Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000536460
Ethics application status
Approved
Date submitted
13/04/2016
Date registered
27/04/2016
Date last updated
10/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fostering Effective Early Learning (FEEL) study: Effect of a professional development program for early childhood educators on children's cognitive, social and self-regulatory development
Scientific title
Fostering Effective Early Learning (FEEL) study: Effect of a professional development program for early childhood educators on children's cognitive, social and self-regulatory development
Secondary ID [1] 288984 0
None
Universal Trial Number (UTN)
Trial acronym
FEEL Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early child development 298385 0
Quality of early childhood education and care provision 298435 0
Condition category
Condition code
Other 298488 298488 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Professional Development (PD) program to strengthen quality of intentional and relational pedagogy for Early Years Educators

The aim is to enhance effective practice with all children through a professional development (PD) program focused on sustained shared thinking and emotional wellbeing. The program provides opportunities to observe, discuss, practice and reflect on important attributes of the effective educator’s role, such as: engaging in high quality interactions and sustained shared thinking, developing and extending concepts, and modelling critical and reflective thinking. Links are made to appropriate frameworks including the Australian National Quality Standards (NQS) and the Australian Early Years Learning Framework (EYLF). Fundamental to each session is evidence-based understandings of how young children learn best. The program is designed to support collective participation, promoting collaborative working to gain deeper knowledge of leadership, change management, quality improvement and self-assessment.

The program covers eight content areas:
1. Research on quality in ECEC and its assessment
2. How high quality interactions, known as sustained shared thinking (SST) extend children’s development
3. The relevance of self-regulation to children’s educational success
4. The links between early language development and later literacy
5. Mathematical and scientific concept development in the early years
6. Ways to use observation, assessment of practice and planning to improve quality
7. The importance of the home learning environment (HLE) and ways to successfully engage with parents to enhance the HLE
8. The relevance of quality leadership in ECEC for children’s development and ways to introduce change in management

The PD program is delivered in three distinct phases over 9 months:

Phase 1: Intensive Professional Development (Week 1 - Week 3, delivered at each of 3 hubs)
A two-day intensive face-to-face training providing: an overview of national and international research on quality in Early Childhood Education and Care (ECEC); introduction to relevant environmental quality rating scales; coverage of key concepts and ideas to enable educators to identify areas of their practice to target for improvement; and strategies to foster language development, social and cognitive development, high quality interactions, self-regulation and working with homes.

Phase 2: Follow-up Professional Development (Week 3 - Month 3, delivered at each of 3 hubs)
Five half-day face-to-face sessions, delivered every two weeks, beginning two weeks after a hub's completion of Phase 1. These are designed to allow time for the educators to use new knowledge, understanding, approaches, etc. within their settings and to critically analyse and reflect upon impact and adapt where necessary. The sessions include time for reflection and critical analysis, as well as introduce knowledge and pedagogical content on areas not covered in Phase 1.

Phase 3: Model for sustainability (Week 3 - Month 9)
To limit staff turnover and increase the likelihood of a positive impact, there is PD support for 9 months through online modules (beginning at the end of Phase 1 and continuing for the duration of the year). Activities and resources, designed to promote staff engagement and establish an online community of educators are within modules or ‘E-books’. Each E-book combines video-streamed content with questions and text, including links to activities and a discussion forum. Staff participation and discussions feed into a learning portfolio, tracking and reflecting how their ideas about pedagogy, children, families and communities have changed .

Session Details: All sessions will be delivered at each of 3 central hubs, to ensure all centres are within 1.5 hours of the PD location. Sessions are conducted by four of the study's Principal Investigators, who are international experts and researchers in Early Years Education. All of the sessions are run as group sessions for centres most proximal to that hub.
Intervention code [1] 294470 0
Behaviour
Comparator / control treatment
The study employs a clustered randomised controlled trial design. Ninety centres with an early childhood teacher (ECT; preschool and long day care) have be selected and stratified according to pre-existing NQS criteria (i.e., working towards, meeting or exceeding national standards), location (i.e., metro, regional or rural), baseline quality ratings, service type and SEIFA. Control centres continue their usual early learning activities.
Control group
Active

