Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001405101
Ethics application status
Approved
Date submitted
20/08/2019
Date registered
14/10/2019
Date last updated
14/10/2019
Date data sharing statement initially provided
14/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of the AllPlay Learn professional development course for early childhood educators and primary school teachers: a pilot randomised controlled trial
Scientific title
Feasibility of the AllPlay Learn professional development course for early childhood educators and primary school teachers: a pilot randomised controlled trial
Secondary ID [1] 298952 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention-deficit/hyperactivity disorder 313935 0
Anxiety 313936 0
Autism 313937 0
Communication and language disorders 313938 0
Developmental delay 313939 0
Physical disability 313940 0
Condition category
Condition code
Mental Health 312342 312342 0 0
Autistic spectrum disorders
Mental Health 312343 312343 0 0
Anxiety
Mental Health 312344 312344 0 0
Learning disabilities
Mental Health 312345 312345 0 0
Studies of normal psychology, cognitive function and behaviour
Musculoskeletal 312582 312582 0 0
Other muscular and skeletal disorders
Neurological 312583 312583 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two intervention groups: 1) intervention group A: an online professional learning course (“professional learning group”); 2) intervention group B: an online web resource (“website group”).

AllPlay Learn professional learning course:

AllPlay Learn Inclusive Foundations for Children with Disabilities courses (www.learn.allplaylearn.org.au) will be available to Victorian long day care centres, kindergartens, and government primary and secondary schools from August 2019. The courses focus on content knowledge about disabilities and provide strengths- and evidence-based strategies that are practical and simple for educators and teachers to implement. Teachers can choose from different lessons within a course to suit their learning needs and interests. Completion of each course takes approximately 4 to 6 hours.

AllPlay Learn website:
AllPlay Learn’s website (www.allplaylearn.org.au) will be available from August 2019. The website provides information and resources that draw on strengths- and evidence-based research to help create inclusive educational environments for children and young people with disabilities and developmental challenges. The website has targeted information and resources for:
• Primary and secondary schools
• Early childhood educators and professionals
• Primary and secondary school teachers
• Children and young people with disabilities
• Guardians, carers and parents

Information and resources are easy to download and print for use across homes, long day care, kindergarten and schools.

Intervention procedure:

Teachers/educators in the professional learning group will be asked to complete the professional learning course during the first three weeks of Term 4 (October 2019). Similarly, teachers/educators in the website group will be asked to use the website within the same period.

Over the six weeks directly following the study period, teachers/educators allocated to the professional learning group or website groups will be asked to implement and document their use of the AllPlay Learn content knowledge, strategies and resources in planning, teaching and assessment.

All teachers/educators will be provided with a journal. All planning, assessment and implementation documents pertaining to the focus child will be placed by the teachers/educators into the journal.

For group A there are a core set of 5 modules that participants must complete as part of the professional learning, and they can choose 2 out of 5 elective modules. They must complete 7 modules to complete the professional learning, but can take up to 10 modules in total.

Participants must complete the course over the first three week intervention phase of the trial.

The 5 early childhood core modules are focused on: Basics of inclusion, questions that promote inclusion, the ABCs of behaviour, emotions, and educator wellbeing.
ECE participants can choose 2-5 elective modules: Anxiety, autism, communication disorders, developmental delay, physical disability and cerebral palsy.

The 5 primary school core modules are focused on: Basics of inclusion, questions that promote inclusion, the ABCs of behaviour, peer mediation, and teacher wellbeing.
Primary school participants can choose 2-5 elective modules: Anxiety, Attention-deficit/hyperactivity disorder, autism, behaviour, physical disability and cerebral palsy.

The 6 secondary school core modules are focused on: Basics of inclusion, three inclusive questions to consider, the ABCs of behaviour, Emotion and behaviour regulation, Post-school transitions, and teacher wellbeing.
Secondary school participants can choose 2-3 elective modules: Anxiety, Attention-deficit/hyperactivity disorder, and autism.

Each training course will take between 4-6 hours to complete all of the required modules.

Statistics regarding access and usage of the professional learning courses will be available from the AllPlay Learn system (e.g. amount of time teachers spend on each course or website topic, which modules they complete etc).

For group B the information and resources provided are readily available at: https://allplaylearn.org.au/

Participants in group B are not given guidance on how often to access the website, this is at their own discretion over the three week intervention period.

Participants in group B will be given a website log in so that we can monitor the website metrics.
Intervention code [1] 315225 0
Behaviour
Comparator / control treatment
Teachers/educators in the waitlist control group will not access the professional learning courses or website during the trial and will be asked to continue planning, teaching and assessing as normal. They will however be offered these online resources after the intervention and implementation period of the trial has finished (December 2019).
Control group
Active

Outcomes
Primary outcome [1] 320972 0
Feasibility and acceptability are assessed via qualitative interviews after conducting a randomised control trial that evaluates early childhood educators’ and primary school teachers’ use of the AllPlay Learn website and professional learning course (composite primary outcome).
Qualitative interviews will be audio recorded and one-on-one with families and teachers/educators separately. The interviews will be semi-structured and will be for up to 30 minutes.
Timepoint [1] 320972 0
Nine weeks post randomisation
Secondary outcome [1] 373572 0
Early childhood educators’ and primary school teachers’ confidence in supporting children with disabilities or developmental challenges in their classrooms (self report on study generated scale using a 4-point likert scale).


