Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001271897
Ethics application status
Approved
Date submitted
3/05/2021
Date registered
20/09/2021
Date last updated
2/09/2022
Date data sharing statement initially provided
20/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the impact of educator training on educators and children attending early childhood education centres in Western Sydney
Scientific title
The effect of childhood educator training delivered by speech-language pathologists on the skills of educators and communication of children attending early childhood education centres in Western Sydney
Secondary ID [1] 303586 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Language developmental delay 322168 0
Condition category
Condition code
Public Health 319028 319028 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an approved modified version of the Learning Language and Loving It Online program [Trademark] developed by the Hanen Centre [Registered Trademark].
This online educator training program goes for 8 weeks. It involves educator attendance at five online workshop sessions and three 1-on-1 videoconference coaching sessions. All aspects of the training will be delivered virtually due to the impacts of the pandemic.
In Stage 1 (Term 3 2021), one group of 12 educators (Group A) will receive the 8 week training program. In Stage 2 (Term 4 2021), Group A will receive no further training. Group A will act as a follow-up group.

WORKSHOPS (2.5 hours each):
Educator workshops will be delivered by 2 speech pathologists who are formally trained in the program and currently employed by Western Sydney Local Health District. All workshop sessions will be conducted online via Zoom in a group format (10-14 educators per group). Mode includes powerpoint presentation, breakout rooms, discussions and written comments in the chat function of Zoom.
Attendance at workshops will be assessed using an attendance list at each session for participants of the current research trial.
Information materials: Hanen Learning Language and Loving it [Trademark] guidebook will be available to all educators throughout training

1-ON-1 COACHING SESSIONS (45 minutes each):
These will take place via videoconference between the educator and one speech pathologist trainer. They will view and discuss a videoed interaction between an educator and children at their centre

Training schedule:
Week 1: Workshop 1- Take a Closer Look at Communication
*Topics covered: Communication means interaction and information, Roles teachers play during interactions, Children’s conversational styles, Stages of language development
Week 2: Workshop 2- Follow the Child’s Lead
*Topics covered: Observe wait and listen so the child can lead, Be face to face, Follow the child’s lead- comment, imitate, interpret, join in and play, Give a reason to communicate and wait
Week 3: First 1-on-1 coaching session
Week 4: Workshop 3- Taking Turns Together
*Topics covered: Supporting turns in conversations, Laying the foundation for conversations with discoverers and communicators, Make social routines part of your day, Using comments and questions to cue turns
Week 5: Workshop 4- Encourage Interaction in Group Situations
*Topics covered: Interact with every child in the group- you can if you SSCAN, Small groups are best, Set up an appropriate activity, Carefully observe each child’s level of participation and interaction, Adapt your response to each child’s needs
Week 6: Second 1-on-1 coaching session
Week 7: Workshop 5- Provide Information that Promotes Language Learning
*Topics covered: Make your language easy to understand, Add new words, Expand what the child says
Week 8: Third 1-on-1 coaching session

Study Duration: 24 weeks, comprised of:
-2 weeks data collection before training stage 1
-8 week training (stage 1)
-4 week gap between training stages
-8 week training (stage 2)
-2 weeks data collection following training stage 2

Method of allocation: Pseudo-cluster randomisation; we will use the random number generator at https://www.random.org/integers/ to allocate centres. Therefore, pseudo-cluster randomisation will be implemented, as centres who are available in one time period only will not be randomised for pragmatic reasons. Randomisation will occur at the cluster or centre level to avoid cross-contamination effects between trained and untrained educators. This will occur after educators and children have been recruited in to the current study. This pseudo- randomisation is required for the current, pragmatic study.
Intervention code [1] 319935 0
Behaviour
Comparator / control treatment
In Stage 1 (Term 3 2021), one group of 12 educators (Group B) will receive no training for 8 weeks. Group B will therefore act as a no-treatment control group.
In Stage 2 (Term 4 2021), Group B will receive the 8 week training program.
Control group
Active

Outcomes
Primary outcome [1] 326933 0
Child primary outcome measure: Change in Mean Length of Utterance (MLU) of participating children across Stage 1 of educator training

How MLU will be measured: MLU will be calculated based on children's language demonstrated in 15 minute play-based language samples with an educator at their early childhood education centre. Mean length of utterance is a well-established measure of child language first described by Brown (1973). The calculation of mean length of utterance is based on the average number of morphemes produced per child utterance. It is an appropriate measure of language for young children (Ezeizabarrena & Fernandez, 2018).
Timepoint [1] 326933 0
Please note that Time 1 refers to the recruitment and screening phase
Mean Length of Utterance (MLU) will be measured during 15 minute play-based language samples with an educator at their early childhood education centre at these time points:
*Time 2: within 2 weeks before the commencement of Stage 1 training
*Time 3: within 2 weeks after the conclusion of Stage 1

Change in MLU will be the difference score across Stage 1 (Time 3- Time 2).
Primary outcome [2] 326934 0
Educator primary outcome measure: Change in a composite score which measures overall use of trained interaction skills by educators in interactions with a child across Stage 1 of educator training.

