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
ACTRN12622000146796
Ethics application status
Approved
Date submitted
26/11/2021
Date registered
28/01/2022
Date last updated
28/01/2022
Date data sharing statement initially provided
28/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Getting it right from the start (GIRFTS): Effect of an early years’ school intervention on student oral language and reading outcomes.
Scientific title
Effect of a response to intervention (RTI) approach on student oral language and reading outcomes in Grade 1 primary school students.
Secondary ID [1] 305867 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GIRFTS
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Poor oral language and reading 324417 0
Condition category
Condition code
Public Health 321911 321911 0 0
Health promotion/education
Mental Health 322442 322442 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 months (repeated) of a response to intervention (RTI) approach to improve oral language and reading for Grade 1 primary school students. The RTI approach involves Tiers 1 and 2.

**Tier 1**
Tier 1 comprises of an evidence-based approach to oral language/reading instruction applied to all Foundation and Grade 1 students in the classroom for 12 months. Grade 1 teachers undergo 6 weeks of professional learning for these strategies (6 professional learning sessions, ~1 hour each). Teachers learn the evidence-base for oral language and reading instruction by completing the Science of Language and Reading short course (run by La Trobe University, developed by A/Prof Pamela Snow and A/Prof Tanya Sherry).

Tier 1 teaching strategies will be embedding into regular classroom teaching of Grade 1 students for 12 months, rather than being administered according to a dosing and frequency schedule. This is because these practices are universal and can be incorporated onto the core instruction of all students in the classroom and the planning of lessons. For example, a strategy can be 'encourage all students to answer questions in full sentences' - this can be implemented throughout classroom teaching.

With the support from the ISP, teachers will plan small very short-term goals to incorporate these practices into their teaching. These rapid cycles of review can be as short as 1 week. This helps teachers to gradually integrate their learnings of Tier 1 instruction into practice.

The following year, Tier 1 oral language/reading instruction is implemented for another 12 months to a new cohort of Grade 1 students.

**Tier 2**
In term 2, Grade 1 students will be screened to identify those at-risk for language and reading difficulties and who will benefit from Tier 2 intervention. Based on the data from the screening assessment an appropriate Tier 2 intervention will be selected.

The screener will be chosen by the school with support from the ISP. An example of a screener is the year 1 phonics screening check which is a 7 min assessment done one on one between a student and teacher. The specific details of the screening assessment will depending on the screening product chosen by the school.

Tier 2 interventions will be targeted to small groups of these students and provide ability-based opportunities for them to learn and consolidate specific oral language and/or reading skills. We have conducted a systematic review of the literature to identify effective school-based Tier 2 interventions shown to improve oral language and/or reading outcomes for students during pre-school or early primary school (Goldfeld, S., et al. (in press). Tier 2 Oral Language and Early Reading Interventions for Preschool to Grade 2 Children: A Restricted Systematic Review. Australian Journal of Learning Difficulties). This publication found that the most effective interventions were typically characterised by the following procedural components: group size of approximately 3–5 students, meeting at least four times per week for sessions lasting approximately 30 minutes, with an overall duration of around 3 to 6 months.

The Tier 2 intervention will be chosen by the school with support of the ISP. The intervention chosen will depend on the needs of the Tier 2 students.

Tier 2 intervention will commence in Term 3 and progress monitoring will be undertaken at the end of Term 3 to identifiy which students can return to Tier 1 and which students require Tier 2 for Term 4. All Tier 2 students continue Tier 1 intervention throughout the year with the rest of the class. Tier 2 interventions are completed in addition to and alongside Tier 1 interventions.

The process of identifying and supporting Tier 2 students is repeated in the following year for 12 months to the new cohort of Grade 1 students. The Tier 2 intervention chosen in the second year of implementation will depend on the needs of the Tier 2 students in that year and is chosen by the school.

**Teacher professional learning**
To support fidelity of Tier 1 and Tier 2 implementation, teachers receive 6 professional learning sessions focused on evidence-based approaches to classroom oral language/reading instruction and key principles of RTI. This commences in week 2, Term 1 and consists of:
-4 sessions of the Science of Language and Reading short course (La Trobe University) for 4 consecutive weeks (2 options, online webinar or in person facilitated by ISP at each school)
-2 sessions about RTI and in-practice examples (online only, Zoom teleconference).

Teachers also receive support from an Implementation Support Partner (ISP) to reinforce their learning, support the implementation of classroom strategies and support the selection of screening and progress-monitoring tools and data interpretation. The ISP works with the school 1 day a week for the duration of the intervention. ISPs are speech pathologists or literacy support teachers who have been identified by the education sector organisations as being suitable and qualified for the ISP role. Teacher surveys and teaching records will be reviewed to assess intervention fidelity. Together teachers and ISPs aim to:
-map baseline oral language/reading/assessment/intervention practices at the school
-interpret and analyse data to determine oral language needs of students
-implement Tier 1 practice improvement (based on learnings from professional development)
-selection of screeners
-identify Tier 2 students
-identify suitable and evidence-based Tier 2 intervention
-progress monitoring of students

In the second year of implementation, professional learning is offer again and ISP support continues for another 12 months.
Intervention code [1] 322271 0
Early detection / Screening
Comparator / control treatment
No treatment. Cohort 2 schools run business as usual for year 1 (2022) and commence intervention in year 2 (2023). Grade 1 students in 2022 receive no intervention. Grade 1 students in 2023 receive the intervention. Grade 1 students in 2024 receive the intervention. Data collected from students in 2022 (business as usual) will be considered baseline.

