Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06403007 |
| Other study ID # |
2023-195 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 31, 2024 |
| Est. completion date |
August 31, 2027 |
Study information
| Verified date |
May 2024 |
| Source |
York University |
| Contact |
Robert S Savage, PhD |
| Phone |
437 2212603 |
| Email |
robert.savage[@]edu.yorku.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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, 4.5% 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 2/Tier 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' (e.g., 'cat') that do follow standard phonics rules
and for 'exceptions' (e.g., '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 (e.g., 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 al.'s (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 (e.g., moderating effects of prior
attainment) and why? (e.g., 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 80,90, 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 (i.e., 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
_________________________________________________________________
A sample of 100 schools gives us an acceptable MDES of 0.258.
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.
doi:10.1111/1467-9817.12325
Savage, R.S., 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:
10.1080/10888438.2018.1427753
