Viewing Study NCT06403007



Ignite Creation Date: 2024-05-11 @ 8:30 AM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06403007
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-07
First Post: 2024-04-23

Brief Title: Tackling Two of the Most Important Unresolved Tasks in Reading Intervention
Sponsor: York University
Organization: York University

Study Overview

Official Title: Tackling Two of the Most Important Unresolved Tasks in Reading Intervention
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: An important question in education is how to help young children who struggle to learn to read despite being well-taught in their regular classrooms Many of the children with low reading ability also come from disadvantaged backgrounds

There is not a lot of evidence on how to support children with low reading ability become better readers This is especially true when children still have low reading ability despite experiencing attempts to teach them in both their regular whole class and then in small groups As a result in this study we will explore the best ways of training teachers to use programs that we have developed to support reading for these children who have not responded well to earlier teaching this is one of the tough jobs in our project title These programs have several new elements One element is teaching morphology Morphology means shared word meanings such as the shared meanings between words like sign design signal and signature Another element is called set-for-variability This means teaching children to have mental flexibility in using relationships between letters and sounds to read English We will run our study to see whether including these new elements leads to children with low reading ability improving their reading By doing this we will help children teachers and families and also contribute to a science of reading

To achieve these goals we will carry out two phases of study In phase 1 we will randomly allocate 50 schools to one condition where we will teach morphology and 50 schools to the other condition where we will teach set-for-variability In all schools we will also encourage teachers to teach children to use the relationships between letters and sounds to read words This is called phonics Doing such work and still having impact in a large number of schools is a major challenge This is the second of the tough jobs referred to in our project title In each school we will come in and train teachers of grade 1 and 2 children how to use our programs and focusing on the children who have low reading ability In the second part of the study we will work with a smaller set of children in Grade 3 who still have low reading ability despite our earlier work In this latter case the groups of children may be both smaller in number and the teaching may go on for longer to have an effect
Detailed Description: Overview

Poor readers face many risks Low-literate children are at higher risk of attention difficulties socio-emotional and mental health issues including low self-esteem learned helplessness anxiety depression suicidal ideation self-harm drug abuse and other health risks Multiple socio-economic risks emerge from low literacy as well We thus plan to extend programmatic work with a sub-set of the same sample of children we have worked with at Tier 1 effective whole class into Tier 2 supplemental small group reading intervention and then Tier 3 further extended supplemental intervention to examine how to use two promising interventions to solve one of the lingering challenges in reading intervention - improving reading of treatment non-responders in real school contexts run by regular teachers We plan to take on the second unresolved task in reading intervention impact at scale by running this as a scaled up randomised control trial RCT in around 100 schools in multiple school boards in Quebec Alberta and Ontario Canada

Interventions and intervention responsiveness

The literature on Response-to-Intervention RtI documenting effective Tier 1 and Tier 2 early reading interventions studies suggests that an explicit pedagogical focus on both the grapho-phonemic and morphological aspects of the written English facilitate reading attainment In previous work Georgiou 2016-21 Savage 2012-17 we contributed to this literature by working with a sample of children in Alberta and Quebec Georgiou 2022 Georgiou et al 2021 Savage et al 2018 2020 In these projects we helped over 95 of students to become typical readers However 45 of children in our sample continued to struggle despite interventions Such children have been labeled treatment resistors Blachman 1994 More work is needed on these promising theory-driven interventions at tier 2 A very modest research base exists on interventions for these children at tier 3 where intensive sustained small group or individual literacy tutoring is deployed in RtI models Al Otaiba et al 2014 identified only nine reasonably well-executed studies Griffiths and Stuart 2013 described only promising case studies Arias-Gundín and Llamazares 2021 systematically reviewed tiered interventions and reported finding three mixed Tier 2Tier 3 interventions and six Tier 3 interventions About half of the reported studies produced no significant treatment effects Arguably if these children did not benefit from existing interventions the need for new theorised approaches is clear

Theoretical contrasts in the 2 study arms

Both arms of our RCT receive phonics instruction because this is a well-evidenced approach Fletcher et al 2022 The two arms differ in the other part of their content These elements and the rationale are described below

Theoretical contrast in Arm 1 Set-for-Variability SfV

SfV involves mental flexibility in applying phonics to word reading While many children learn SfV without explicit instruction this may not be the case for treatment non-responders who struggle with phonic blending vocabulary and matching blended pronunciations to known word pronunciations Edwards et al 2021 Tunmer and Chapman 2012 In SfV phonic blending is broken into two teachable components 1 assembly of a phoneme string such as c-a-t from the printed word cat and 2 matching of this string to a known oral word pronunciation cat followed by smooth orchestration of the two processes The second process is rarely taught in standard phonics approaches In our model SfV is an explicitly taught strategy Savage et al 2022 Word-specific vocabulary is taught because vocabulary and synthetic phonic blending are co-requisites to effective SfV use SfV is a generative strategy for text reading that directly aids self-teaching Share 1995 because SfV works both for words typically deemed regular eg cat that do follow standard phonics rules and for exceptions eg go he wasp that do not follow the standard phonics rules SfV also aids reading comprehension Savage et al 2018

