Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001111662
Ethics application status
Approved
Date submitted
7/10/2014
Date registered
20/10/2014
Date last updated
20/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sight word and phonics training in children with poor reading
Scientific title
The effect of phonics and sight-word reading treatment on word reading accuracy, fluency, and comprehension in children who are poor readers
Secondary ID [1] 285456 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reading impairment 293229 0
Dyslexia 293230 0
Poor reading 293231 0
Condition category
Condition code
Mental Health 293499 293499 0 0
Learning disabilities
Other 293500 293500 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phonics treatment trained letter recognition, parsing, letter-sound rules, and blending. Sight-word treatment trained children to associate written irregular words (i.e., those that do not follow the letter-sound rules) with the appropriate pronunciations. These skills were trained using software programs. Children trained at home for 30 minutes per day, 5 days per week, for 8 weeks.

There were two treatment groups. Group 1 did no treatment (8 weeks) followed by phonics training (8 weeks) followed by sight word training (8 weeks). Group 2 did the same except the order of training was reversed (i.e., they did sight word training before phonics training). There was one week between interventions. An extended washout period was not required.
Intervention code [1] 290390 0
Treatment: Other
Comparator / control treatment
This study used a double-baseline control. At the start of the study, each child in each group completed the outcomes measures (Time 1). After 8 weeks of *no* treatment, they redid the same tests (Time 2). We subtracted their scores at Time 1 from Time 2 to reveal "non-training" effects (e.g., test-retest effects, regression to the mean effects, maturation effects) on each test. In our analyses, we compared gains over each treatment periods to these non-training effects. Gains were only considered to be valid treatment effects if they were statistically significantly larger than the non-training effects.
Control group
Active

Outcomes
Primary outcome [1] 293318 0
Castles and Coltheart 2 Nonword Reading Test
Timepoint [1] 293318 0
At Time 1, Time 2 (after 8 weeks of no treatment; baseline control), Time 3 (after 8 weeks of phonics training or sight word training), and at Time 4 (after a further 8 weeks of phonics training or sight word training).
Primary outcome [2] 293319 0
Castles and Coltheart 2 Irregular-word Reading test
Timepoint [2] 293319 0
At Time 1, Time 2 (after 8 weeks of no treatment; baseline control), Time 3 (after 8 weeks of phonics training or sight word training), and at Time 4 (after a further 8 weeks of phonics training or sight word training).
Primary outcome [3] 293320 0
The Test of Everyday Reading Comprehension (TERC)
Timepoint [3] 293320 0
At Time 1, Time 2 (after 8 weeks of no treatment; baseline control), Time 3 (after 8 weeks of phonics training or sight word training), and at Time 4 (after a further 8 weeks of phonics training or sight word training).
Secondary outcome [1] 310790 0
Test of Word Reading Efficiency (TOWRE) Sight Word Efficiency and TOWRE Phonetic Decoding Efficiency
Timepoint [1] 310790 0
At Time 1, Time 2 (after 8 weeks of no treatment; baseline control), Time 3 (after 8 weeks of phonics training or sight word training), and at Time 4 (after a further 8 weeks of phonics training or sight word training).
Secondary outcome [2] 310792 0
Diagnostic Spelling Test for Nonwords (DiSTn)
Timepoint [2] 310792 0
At Time 1, Time 2 (after 8 weeks of no treatment; baseline control), Time 3 (after 8 weeks of phonics training or sight word training), and at Time 4 (after a further 8 weeks of phonics training or sight word training).
Secondary outcome [3] 310793 0
Diagnostic Spelling Test for Irregular Words (DiSTi)
Timepoint [3] 310793 0
At Time 1, Time 2 (after 8 weeks of no treatment; baseline control), Time 3 (after 8 weeks of phonics training or sight word training), and at Time 4 (after a further 8 weeks of phonics training or sight word training).