Cohort 1 schools will implement RTI in year 1 (2022). Data collected for baseline will be done in 2022 Term 1, week 3-8. This overlaps with the beginning of the professional learning for teachers that occurs from week 2-8.

Control group
Active

Outcomes
Primary outcome [1] 329662 0
Change in student reading ability assessed using The Reading Progress Test (RPT)
Timepoint [1] 329662 0
Pre-intervention, After 12 months of intervention (start of Grade 2).
Secondary outcome [1] 403342 0
Change in student oral language ability assessed using The Clinical Evaluation of Language Fundamentals – Australian and New Zealand standardised Fifth Edition 1 x Subtest: Following Directions
Timepoint [1] 403342 0
Pre-intervention, After 12 months of intervention (start of Grade 2).
Secondary outcome [2] 403343 0
Change in student oral language ability assessed using CUBED: Narrative Language Measures (NLM) listening subtest,
Timepoint [2] 403343 0
Pre-intervention, After 12 months of intervention (start of Grade 2).
Secondary outcome [3] 403344 0
Change in student reading ability assessed using Test of Word Reading Efficiency–Second Edition (TOWRE 2).
Timepoint [3] 403344 0
Pre-intervention, After 12 months of intervention (start of Grade 2).
Secondary outcome [4] 403345 0
Change in student reading ability assessed using Sutherland Phonological Awareness Test (SPAT): phonemic awareness subtests.
Timepoint [4] 403345 0
Pre-intervention, After 12 months of intervention (start of Grade 2).
Secondary outcome [5] 403459 0
Change in teacher knowledge of language & reading constructs assessed using teacher knowledge survey.
Timepoint [5] 403459 0
Yearly during implementation for 2 years, knowledge survey administered after each oral language and reading professional learning session (4 sessions in total)
Secondary outcome [6] 403461 0
Fidelity of RTI implementation using schools PDSA Cycle data, qualitative focus groups and interviews.
Timepoint [6] 403461 0
Pre, 3 months after intervention, 12 months after intervention
Secondary outcome [7] 403462 0
Cost-consequence analysis to compare the incremental costs of the implementation (costs accrued in the intervention schools compared with costs accrued in the control schools) to the measured outcomes (e.g., student language).

Costs will include the material resources, staff time (participating teachers and ISPs) invested in providing all aspects of the implementation over the two-year period and travel related expenses, recorded prospectively by the research team. Teacher report of all professional learning activities and school-based interventions over and above the implementation of this RTI approach will be used to assess whether the intervention is associated with a reduction (cost-saving) in other professional activities.

Costs will be valued in Australian dollars in the 2022 reference year. The uncertainty of some relevant cost estimates will be tested in a sensitivity analysis.
Timepoint [7] 403462 0
24 months after intervention commencement.

Eligibility
Key inclusion criteria
Schools will be randomly assigned to cohort only if they meet all of the inclusion criteria.
• School population is at least 200 students
• Grade 1 cohort in 2022 is at least 35 students
• School ICSEA value is 1070 or less
• Schools 2018 AEDC results – language and cognitive domain vulnerability rate of equal or greater than 10%

First round Expression of Interest offers will be sent to schools with the above named criteria.
Minimum age
No limit
Maximum age
No limit
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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools will be randomly assigned to either Cohort 1 or Cohort 2. Cohort 1 commences the intervention implementation in the first year of the main study (2022). Cohort 2 acts as the control group, conducting ‘business as usual’, in the first year and then commences the intervention in the second year of the study (2023).

All Grade 1 students at a school allocated to Cohort 1 will receive the intervention starting 2022. All Grade 1 students at a school allocated to Cohort 2 will not receive the intervention until 2023.

A statistician independent from the trial will prepare the randomisation schedule using block randomisation to maintain balance between cohorts. Randomisation will then be stratified by school sector and Department of Education and Training (DET) region with variable block sizes (CEM schools, Victorian DET North East region schools, Victorian DET North West region schools). Schools to be randomised will be ordered alphabetically by school name within each education sector.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
Existing trials in schools show moderate to large effects (effect sizes of 0.2–0.4 standard deviations (SDs)) (M. A. (2020). Interpreting effect sizes of education interventions. Educational Researcher, 49(4), 241-253) for outcomes such as child reading and language development, from the early years of primary school. Given the primary objectives of the trial and measures collected in existing RCTs, we chose to anchor our sample size calculation around detection of a minimum effect size of 0.28 SD in reading comprehension measured via the Reading Progress Test at the start of Grade 2, this is a developmentally appropriate time to expect adequate reading comprehension.