Research has shown that sustained SfV intervention improves word reading and reading comprehension outcomes in Tier 2 interventions in multi-site trials run by graduate students for at-risk students in Grade 1 Savage et al 2018 and the benefits may transfer to French in dual-language French Immersion instruction contexts Côté et al 2021 We have also reported data on large scaled Tier 1 and 2 trials run by teachers and educational assistants in authentic school contexts in Grades 1 2 and 3 in Alberta Georgiou 2022 Georgiou et al 2021 and Reception kindergarten and Grade 1 in England Savage et al 2022 showing clear effects of intervention on reading accuracy and comprehension However while we have promising data from Tier 2 and 3 trials run by trained graduate students no data exists on Tier 2 and 3 SfV interventions after foundational vocabulary and phonological processes have first been supported and on external validity trials where the intervention is run by regular teachers There is also a need to establish effects of a comprehensive SfV intervention alone Colenbrander et al 2022 Most existing SfV interventions involve other distinct simultaneously delivered components eg Lovett et al 2000 Our delivery of SfV thus pinpoints unique effects of this variable on reading outcomes reading accuracy We specifically expect effects on reading regular and exception words and on measures of SfV itself between pre and post-tests

Theoretical contrast in Arm 2 Morphology

Attention to teaching morphology may be crucial because of the allegedly morpho-phonemic nature of written English Venezky 1977 and the role morphology may play in word reading and reading comprehension development Kirby and Bowers 2017 Levesque et al 2021 Prior intervention trials and systematic reviews suggest replicable effects in both typical and atypical readers Goodwin and Ahn 2010 2013 Galuschka et als 2020 meta-analysis of all well-designed interventions for older struggling readers suggests that effects of morphology-focused interventions may be stronger than phonics-focused interventions However Galuschka et al caution against drawing strong conclusions due the modest number of well-executed studies currently available Few morphology studies have been placed within a research RtI model at either tier 2 or tier 3 Indeed there exist relatively few teacher-delivered morphology interventions and some morphological interventions have been reported to be a challenge for teachers to implement Colenbrander et al 2018 hence trials run by teachers in authentic school contexts are needed Finally we further explore individual differences in responsiveness to morphological interventions Georgiou et al 2021 Savage et al 2023 We specifically expect effects on reading polysyllabic words and on measures of morphological awareness itself between pre and post-tests

Study design

We thus seek to evaluate an Ontario- Quebec- and Alberta-based 2-arm Randomized Control Implementation Trial of an RtI model The interventions we will share in Quebec Ontario and Alberta are based on proven Alberta site implementation Dunn et al 2024 that has now impacted policy We extend this logic here to include the teachers of at-risk and older persistently poor readers tier 2 and tier 3 interventions across provincial sites

In our tier 2 we will contrast professional development PD in phonics morphology with PD in phonics strategy set-for-variability based interventions in a 2-arm trial In our tier 3 phase of the study children in the two trial arms will receive more sustained intervention including professional development PD content derived from the multi-componential interventions run earlier in Alberta contrasting phonics plus morphology with phonics plus set-for-variability

We will use our proven models of effective sustained PD delivery with loops of multi-component supports for practice Bell et al 2022 McNally et al 2019 Savage et al 2013 2022 in both intervention arms in both tiers of study

The research questions for Studies 1 and 2 are

Question 1 What are the effects of bringing PD on morphology and SfV to bear respectively to help teachers improve reading in Grades 2 and 3 for students who are poor readers and non-responsive to sustained evaluated evidenced school-wide Tier 1 interventions at tier 2 and where needed in Grade 3 at tier 3

Question 2 Can we scale up these interventions using extensive teacher PD and support with effects across trial sites in Quebec Alberta and Toronto school boards

We will also explore who responds to intervention eg moderating effects of prior attainment and why eg mediating effects of morphology and SfV

Theory of change

Our theory of change is an explicit causal one that tests the claim that our professional development to teachers on instruction in phonics plus set-for-variability then delivered by teachers in their regular classrooms impacts word reading outcomes through children showing improved use of phonic decoding in word reading and set for variability abilities Cascading effects may be evident in reading comprehension subsequently

Our theory of change is an explicit causal one that also tests the claim that our professional development to teachers on instruction in phonics plus morphology then delivered by teachers in their regular classrooms impacts word reading outcomes through children showing improved use of phonic decoding and morphological abilities Cascading effects may be evident in reading comprehension subsequently

Power calculation

We used Power up Dong and Maynard 2013 to assess power for school samples of 8090 and 100 The latter is described below

There are eight key factors associated with statistical power of particular study samples and sample size requirements to achieve a specified statistical power in nested designs

1 T he minimum relevant size impact MDES the smallest size impact it is important to detect if it exists
2 The adopted level of statistical significance α or probability of making a Type I error ie concluding there is an impact when there really is not Commonly evaluators set alpha equal to 05
3 Desired level of statistical power 1-β where β is the probability of making a Type II error failing to detect a true impact if it occurs Commonly evaluators adopt a power level of 80
4 use of one-tailed or two-tailed testing with two-tailed testing being most common
5 Use covariates to reduce measurement error Bloom 2006 Bloom et al 2007
6 Assumption of fixed or random effects across sample blocks or clusters which relates to the intended application of the study findings
7 Intraclass Correlation ICC
8 Average cluster size

Table 1 Specific assumptions of our calculations

1 1
2 Alpha 05
3 Beta 8
4 Two-tail
5 53 post-test 44 delayed post-test
6 Random
7 54
8 8 8

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A sample of 100 schools gives us an acceptable MDES of 0258

Selected References

Georgiou G Savage R Dunn K Bowers P and Parrila R 2021 Examining the effects of Structured Word Inquiry on the reading and spelling skills of persistently poor grade 3 readers Journal of Research in Reading 44 1 131-153 doi1011111467-981712325

Savage RS Georgiou G Parrila R and Maiorino K 2018 Preventative reading interventions teaching direct mapping of graphemes in texts and set-for-variability aid at-risk learners Scientific Studies of Reading 22 225-247 doi 1010801088843820181427753

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None