Eligibility
Key inclusion criteria
Children who have (1) English as their first language, (2) no problems with attention, hearing, sight, or behaviour, and (3) poor reading for their age (i.e., their ability to read nonwords or irregular words - as measured by the Castles and Coltheart 2 Reading Test - was below the average range (a z scores lower than -1) for their age).
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Poor attention, poor hearing, poor visual acuity, severe developmental delay

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children with nonword or irregular word reading accuracy below the average range (i.e., below the 16th percentile) were allocated to Group 1 or 2 using minimisation (1:1; age, nonword reading accuracy, irregular word reading accuracy), which is considered by CONSORT to be equivalent to randomisation for trials with less than 100 participants.

Minimisation was executed by the lead research assistant using MinimPy. Group allocation was stored in a centralised database. Children were subsequently tested by another research assistant who was (1) unaware of group allocation, and (2) did not test the same child twice within the study. Children and their parents were unaware of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children were allocated to Group 1 or 2 using minimisation (1:1; age, nonword reading accuracy, irregular word reading accuracy), which is considered by CONSORT to be equivalent to randomisation for trials with less than 100 participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
To determine if there was a reliable difference between 8 weeks of phonics and sight word training, we used a between-group ANCOVA (controlling for each group’s corresponding non-training gains) to compare Time 1-Time 3 gains for each group. To determine if different orders of training had different effects on each outcome, we used a between-groups ANCOVA (controlling for non-training gains) to compare Time 1-Time 4 gains for each group.

Size of groups was determined based on outcomes of previous group studies of case studies suggesting that phonics training would have large effects on reading skills that depended heavily on phonics skills (d =0.8) and sight word training would have large effects on reading skills that depended on recognising whole words from memory (d = 0.8). With a power of 0.8, this equates to at least 26 children per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/01/2012
Date of last participant enrolment
Anticipated
Actual
31/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8808 0
2000 - Sydney
Recruitment postcode(s) [2] 8812 0
2100 - North Manly
Recruitment postcode(s) [3] 8813 0
2200 - Bankstown
Recruitment postcode(s) [4] 8814 0
2150 - Parramatta
Recruitment postcode(s) [5] 8815 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 290064 0
Government body
Name [1] 290064 0
National Health and Medical Research Council (NHMRC)
Country [1] 290064 0
Australia
Funding source category [2] 290065 0
Government body
Name [2] 290065 0
Australia Research Council (ARC)
Country [2] 290065 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Department of Cognitive Science
Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 288754 0
Other
Name [1] 288754 0
ARC Centre of Excellence in Cognition and its Disorders
Address [1] 288754 0
Macquarie University
NSW 2109
Country [1] 288754 0
Australia
Other collaborator category [1] 278179 0
Commercial sector/Industry
Name [1] 278179 0
Literacy Planet
Address [1] 278179 0
3/23 Main St
Varsity Lakes QLD 4227
Australia
Country [1] 278179 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291769 0
Macquarie University Ethics Secretariat
Ethics committee address [1] 291769 0
Ethics committee country [1] 291769 0
Australia
Date submitted for ethics approval [1] 291769 0
04/12/2007
Approval date [1] 291769 0
11/12/2007
Ethics approval number [1] 291769 0
HE28SEP2007-R05411

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

Contacts
Principal investigator
Name 51942 0
A/Prof Genevieve McArthur
Address 51942 0
Department of Cognitive Science
Macquarie University NSW 2109
Country 51942 0
Australia
Phone 51942 0
+61 2 9850 9162
Fax 51942 0
Email 51942 0
[email protected]
Contact person for public queries
Name 51943 0
Genevieve McArthur
Address 51943 0
Department of Cognitive Science
Macquarie University NSW 2109
Country 51943 0
Australia
Phone 51943 0
+61 2 9850 9162
Fax 51943 0
Email 51943 0
[email protected]
Contact person for scientific queries
Name 51944 0
Genevieve McArthur
Address 51944 0
Department of Cognitive Science
Macquarie University NSW 2109
Country 51944 0
Australia
Phone 51944 0
+61 2 9850 9162
Fax 51944 0
Email 51944 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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