How composite score will be calculated: Educator interaction skills will be measured during 15 minute language interactions with a child in their care. Eight target interaction strategies were defined by speech pathologists in WSLHD, with reference to the Teacher Interaction and Language Rating Scale (TILRS; Girolametto, Weitzman, & Greenberg, 2000) and the Conversational Responsiveness Assessment and Fidelity Tool (CRAFT; Friel, Wiggins, & Justice, 2007). Target interaction skills include three Child-oriented strategies, two Interaction-promoting strategies and three Language-modeling strategies. Child-oriented strategies include: (1) Encourages child to initiate by observing, waiting expectantly and listening, (2) Responds to the child’s initiation with animation and specific language, and (3) Adjusts their position so that they are face to face with the child. Interaction-promoting strategies include: (4) Uses a variety of questions to stimulate conversations, and (5) Encourages turn taking. Language-modeling strategies include: (6) Uses a variety of vocabulary, (7) Expands the child’s utterances by recasting and adding ideas, and (8) Extends the child’s utterances by giving information about the topic. Each of these eight strategies will be coded as ‘absent’ (0) or ‘present’ (1) for each 30 second segment of the 15-minute interaction. An average will be taken for each strategy across all segments of the video. Then, all average scores will be summed to create a composite score of use of interaction strategies by educators.
Timepoint [2] 326934 0
Please note that Time 1 refers to the recruitment and screening phase
The composite score which measures overall use of trained interaction skills by educators will be measured at these time points:
*Time 2: within 2 weeks before the commencement of Stage 1 training
*Time 3: within 2 weeks after the conclusion of Stage 1

Change in this composite score will be the difference score across Stage 1 (Time 3- Time 2).
Secondary outcome [1] 393173 0
Child secondary outcome measure: Change in Mean Length of Utterance (MLU) of participating children across Stage 2 of educator training.

How MLU will be measured: MLU will be calculated based on children's language demonstrated in 15 minute play-based language samples with an educator at their early childhood education centre. Mean length of utterance is a well-established measure of child language first described by Brown (1973). The calculation of mean length of utterance is based on the average number of morphemes produced per child utterance. It is an appropriate measure of language for young children (Ezeizabarrena & Fernandez, 2018).
Timepoint [1] 393173 0
Please note that Time 1 refers to the recruitment and screening phase
Mean Length of Utterance (MLU) will be measured during 15 minute play-based language samples with an educator at their early childhood education centre at these time points:
*Time 4: within 2 weeks prior to commencement of Stage 2 training
*Time 5: within 2 weeks after the conclusion of Stage 2 training

Change in MLU will be the difference score across Stage 2 (Time 5- Time 4).
Secondary outcome [2] 393175 0
Educator secondary outcome measure: Change in a composite score which measures overall use of trained interaction skills by educators in interactions with a child across Stage 2 of educator training.

How composite score will be calculated: Educator interaction skills will be measured during 15 minute language interactions with a child in their care. Eight target interaction strategies were defined by speech pathologists in WSLHD, with reference to the Teacher Interaction and Language Rating Scale (TILRS; Girolametto, Weitzman, & Greenberg, 2000) and the Conversational Responsiveness Assessment and Fidelity Tool (CRAFT; Friel, Wiggins, & Justice, 2007). Target interaction skills include three Child-oriented strategies, two Interaction-promoting strategies and three Language-modeling strategies. Child-oriented strategies include: (1) Encourages child to initiate by observing, waiting expectantly and listening, (2) Responds to the child’s initiation with animation and specific language, and (3) Adjusts their position so that they are face to face with the child. Interaction-promoting strategies include: (4) Uses a variety of questions to stimulate conversations, and (5) Encourages turn taking. Language-modeling strategies include: (6) Uses a variety of vocabulary, (7) Expands the child’s utterances by recasting and adding ideas, and (8) Extends the child’s utterances by giving information about the topic. Each of these eight strategies will be coded as ‘absent’ (0) or ‘present’ (1) for each 30 second segment of the 15-minute interaction. An average will be taken for each strategy across all segments of the video. Then, all average scores will be summed to create a composite score of use of interaction strategies by educators.
Timepoint [2] 393175 0
Please note that Time 1 refers to the recruitment and screening phase
The composite score which measures overall use of trained interaction skills by educators will be measured at these time points:
*Time 4: within 2 weeks prior to commencement of Stage 2 training
*Time 5: within 2 weeks after the conclusion of Stage 2 training

Change in this composite score will be the difference score across Stage 2 (Time 5- Time 4).

