Trial Review

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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] 259870 0
N/A
Universal Trial Number (UTN)
Trial acronym
EYERP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attachment Disorders 265458 0
Developmental Delay 265459 0
Infant and Child Mental Health problems 265460 0
Condition category
Condition code
Mental Health 265615 265615 0 0
Learning disabilities
Public Health 265926 265926 0 0
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] 264292 0
Treatment: Other
Intervention code [2] 264513 0
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] 262399 0
Successful transition into primary school as measured by the Woodcock Johnson Literacy and Numeracy Scales; the Devereaux Early Childhood Assessment.
Timepoint [1] 262399 0
6 Months post entry to Prep year at Primary School.
Secondary outcome [1] 273701 0
Socio-emotional development, cognitive and language developmental outcomes assessed using standardised developmental assessments and parent and teacher questionnaires.
Timepoint [1] 273701 0
1, 2, and 3 years post randomisation
Secondary outcome [2] 273702 0
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] 273702 0
1, 2, and 3 years post randomisation
Secondary outcome [3] 273703 0
More sustained participation in early childhood care and education; assessed using parent and teacher questionnaires.
Timepoint [3] 273703 0
1, 2, and 3 years post randomisation
Secondary outcome [4] 273704 0
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] 273704 0
1, 2, and 3 years post randomisation
Secondary outcome [5] 273705 0
Attuned parental caregiving assessed by standardised assessment of parent-child interaction.
Timepoint [5] 273705 0
1, 2, and 3 years post randomisation
Secondary outcome [6] 273706 0
Cost-benefit analysis of the EYEP using outcome data and data on service usage, educational attainment, etc.
Timepoint [6] 273706 0
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?
No
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
90
Accrual to date
Final
147
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 264747 0
Charities/Societies/Foundations
Name [1] 264747 0
Children's Protections Society
Country [1] 264747 0
Australia
Funding source category [2] 264749 0
Charities/Societies/Foundations
Name [2] 264749 0
Ian Potter Foundation
Country [2] 264749 0
Australia
Funding source category [3] 264750 0
Charities/Societies/Foundations
Name [3] 264750 0
Myer Family Foundation
Country [3] 264750 0
Australia
Funding source category [4] 264751 0
Charities/Societies/Foundations
Name [4] 264751 0
Ross Trust
Country [4] 264751 0
Australia
Funding source category [5] 264752 0
Charities/Societies/Foundations
Name [5] 264752 0
Pratt Foundation
Country [5] 264752 0
Australia
Funding source category [6] 264754 0
Government body
Name [6] 264754 0
VicHealth
Country [6] 264754 0
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] 263873 0
University
Name [1] 263873 0
University of Melbourne, Faculty of Economics
Address [1] 263873 0
Parkville
Victoria 3010
Country [1] 263873 0
Australia
Secondary sponsor category [2] 264095 0
University
Name [2] 264095 0
University of Melbourne, Department of Paediatrics
Address [2] 264095 0
Royal Children's Hospital, Parkville
Victoria 3052
Country [2] 264095 0
Australia
Secondary sponsor category [3] 264096 0
University
Name [3] 264096 0
Melbourne Institute of Applied Economic and Social Research
Address [3] 264096 0
Parkville
Victoria 3010
Country [3] 264096 0
Australia
Other collaborator category [1] 251902 0
Individual
Name [1] 251902 0
Dr Anne Kennedy
Address [1] 251902 0
Charles Sturt University
399 Lonsdale Street Melbourne VIC 3000
Country [1] 251902 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266733 0
Behavioural and Social Sciences Human Ethics Sub-Committee University of Melbournee
Ethics committee address [1] 266733 0
Ethics committee country [1] 266733 0
Australia
Date submitted for ethics approval [1] 266733 0
Approval date [1] 266733 0
01/10/2010
Ethics approval number [1] 266733 0
1034236

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

Contacts
Principal investigator
Name 32398 0
A/Prof Brigid Jordan
Address 32398 0
University of Melbourne
Professor Jeff Borland, FBE Building (Former ICT), Parkville
VICTORIA 3052
Country 32398 0
Australia
Phone 32398 0
+61 408 899 271
Fax 32398 0
Email 32398 0
[email protected]
Contact person for public queries
Name 15645 0
Nichola Coombs
Address 15645 0
CPS
70 Altona St
West Heidelberg
Victoria, 3081
Country 15645 0
Australia
Phone 15645 0
+61 0438395506
Fax 15645 0
+61 3 9459 8885
Email 15645 0
[email protected]
Contact person for scientific queries
Name 6573 0
Associate Professor Brigid Jordan
Address 6573 0
University of Melbourne, Department of Paediatrics
Royal Children's Hospital, Parkville
Victoria 3052
Country 6573 0
Australia
Phone 6573 0
+61 9345 4144
Fax 6573 0
Email 6573 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseImproving lifetime trajectories for vulnerable young children and families living with significant stress and social disadvantage: the early years education program randomised controlled trial.2014https://dx.doi.org/10.1186/1471-2458-14-965
N.B. These documents automatically identified may not have been verified by the study sponsor.