Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622001175763
Ethics application status
Approved
Date submitted
9/08/2022
Date registered
31/08/2022
Date last updated
31/08/2022
Date data sharing statement initially provided
31/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting Educators to Support Children with Maladaptive Behaviours within the Early Childhood Educational Context.
Scientific title
Supporting Educators to Support Children with Maladaptive Behaviours within the Early Childhood Educational Context using a novel professional learning package.
Secondary ID [1] 306915 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maladaptive behaviours 326020 0
Condition category
Condition code
Mental Health 323327 323327 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a professional learning (PL) package, coupled with in-residence mentoring to embed practices into the everyday practices of early childhood educators. The intervention will be delivered by an early childhood teacher/researcher with over 20 years of experience teaching early childhood education and 7 years of experience in research. The professional learning will consist of 7 monthly face-to-face sessions of up to 5 hours each duration. The in-residence mentoring will occur in between PL sessions, for approximately 3 to 4 hours each. It is expected that the intervention will begin in late September 2022 and finish in April 2023. The PL will be facilitated with early childhood educators - the PL will be facilitated at their head office and the in-residence mentoring will be facilitated in their own early learning centres.
The training modules will comprise of a PowerPoint presentation to share content, interactive activities and video clips to support participants learning. Goal setting and reflective practice will be key components throughout the training modules and in-residence mentoring. Participants will have asynchronous access to a Padlet for additional resources related to the module content. It is expected that each module will be presented twice in a one-week period to enable all participating educators to attend (relieving multiple educators from face-to-face teaching is currently limited due to workforce shortages). It is expected that each session will comprise of a maximum 6 participants and 1 facilitator. Attendance will be recorded.
The professional learning has been designed specifically for this study.
The professional learning will consist of the following topics:
*Children's brains, behaviour and learning
Key learning focuses on understanding brain development, with links to behaviour, learning and development made. participants will understand factors that shape brain development, as well as the sensitive and critical periods of influence. Educators will engage with content focused on the importance of quality environments and interactions for brain development.
*The significance of relationships
The key learning focus of this topic is why relationships matter, delving into attachment approaches and theories in educational contexts (e.g.: Circle of Security, Bowlby, Ainsworth), as well as indicators of poor attachment. Participants will be guided on relationships across various contexts - family, community, and place, as well as effective strategies for developing positive and responsive relationships with young children. This topic will address factors that impact attachment, as well as developing environments/relationships for safety, security and belonging.
*Ways to understand children's behaviour
Participants will look at contemporary developmental and ecological theories, as well as develop an understanding of risk and resilience. The Codes of Behaviour (Rappaport & Minahan, 2012) will be introduced, as will the Neuro-sequential Modle of Therapeutics (Dr Bruce Perry) and the work of Dr Daniel Seigel around the Windows of Tolerance, to develop a framework of understanding behaviour in young children. Participants will explore attitudes and beliefs about behaviour in educational contexts, and how to create common/shared language and purpose within teams and with families.
*Children's self-regulation
participants will develop a greater understanding of children's self-regulation and its developmental significance. This topic will offer approaches to support children's emotional regulation, thoughts and behaviours, as well as interventions and learning supports that can be implemented in an early years context. Conflict resolution processes will be a key aspect, as well as how to approach the assessment of children's self-regulation.
*Social and emotional development
This topic focuses on meeting the emotional needs of children in an educational context. Participants will gain an increased understanding of social and emotional development in the early years, with links to children's well-being. Educators will be introduced to personalised attunement, tailoring interactions to meet the emotional needs of individual children, as well as showing and developing empathy and emotional awareness.
*Supporting children's behaviour
Practical ideas on creating responsive and supportive learning environments will be the focus of this topic. participants will learn pre-emptive strategies to reduce the occurrence of challenging behaviours, differentiated pedagogy, language use, the need for daily routines, schedules, child's choice and intentional transitions, as well as tools and approaches to discover each child's individual needs.
*Trauma and trauma-informed practice
This topic will enable educators to recognise children's trauma histories and understand children's unique triggers and supports. It will address how to assess the environment, harm and re-traumatisation, with an emphasis on strength building and skill acquisition and building resilience.
*Maladaptive behaviours and dysregulation
This topic will delve further into the Windows of Tolerance, Neuro-Sequential Model of Therapeutics, with participants understanding the signs and signals of a changing state of arousal (hypo v's Hyperarousal). Key practical strategies and practices for supporting children will be explored.
*Staff wellbeing
The psychological and physiological components of well-being will be shared, as will the links between educator well-being and children's behaviour. We will delve into team well-being, and explore creating supportive and responsive work environments. Building educator resilience will be part of this topic, as well as supporting colleagues' well-being.
*Working with families and communities to support children's behaviour
This topic will look at how to build positive and responsive relationships with families, and how to approach collaboration and support regarding children's behaviour. Supports for the Home Learning Environment will be explored, with practices and activities being shared.
*Programming and planning
Participants will explore tools for planning, as well as assessing for challenging situations. Educators will understand how to develop individual learning and behaviour support plans that support practice to respond to children's behavioural and emotional regulation. Sustainable practices will be explored to ensure the knowledge and understanding gained in the intervention can continue to be implemented post-intervention.