Timepoint [1] 373572 0
Baseline, start of intervention, end of intervention, and nine weeks post randomisation
Secondary outcome [2] 373573 0
Early childhood educators’ and primary school teachers’ competence in supporting children with disabilities or developmental challenges in their classrooms (self report on study generated scale using a 4-point likert scale).
Timepoint [2] 373573 0
Baseline, start of intervention, end of intervention, and nine weeks post randomisation
Secondary outcome [3] 373574 0
Child mental health as recorded using the Strengths and Difficulties Questionnaire (teacher/educator report)
Timepoint [3] 373574 0
Baseline and 9 weeks post randomisation
Secondary outcome [4] 373595 0
Teacher/parent communication and relationship (composite secondary outcome; both teacher/educator and parent report via qualitative semi-structured interviews).
The interviews will be one-on-one with the teacher/educator and interviewer, or family member and interviewer. They will take 30 - 45 minutes and be audio recorded.
Timepoint [4] 373595 0
9 weeks post randomisation
Secondary outcome [5] 375133 0
Child mental health as recorded using the Strengths and Difficulties Questionnaire (parent report)
Timepoint [5] 375133 0
Baseline and 9 weeks post randomisation

Eligibility
Key inclusion criteria
a) The teacher/educator reports having one or more children/students in their class with a developmental or physical disability. This must include any of these six disabilities:
Anxiety
Autism
Attention-deficit/hyperactivity disorder
Communication and language disorders
Developmental delay
Physical disability

b) Teachers and educators have between 1 – 5 years teaching experience
c) Primary school teachers work in grades 1 – 4 (approx. age of children will be between 6 – 10 years).
d) Early childhood educators work with children 3 years and older.
e) The teacher/educator and the family must both consent to joining the study in order for either to take part.
f) Families must be parent of the child who has been chosen by the teacher or educator that fits the criteria (the child has one of the six disabilities).
Minimum age
17 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule will be pre- generated via a computer generated random sequence by a statistician independent from the research project and loaded into the REDCap online platform. Schools and early childcare centres will be randomised by a researcher independent of the project
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
This is a small pilot trial to determine the feasibility and acceptability of the AllPlay Learn professional learning courses in early childhood education settings and primary schools.. For the current pilot, we require up to 30 early childhood educators (10 intervention, 10 website group, 10 waitlist control), 30 primary school teachers (10 intervention, 10 website group, 10 control group), and 60 families in total (20 intervention, 20 website group, 20 control group).

Descriptive statistics will be used to summarize the acceptability and feasibility of the intervention. The mean difference in secondary outcomes between the control and intervention groups will be examined using logistic and linear regression. Given the proof-of principle nature of this study, it will focus on effect sizes (Cohen’s d) rather than statistical significance testing.

Thematic analysis of reflection questions for the professional learning group will be used. Inductive analysis of the teacher critical interview transcripts will determine teacher articulations of their planning and implementation practices after the intervention (Cresswell, 2013).

All coding and analysis will be subject to inter-observer checks.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/10/2019
Actual
Date of last participant enrolment
Anticipated
28/10/2019
Actual
Date of last data collection
Anticipated
20/12/2019
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303493 0
Government body
Name [1] 303493 0
Victorian Department of Education and Training
Country [1] 303493 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy 3125, Victoria,
Country
Australia
Secondary sponsor category [1] 303551 0
None
Name [1] 303551 0
Address [1] 303551 0
Country [1] 303551 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304017 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 304017 0
Deakin Research Integrity
Deakin University
221 Burwood Hwy
Burwood, VIC 3125
Ethics committee country [1] 304017 0
Australia
Date submitted for ethics approval [1] 304017 0
02/08/2019
Approval date [1] 304017 0
20/08/2019
Ethics approval number [1] 304017 0
2019-302

Summary
Brief summary
This pilot study aims to assess the feasibility and acceptability of conducting a pilot randomised control trial to evaluate using AllPlay Learn website and/or professional learning courses as a ‘professional learning intervention’ among educators in early childhood education and care settings (i.e. long day care centres and/or kindergartens) and teachers in primary school classrooms. We will use a feasibility and acceptability evaluation and will measure the effects of the intervention on educators’ and teachers’ self-reported competence and confidence, and children’s emotional regulation, conduct, attention, peer relations and pro-social skills (reported by educators, teachers and parents).
Trial website
www.allplaylearn.org.au

This is the website that will be used by participants for the study. They will use either the website only or the website and the professional learning course.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95578 0
Prof Nicole Rinehart
Address 95578 0
Deakin Child Study Centre
School of Psychology
Deakin University, Melbourne Burwood Campus
221 Burwood Hwy VIC 3125
Country 95578 0
Australia
Phone 95578 0
+61 3 92445469
Fax 95578 0
Email 95578 0
nicole.rinehart@deakin.edu.au
Contact person for public queries
Name 95579 0
Dr Ana Mantilla
Address 95579 0
Deakin Child Study Centre
School of Psychology
Deakin University, Melbourne Burwood Campus
221 Burwood Hwy VIC 3125
Country 95579 0
Australia
Phone 95579 0
+61 3 92445204
Fax 95579 0
Email 95579 0
ana.mantilla@deakin.edu.au
Contact person for scientific queries
Name 95580 0
Dr Ana Mantilla
Address 95580 0
Deakin Child Study Centre
School of Psychology
Deakin University, Melbourne Burwood Campus
221 Burwood Hwy VIC 3125
Country 95580 0
Australia
Phone 95580 0
+61 3 92445204
Fax 95580 0
Email 95580 0
ana.mantilla@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregated results will be reported.


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.