Eligibility
Key inclusion criteria
This study will include educator (adult) and child participants. Inclusion criteria for both are listed below
- Educators: Only educators enrolled to participate in the Training will be eligible for the current study. Inclusion criteria for educators will include consent to participate in all stages of the study and anticipated completion of the Training program. No limitations on educator participation will be made based on prior training or level of education.
- Children: Inclusion criteria for child participants are: (1) aged 24-42 months and attend the consenting educator’s early childhood education centre at least one day per week, (2) no parental concerns about speech and/or language development, (3) no concerns identified based on the child’s performance on the Communication section of the Ages and Stages Questionnaire (ASQ; Squires, Bricker & Twombly, 2009) completed with a parent in an initial phone call, and (4) no concerns identified based on the Preschool Language Scales Screener (PLS; Zimmerman, Steiner, & Pond, 2011) completed via videoconference by a speech pathologist at the child’s centre. Eligibility will be confirmed after consent has been received from interested parents and the child’s screening has been completed.
Minimum age
24 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centres participating in the Training will indicate availability for either or both of the training periods. We will use the random number generator at https://www.random.org/integers/ to allocate centres who indicate availability for both stages. Therefore, pseudo-cluster randomisation will be implemented, as centres who are available in one time period only will not be randomised for pragmatic reasons. Randomisation will occur at the cluster or centre level to avoid cross-contamination effects between trained and untrained educators within one centre. This will occur after educators and children have been recruited in to the current study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Methods of randomisation and allocation: Randomisation will occur at the cluster (centre) level to avoid cross-contamination effects between trained and untrained educators within one centre. This will occur after educators and children have been recruited in to the current study. Participants will be randomised into either Group A or Group B.

Both groups receive the same intervention at two different points in time; Group A receives the training in Stage 1 (Term 3 2021) and Group B receives the training in Stage 2 (Term 4 2021). Analysis will be conducted independently for each intervention Stage. In Stage 1, the intervention group (Group A) will be compared to the control non-intervention group (Group B). In Stage 2, the intervention group (Group B) will be compared to the non-intervention follow up group (Group A).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE ESTIMATION, JUSTIFICATION, AND CALCULATION
The sample size will be 24 Child-Educator dyads. A target of 12 dyads will be in Group A and 12 will be in Group B. Sample size was calculated based on the assumption of paired sample analysis with two comparison groups (Cohort 1 and Cohort 2) with alpha set at 0.05 and a confidence interval of 90% (Machin, Campbell, Tan & Tan, 2018). Effect size for the primary outcome measure, children’s Mean Length of Utterance, was 4.96 in a recent, similar investigation (Piasta et al., 2012). This sample size is also selected as a pragmatic threshold due to the likely enrolment of 24-28 educators per training period with an approximate 50% recruitment rate. A sample size larger than 24 dyads is not feasible for the context of the current study. This calculation also allows for dropout of 10% which is consistent with previous similar investigations. This sample size is also comparable to other similar studies in early childhood education (cf McDonald et al., 2015).