Outcomes
Primary outcome [1] 297972 0
The primary outcome is children's early language development, as indexed by performance on selected child assessments. The battery of child measures has been selected to include outcomes prominently but not exclusively positioned within the Early Years Learning Framework (EYLF; e.g., EYLF is weak on certain aspects such as content of curriculum e.g., mathematical and scientific thinking and learning yet these areas are important for school readiness and articulation with the Australian curriculum in NSW), as well as their foundational role in child development as established by previous research. In total, this will involve 40-50 minutes of direct assessment per child (split into two sessions) and 10 minutes of educator time per child (i.e., 3.3 hours of educator time per centre, spread across three weeks). The primary outcome amongst these is:

1. Language (Pre-Post): The Verbal Comprehension subtest (British Ability Scales, 2011) is a measure of the receptive language (comprehension) ability of the child, and takes 10-15 minutes to administer.
Timepoint [1] 297972 0
Baseline and 9 months later at the end of the intervention
Primary outcome [2] 298024 0
1. Language (Pre-Post): The Early Years Toolbox Expressive Vocabulary Assessment (Melhuish & Howard, 2016) is our assessment of expressive vocabulary to complement the receptive language measure and takes 5 minutes to administer.
Timepoint [2] 298024 0
Baseline and 9 months later at the end of the intervention
Secondary outcome [1] 322811 0
2. Numeracy (Pre-Post): The British Ability Scales Early Number Concepts (3rd ed.), which takes about 10 minutes to complete, assessed abilities related to numerical concepts, relative quantity, numeral identification, number combinations, sequence and verbal counting.
Timepoint [1] 322811 0
Baseline and 9 months later at the end of the intervention
Secondary outcome [2] 322942 0
2. Numeracy (Pre-Post): The Early Numeracy Assessment supplements our other numeracy assessment by assessing one-to-one counting, counting subsets, number comparison, number order and verbal counting.
Timepoint [2] 322942 0
Baseline and 9 months later at the end of the intervention
Secondary outcome [3] 322944 0
3. Social Development (Pre-Post): Social development will be assessed by educator-report Strengths & Difficulties Questionnaire (SDQ), with subscales of prosocial behaviours, peer problems, hyperactivity, emotional problems and conduct problems.
Timepoint [3] 322944 0
Baseline and 9 months later at the end of the intervention
Secondary outcome [4] 322945 0
4. Self-Regulation (Pre-Post): Self-Regulation will be assessed using educator-reports on the Child Self-Regulation and Behaviour Questionnaire (CSBQ; Melhuish & Howard, 2016), with subscales on cognitive, emotional and behavioural self-regulation, antisocial behaviour, prosocial behaviour, sociability and anxiety/internalising.
Timepoint [4] 322945 0
Baseline and 9 months later at the end of the intervention
Secondary outcome [5] 322946 0
Observational ratings of the quality of provision in centres will be via two measures, one of which is the Early Childhood Environment Rating Scale – Extended (ECERS-E) scale, which use concepts central to developmental psychology, early childhood education and pedagogy.

ECERS-E measures quality of the curricula, environment and pedagogy in language and literacy, maths and number, science and environment and diversity.
Timepoint [5] 322946 0
Early baseline (4 months pre-intervention) and 9 months post-intervention, to equate time of year
Secondary outcome [6] 322947 0
The second measure for observational ratings of the quality of provision in centres is the Sustained Shared Thinking and Emotional Well-being (SSTEW) scale, which use concepts central to developmental psychology, early childhood education and pedagogy.

The SSTEW scale is designed to consider practice that supports children aged 2 to 5 in developing skills in sustained shared thinking and emotional wellbeing. The scale consists of the following 5 subscales: (1) building trust, confidence and independence; (2) social and emotional well-being; (3) supporting and extending language and communication; (4) supporting learning and critical thinking; and (5) assessing learning and language.
Timepoint [6] 322947 0
Early baseline (4 months pre-intervention) and 9 months post-intervention, to equate time of year

Eligibility
Key inclusion criteria
90 centres have been recruited (approx. ~25% community preschools and ~75% long day care centres) from the Greater Western Sydney, Metropolitan South-Western Sydney, the Illawarra-Shoalhaven region, selected areas of Western NSW and Central Coast. The centres were selected to ensure representation across National Quality Standards ratings (approximately equal numbers of working towards, meeting, exceeding), geographic location (30 metro centres and 60 regional + remote centres) and low to moderate socioeconomic areas (Deciles 1-8, according to SEIFA Advantage and Disadvantage indices), with at least 1/3 of the sample derived from areas of known deprivation. The sample has been selected to ensure representation across these variables, but it will not be fully representative of the population.