The mentoring sessions will be guided by the goals set by individual participants or service teams at the conclusion of each module. These goals will become the focus for the 3 hour mentoring session. The mentoring session will be a time where the mentor and mentees will work together to strengthen knowledge gained from the professional learning, putting this into practice during a regular work day. Guidance and advice will be provided as necessary, as well as fostering a reflective learning environment. The 3 to 4 hour mentoring session will take place on one day approximately 2 weeks after the professional learning session. Post mentoring session, the mentor will write field notes detailing the session, including which educators engaged in the session and the focus of the time spent together. Facilitators and challenges will be noted.
Intervention code [1] 323363 0
Behaviour
Comparator / control treatment
The control arm of the intervention will be waitlisted and will continue with their early childhood education practice as usual. They will receive the intervention material following the completion of the study. While these participants will not receive any professional development until the completion of post-intervention measures, they may engage in other professional development throughout the intervention period as deemed appropriate by their parent organisation. Participants in the control arm will be asked to record any professional learning engaged with during the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 332060 0
Change in children's self-regulation assessed using the Preschool Situational Assessment Toolkit (PRSIST) assessment.
Timepoint [1] 332060 0
Baseline, mid-intervention (18 weeks post-intervention commencement) and post-intervention (2 weeks post-intervention completion).
Secondary outcome [1] 412028 0
Changes in quality of early learning environment as measured by the Sustained Shared Thinking & Emotional Wellbeing scale (SSTEW).
Timepoint [1] 412028 0
Baseline and post-intervention (2 weeks post-intervention completion).
Secondary outcome [2] 412747 0
Change in the quality of the educator-child relationship as measured by the Student Teacher Relationship Scale (STRS).
Timepoint [2] 412747 0
Baseline and post-intervention (2 weeks post-intervention completion).

Eligibility
Key inclusion criteria
Children who are enrolled in early education centres in 2022 and 2023, are at least three years old at baseline data collection and are enrolled a minimum of two days per week.

Early childhood educators who work face to face with children aged three to five years.

Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any child with a formal diagnosis of autism spectrum disorder (ASD).

There are no specific exclusions pertaining to early childhood educators.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
The early childhood services will be paired based on the baseline SSTEW Scores and then randomised by simple randomisation procedures. Early childhood centres will be randomised using a computer-based random number-producing algorithm to either the intervention group or the wait-list control group (Suresh, 2011).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Waitlisted. The control group will not receive any intervention during the intervention period. They will receive the professional learning package only after the post-intervention data has been collected.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mean level variances in children's self-regulatory data will be examined through an analysis of variance (ANOVA).

The Wilcoxon matched pairs test (due to small n) will be used to explore the mean level differences between the control and intervention groups with respect to (a) room-level shifts in practice as well as (b) shifts in teacher-child relationships.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
31/05/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 38152 0
2147 - Kings Langley
Recruitment postcode(s) [2] 38153 0
2148 - Kings Park
Recruitment postcode(s) [3] 38154 0
2148 - Prospect
Recruitment postcode(s) [4] 38155 0
2766 - Rooty Hill

Funding & Sponsors
Funding source category [1] 311224 0
University
Name [1] 311224 0
University of Wollongong
Country [1] 311224 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave
Keiraville
2522
NSW
Country
Australia
Secondary sponsor category [1] 312594 0
None
Name [1] 312594 0
Address [1] 312594 0
Country [1] 312594 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310751 0
University of Wollongong Human Ethics Committee
Ethics committee address [1] 310751 0
Ethics committee country [1] 310751 0
Australia
Date submitted for ethics approval [1] 310751 0
29/04/2022
Approval date [1] 310751 0
15/06/2022
Ethics approval number [1] 310751 0
2022/137

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

Contacts
Principal investigator
Name 118738 0
A/Prof Cathrine Neilsen-Hewett
Address 118738 0
University of Wollongong
Building 21:110B
Northfields Ave
Keiraville
NSW
2522
Country 118738 0
Australia
Phone 118738 0
+61 0242215543
Fax 118738 0
Email 118738 0
[email protected]
Contact person for public queries
Name 118739 0
Fay Gowers
Address 118739 0
University of Wollongong
Building 21:110
Northfields Ave
Keiraville
NSW
2522
Country 118739 0
Australia
Phone 118739 0
+61 0242215789
Fax 118739 0
Email 118739 0
[email protected]
Contact person for scientific queries
Name 118740 0
Fay Gowers
Address 118740 0
University of Wollongong
Building 21:110
Northfields Ave
Keiraville
NSW
2522
Country 118740 0
Australia
Phone 118740 0
+61 0242215789
Fax 118740 0
Email 118740 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.