STATISTICAL METHODS TO BE UNDERTAKEN
All questionnaire data will be collected via Microsoft Teams and exported in raw format for processing in R or SPSS. Demographic information (including age, languages spoken, language proficiency, educator level of education, educator years of experience, and child communication measures [ASQ and PLS]) will be described for all dyad participants. Two multiple linear regression analyses will be conducted to address the primary aim (Stage 1 contrast) and our secondary aim (Stage 2 contrast). The outcome (dependent variable) for both analyses will be children’s mean length of utterance Difference Score across each Stage. Independent variables will be Group allocation (A or B) and cluster (ECEC). This analysis plan will allow for the primary investigation to be conducted on data collected in Stage 1. This primary analysis will investigate the impact of group allocation (Training [Group A]; Control [Group B]) and cluster (Educator Centre) on children’s language output (Mean Length of Utterance). The secondary investigation will be conducted on data collected in Stage 2. This secondary analysis will investigate the impact of group allocation (No-training follow-up [Group A]; Training [Group B]) and cluster (Educator centre) on children’s language output.
Intention-to-treat analysis will be completed in the event of educator drop-out from the training. If appropriate, per-protocol analysis will be completed to investigate the primary and secondary outcomes in the event of high fidelity of the educator training.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
28/05/2021
Date of last participant enrolment
Anticipated
Actual
16/07/2021
Date of last data collection
Anticipated
31/12/2021
Actual
17/12/2021
Sample size
Target
48
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 33507 0
2144 - Auburn
Recruitment postcode(s) [2] 33508 0
2141 - Berala
Recruitment postcode(s) [3] 33509 0
2162 - Chester Hill
Recruitment postcode(s) [4] 33510 0
2145 - Girraween
Recruitment postcode(s) [5] 33511 0
2142 - Granville
Recruitment postcode(s) [6] 33512 0
2145 - Greystanes
Recruitment postcode(s) [7] 33513 0
2161 - Guildford
Recruitment postcode(s) [8] 33514 0
2161 - Guildford West
Recruitment postcode(s) [9] 33515 0
2142 - Holroyd
Recruitment postcode(s) [10] 33516 0
2141 - Lidcombe
Recruitment postcode(s) [11] 33517 0
2145 - Mays Hill
Recruitment postcode(s) [12] 33518 0
2160 - Merrylands
Recruitment postcode(s) [13] 33519 0
2160 - Merrylands West
Recruitment postcode(s) [14] 33520 0
2145 - Pemulwuy
Recruitment postcode(s) [15] 33521 0
2145 - Pendle Hill
Recruitment postcode(s) [16] 33522 0
2143 - Regents Park
Recruitment postcode(s) [17] 33523 0
2164 - Smithfield
Recruitment postcode(s) [18] 33524 0
2142 - South Granville
Recruitment postcode(s) [19] 33525 0
2145 - South Wentworthville
Recruitment postcode(s) [20] 33526 0
2146 - Toongabbie
Recruitment postcode(s) [21] 33527 0
2145 - Wentworthville
Recruitment postcode(s) [22] 33528 0
2145 - Westmead
Recruitment postcode(s) [23] 33529 0
2164 - Woodpark
Recruitment postcode(s) [24] 33530 0
2161 - Yennora

Funding & Sponsors
Funding source category [1] 308396 0
Government body
Name [1] 308396 0
Western Sydney Local Health District
Country [1] 308396 0
Australia
Funding source category [2] 309528 0
University
Name [2] 309528 0
The University of Sydney
Country [2] 309528 0
Australia
Funding source category [3] 309529 0
Government body
Name [3] 309529 0
NSW Ministry of Health Paediatric Innovation Funding Scheme
Country [3] 309529 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Institute Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 309226 0
None
Name [1] 309226 0
Address [1] 309226 0
Country [1] 309226 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307496 0
Sydney Children's Hospital Network HREC
Ethics committee address [1] 307496 0
Ethics committee country [1] 307496 0
Australia
Date submitted for ethics approval [1] 307496 0
01/03/2021
Approval date [1] 307496 0
11/05/2021
Ethics approval number [1] 307496 0
2020/ETH03162

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

Contacts
Principal investigator
Name 107442 0
Ms Alison Britton
Address 107442 0
Merrylands Community Health Centre
14 Memorial Ave, Merrylands NSW 2160
Country 107442 0
Australia
Phone 107442 0
+61 409469902
Fax 107442 0
Email 107442 0
[email protected]
Contact person for public queries
Name 107443 0
Alison Britton
Address 107443 0
Merrylands Community Health Centre
14 Memorial Ave, Merrylands NSW 2160
Country 107443 0
Australia
Phone 107443 0
+61 409469902
Fax 107443 0
Email 107443 0
[email protected]
Contact person for scientific queries
Name 107444 0
Sarah Masso
Address 107444 0
Speech Pathology
The University of Sydney
Camperdown
NSW 2006
Australia
Country 107444 0
Australia
Phone 107444 0
+612 9351 9881
Fax 107444 0
Email 107444 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
There is no intention to share the individual participant data publically due to the small geographical area of the study and the potential risk of identification (even after de-identification) if these data are shared publicly.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11415Study protocol    381096-(Uploaded-26-08-2021-10-29-59)-Study-related document.pdf
11416Statistical analysis plan    The statistical analysis plan is detailed within S... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.