To ensure a whole-centre approach to the professional development, centres were required to send at least two staff members to each of the face-to-face professional development sessions. At least one of these staff members was required to be a university-trained Early Childhood Teacher. It was recommended that another be the centre director, but this need not be the case. A maximum of three staff members per centre could be accommodated in the professional development.
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
See above re: stratification variables. Centres were excluded if they were not located within the target regions or did not have data on the stratification variables.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As this study adopted a cluster randomised controlled trial design, participants (children and centres) were assigned to control or intervention groups randomly by cluster (centre). This randomisation did not occur until after: (a) recruitment of centres was complete; and (b) the initial baseline environment ratings were complete. As such, those involved in recruitment of centres were unaware, at the time of recruitment, to which group the centres would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation of centres (cluster) using a randomisation table created by computer software (i.e. computerised sequence generation). Stratification factors include centre type, baseline environmental rating, NQS rating and SEIFA decile.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Firstly changes in child outcomes will be measured in a multi-level model where a specific intervention-control comparison will be included. In applying power calculations, we need to consider that children are clustered in centres, and we need to adjust for the potentially greater similarity of children within a centre. Conservative power estimates, after adjusting for the clustered (nested) design, indicate that we can detect an effect size as low as 0.17 SD for child outcomes.

Given there are 45 treatment centres and 45 control centres. An conservative estimate of the children per centre is 13 children, giving a total sample size of 1170. The effect size mentioned above depended on:
1. The Type I error rate (alpha = .05)
2. The unit of comparison, i.e., children (N = 1170), or centre (N = 90): effect size for difference between centres = .597, effect size for difference between children in a multilevel model = .17, effect size for difference between children assumed independent = .16
3. For children, whether they are assumed to be independent observations or to be clustered within centres (see point 2 above)
4. Where children are assumed to be clustered within centres, how much of the variability is between centres and how much of the variability is between children within centres.

Subsequently we will compare 45 intervention and 45 control centres for environmental quality in order to estimate the effect on centre quality ratings.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/02/2016
Date of last participant enrolment
Anticipated
31/05/2016
Actual
31/05/2016
Date of last data collection
Anticipated
Actual
30/11/2016
Sample size
Target
1200
Accrual to date
Final
1260
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293340 0
Government body
Name [1] 293340 0
NSW Department of Education
Country [1] 293340 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Early Start, University of Wollongong
Northfields Avenue
Wollongong, NSW
2522
Country
Australia
Secondary sponsor category [1] 292159 0
None
Name [1] 292159 0
Address [1] 292159 0
Country [1] 292159 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294809 0
University of Wollongong Social Sciences HREC
Ethics committee address [1] 294809 0
Ethics committee country [1] 294809 0
Australia
Date submitted for ethics approval [1] 294809 0
04/08/2015
Approval date [1] 294809 0
08/09/2015
Ethics approval number [1] 294809 0
HE15/309

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

Contacts
Principal investigator
Name 64914 0
Prof Iram Siraj
Address 64914 0
Early Start, University of Wollongong
Northfields Avenue
Wollongong, NSW
2522
Country 64914 0
Australia
Phone 64914 0
+61 2 4221 5165
Fax 64914 0
Email 64914 0
[email protected]
Contact person for public queries
Name 64915 0
Steven Howard
Address 64915 0
School of Education, University of Wollongong
Northfields Avenue
Wollongong, NSW
2522
Country 64915 0
Australia
Phone 64915 0
+61 2 4221 5165
Fax 64915 0
Email 64915 0
[email protected]
Contact person for scientific queries
Name 64916 0
Steven Howard
Address 64916 0
School of Education, University of Wollongong
Northfields Avenue
Wollongong, NSW
2522
Country 64916 0
Australia
Phone 64916 0
+61 2 4221 5165
Fax 64916 0
Email 64916 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
EmbaseFostering Effective Early Learning (FEEL) through a professional development programme for early childhood educators to improve professional practice and child outcomes in the year before formal schooling: Study protocol for a cluster randomised controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1742-1
Dimensions AIImproving quality of teaching and child development: A randomised controlled trial of the leadership for learning intervention in preschools2023https://doi.org/10.3389/fpsyg.2022.1092284
N.B. These documents automatically identified may not have been verified by the study sponsor.