All families whose child is referred will be informed that there is a research and evaluation project being conducted to measure the efficacy of this new service. A field-based researcher will then contact family to organize a time to meet to explain the study using the Plain Language Statement and invite them to consent to be involved.

Once families consent to taking part in the research, the field-based researcher contacts the off-site researcher who has the sealed opaque envelopes and is then informed of the allocation of tthat child into an EYEP participation group (treatment) or regular family support group (control). Families are then informed which group they have been assigned to.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

STATA block randomisation program with variable block size.

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

Active, not recruiting

Date of first participant enrolment

Anticipated

1/02/2011

Actual

10/01/2011

Date of last participant enrolment

Anticipated

Actual

21/01/2016

Date of last data collection

Anticipated

1/06/2020

Actual

Sample size

Target

Accrual to date

Final

147

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Children's Protections Society

Address [1]

70 Altona St
West Heidelberg
Vic 3081

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Ian Potter Foundation

Address [2]

Level 3, 111 Collins Street

Melbourne VIC 3000

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Myer Family Foundation

Address [3]

17 Bennetts Lane
Melbourne, Victoria 3000

Country [3]

Australia

Funding source category [4]

Charities/Societies/Foundations

Name [4]

Ross Trust

Address [4]

7th Floor, 24 Albert Road,
South Melbourne,
Victoria, 3205

Country [4]

Australia

Funding source category [5]

Charities/Societies/Foundations

Name [5]

Pratt Foundation

Address [5]

Pratt Foundation
PO Box 19464
Southbank VIC 3006

Country [5]

Australia

Funding source category [6]

Government body

Name [6]

VicHealth

Address [6]

Ground Floor
15?31 Pelham St (PO Box 154)
Carlton South VIC 3053

Country [6]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Children's Protection Society

Address

70 Altona St
West Heidelberg
Vic 3081

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Melbourne, Faculty of Economics

Address [1]

Parkville
Victoria 3010

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

University of Melbourne, Department of Paediatrics

Address [2]

Royal Children's Hospital, Parkville
Victoria 3052

Country [2]

Australia

Secondary sponsor category [3]

University

Name [3]

Melbourne Institute of Applied Economic and Social Research

Address [3]

Parkville
Victoria 3010

Country [3]

Australia

Other collaborator category [1]

Individual

Name [1]

Dr Anne Kennedy

Address [1]

Charles Sturt University
399 Lonsdale Street Melbourne VIC 3000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Behavioural and Social Sciences Human Ethics Sub-Committee University of Melbournee

Ethics committee address [1]

University of Melbourne
Parkville 3010
Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/10/2010

Ethics approval number [1]

1034236

Summary

Brief summary

This project will undertake a randomised evaluation of an intervention for socially disadvantaged children, the Early Years Education Program (EYEP).  EYEP is a new program being offered by the Children’s Protection Society (CPS).  The project will examine effects of program participation on outcomes such as children’s cognitive, speech, language and emotional development, their health and school readiness, and on the parent-child relationship, and parents’ health and community participation. 

The EYEP will provide enrolled children with at least 25 hours per week of enriched centre based child care and education for three years (or until school age).  Children must be less than 3 years of age at the time of their initial enrolment into EYEP.  Key features of this program are high staff:child ratios, qualified staff, therapeutic interventions with the child and family, integration with family support services, and a focus on building alliances with parents to sustain their child’s participation in child care.  

Referrals of children eligible for enrolment in EYEP will be from clients of child welfare services including family casework services accessed through Child FIRST (Family Information Referral Support Team) and Child Protection. Children eligible for participation will be aged less than 3 years at referral, and assessed as having experienced at least two identified risk factors such as family violence, parental mental health problems, or parental drug and alcohol use.
The referred group of children who are eligible for participation in EYEP will be randomly assigned between a treatment group who will be enrolled in the EYEP and a control group who will receive ‘usual care’.  The trial will involve data collection standardized questionnaires completed by parents and child care staff, interviews with parents, standardized assessments (for example, cognitive functioning), and observation of child behaviour in the early child care centre classroom and with parents.  This will occur over a three year period – baseline and then at yearly intervals.  
The importance of the project derives from its potential contribution to knowledge of how enhanced childcare might contribute to improved social and educational outcomes for children from highly disadvantaged backgrounds.  Currently fewer than 16% of Child FIRST clients in the north eastern region attend child care or kindergarten despite early child care and education services being a potential resource for children at risk.  To our knowledge this will be the first randomised trial of an early childhood intervention in Australia.

Trial website

www.eyerp.org

Trial related presentations / publications

 Borland, J., Clancy, T., Coombs, N., Cotter, K., Hill, A., Jordan, B., Kennedy, A. (2016 IN PRESS) Changing the Trajectory of Children’s Lives: Research and Advocacy. In J. Page & C. Tayler (Eds.) Teaching and Learning in the Early Years. Cambridge University Press.

 Jordan, B., Tseng, Y., Coombs, N., Kennedy, A., & Borland, J (2014) Improving Life Trajectories for Vulnerable Young Children and Families Living with Significant Stress and Social Disadvantage: the early years education program randomised controlled trial. BMC Public Health 2014, 14:965.

Hill, A., Jordan, B., Coombs, N., Williams-Smith, J., Borland, J. (2011) Changing life trajectories: the early years education research project. Insights, Melbourne Business and Economics Vol. 10 pp 19-25

WA Early Childhood Education & Care Conference October 2013. Oral Paper Presentation Early Years Education Research Project; A Randomised Controlled Trial

Public notes

Contacts

Principal investigator

Name

A/Prof Brigid Jordan

Address

University of Melbourne
Professor Jeff Borland, FBE Building (Former ICT), Parkville
VICTORIA 3052

Country

Australia

Phone

+61 408 899 271

Fax

brigid.jordan@rch.org.au

Contact person for public queries

Name

Nichola Coombs

Address

CPS
70 Altona St
West Heidelberg
Victoria, 3081

Country

Australia

Phone

+61 0438395506

Fax

+61 3 9459 8885

nichola.coombs@unimelb.edu.au

Contact person for scientific queries

Name

Associate Professor Brigid Jordan

Address

University of Melbourne, Department of Paediatrics
Royal Children's Hospital, Parkville
Victoria 3052

Country

Australia

Phone

+61 9345 4144

Fax

brigid.jordan@rch.org.au

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Improving lifetime trajectories for vulnerable young children and families living with significant stress and social disadvantage: the early years education program randomised controlled trial.	2014	https://dx.doi.org/10.1186/1471-2458-14-965

N.B. These documents automatically identified may not have been verified by the study sponsor.

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