The sample size calculation was performed for the effect of the intervention on the primary outcome (Reading Progress Test at the start of Grade 2) using “The Shiny CRT Calculator: Power and Sample size for Cluster Randomised Trials” (https://clusterrcts.shinyapps.io/rshinyapp/ ). We assumed the following: a standard deviation of 1, an intracluster correlation coefficient (ICC) of 0.02, Cluster auto-correlation (CAC) of 0.8, an alpha of 0.05. A total of 16 schools (8 schools in each cohort) and an average number of 35 students per year per school (who give consent and have primary outcome data available) will be required to detect an effect size of 0.28 SD on the Reading Progress Test score between intervention and control groups with a power of 80%. To account for potential drop-out of up to 2 schools during the duration of the study, we will recruit 18 schools in total (9 in each cohort).

If none of the 18 schools drop out from the study, an average of 30 students per year per school will be enough to detect a difference of 0.28 SD on the Reading Progress Test score between groups with a power of 80%.

Statistical analysis:
In order to compare intervention and control groups for primary and secondary outcomes, statistical methods will take into account time effects, clustering, and repeated measures.
The primary outcome (Reading Progress Test) and secondary outcomes will be calculated for each cell in the stepped wedge design by aggregating over all students measures in each school during each school year.

Linear mixed model will be used for continuous outcomes (including the primary outcome), adjusting for age, gender, and school year (i.e. secular trend). The cluster effect by school and correlation between repeated measurements on the same student over time will be taken into account in the multilevel analysis. Equivalent generalised linear mixed model will be used for categorical outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310219 0
Charities/Societies/Foundations
Name [1] 310219 0
Eureka Benevolant Foundation (EBF)
Country [1] 310219 0
Australia
Funding source category [2] 310249 0
Government body
Name [2] 310249 0
Victorian Government Department of Education and Training
Country [2] 310249 0
Australia
Funding source category [3] 310250 0
Other
Name [3] 310250 0
Melbourne Archdiocese Catholic Schools
Country [3] 310250 0
Australia
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
Royal Children's Hospital
50 Flemington Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 311314 0
None
Name [1] 311314 0
Address [1] 311314 0
Country [1] 311314 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309902 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 309902 0
The Royal Children's Hospital
Level 4, South Building
50 Flemington Road
Parkville Vic 3052
Ethics committee country [1] 309902 0
Australia
Date submitted for ethics approval [1] 309902 0
Approval date [1] 309902 0
28/10/2019
Ethics approval number [1] 309902 0

Summary
Brief summary
Oral language development in the early years of school is a developmental measure that is strongly linked to a broad range of outcomes including literacy, social skills, friendships, prosocial problem solving and conflict resolution skills, self-esteem, school attachment and subsequently mental health. In addition, students who do not master the basics of literacy in the early years of school struggle academically and may face a range of behavioural, social, vocational, and social-emotional difficulties into adolescence and adulthood. Focused efforts to improve oral language skills in the early years of school should lead to gains in literacy skills, social and emotional wellbeing, and academic trajectories.

The single most important ’in-school’ factor impacting on student outcomes is the quality of teaching. Therefore, to improve oral language skills for children and confer the benefits for child social development and mental health, there needs to a paralleled improved quality of teaching. Response to intervention (RTI) is a model that can provide universal access to high quality classroom instruction in language and reading for all students, while providing intensive intervention for those students identified as at-risk (i.e. the intensity is proportional to the needs of individual students).

The aim of this study is to use a RTI approach to improve oral language and reading instruction targeted to the early years of school, with a focus on:
- Tier 1, addressing the whole of class, universal provision of quality instruction; and
- Tier 2 interventions, addressing the needs of students most at-risk regarding their language and reading progress.

This study is not designed to test the effectiveness of each component of the intervention separately. Rather, we propose testing the processes and impact of implementation of an intervention system in the ‘real world’ and how that can improve oral language competency. The mixed methods research design will innovatively combine:
(1) a staged roll-out to determine impact,
(2) a detailed implementation methodology to ensure that the interventions are implemented and sustained within a school system over time, and
(3) qualitative data to investigate the barriers and facilitators to success.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115774 0
Prof Sharon Goldfeld
Address 115774 0
The Royal Children's Hospital
50 Flemington Road
Parkville, Victoria 3052 Australia
Country 115774 0
Australia
Phone 115774 0
+61 3 9345 6408
Fax 115774 0
Email 115774 0
[email protected]
Contact person for public queries
Name 115775 0
Melissa Cheah
Address 115775 0
The Royal Children's Hospital
50 Flemington Road
Parkville, Victoria 3052 Australia
Country 115775 0
Australia
Phone 115775 0
+61 3 9936 6030
Fax 115775 0
Email 115775 0
[email protected]
Contact person for scientific queries
Name 115776 0
Sharon Goldfeld
Address 115776 0
The Royal Children's Hospital
50 Flemington Road
Parkville, Victoria 3052 Australia
Country 115776 0
Australia
Phone 115776 0
+61 3 9345 6408
Fax 115776 0
Email 115776 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
Not covered by our ethics.


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.