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Trial registered on ANZCTR


Registration number
ACTRN12608000454370
Ethics application status
Approved
Date submitted
13/08/2008
Date registered
15/09/2008
Date last updated
8/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial of treatments for children with different types of reading difficulty
Scientific title
The effect of phonics and sight-word reading treatment on the reading skills of children with different types of reading impairment
Secondary ID [1] 285461 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reading impairment 3557 0
Dyslexia 293233 0
Poor reading 293234 0
Condition category
Condition code
Other 3712 3712 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Mental Health 293502 293502 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 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 three treatment groups. Group 1 did no treatment (8 weeks) followed by phonics treatment (8 weeks) followed by sight-word treatment (8 weeks). Group 2 did no treatment (8 weeks) followed by sight-word treatment (8 weeks) followed by phonics treatment (8 weeks). Group 3 did no treatment (8 weeks) followed by a mix of phonics and sight-word treatment (8 weeks) followed by the same mix of phonics and sight-word treatment (8 weeks). Trainees rested for one week between 8-week training periods.
Intervention code [1] 3270 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] 4615 0
Castles and Coltheart 2 Nonword Reading Test
Timepoint [1] 4615 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 or mixed training), and at Time 4 (after a further 8 weeks of phonics training or sight word training or mixed training).
Primary outcome [2] 4616 0
Castles and Coltheart 2 Irregular-word Reading test
Timepoint [2] 4616 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 or mixed training), and at Time 4 (after a further 8 weeks of phonics training or sight word training or mixed training).
Primary outcome [3] 4617 0
The Test of Everyday Reading Comprehension (TERC)
Timepoint [3] 4617 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 or mixed training), and at Time 4 (after a further 8 weeks of phonics training or sight word training or mixed training).
Secondary outcome [1] 7786 0
Test of Word Reading Efficiency (TOWRE) Sight Word Efficiency and TOWRE Phonetic Decoding Efficiency
Timepoint [1] 7786 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 or mixed training), and at Time 4 (after a further 8 weeks of phonics training or sight word training or mixed training).
Secondary outcome [2] 7787 0
phonological recoding subskills (letter identification, parsing, letter-sound conversion, blending)
Timepoint [2] 7787 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 or mixed training), and at Time 4 (after a further 8 weeks of phonics training or sight word training or mixed training).
Secondary outcome [3] 7789 0
The Diagnostic Spelling Test for Nonwords (DiSTn) and the Diagnostic Spelling Test for Irregular Words (DiSTi)
Timepoint [3] 7789 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 or mixed training), and at Time 4 (after a further 8 weeks of phonics training or sight word training or mixed 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.
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
Non-randomised 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, 2, or 3 using a quasi-randomised procedure based on time of enrolment (i.e., months 1 to 6 for Group 1, months 7 to 12 for Group 2 , and months 13 to 18 for Group 3).

If a child was deemed eligible for the study, the lead research assistant would allocate them to the appropriate group, which was stored in a centralised database. Subsequent testing of each child was done by another research assistants who were unaware of group allocation. No child was tested twice by the same research assistant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children were allocated to Group 1, 2, or 3 using a quasi-randomised procedure based on time of enrolment (i.e., months 1 to 6 for Group 1, months 7 to 12 for Group 2 , and months 13 to 18 for Group 3).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
1/10/2008
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
31/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1106 0
2000
Recruitment postcode(s) [2] 1107 0
2010
Recruitment postcode(s) [3] 1108 0
2020
Recruitment postcode(s) [4] 1109 0
2030
Recruitment postcode(s) [5] 1110 0
2040

Funding & Sponsors
Funding source category [1] 3735 0
Government body
Name [1] 3735 0
National Health and Medical Research Council (NHMRC)
Country [1] 3735 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Department of Cognitive Science
Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 3351 0
None
Name [1] 3351 0
Address [1] 3351 0
Country [1] 3351 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5788 0
Macquarie University Ethics Secretariat
Ethics committee address [1] 5788 0
Ethics committee country [1] 5788 0
Australia
Date submitted for ethics approval [1] 5788 0
04/12/2007
Approval date [1] 5788 0
11/12/2007
Ethics approval number [1] 5788 0
HE28SEP2007-R05411

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

Contacts
Principal investigator
Name 28843 0
A/Prof Genevieve McArthur
Address 28843 0
Department of Cognitive Science
ARC Centre of Excellence in Cognition and its Disorders
Macquarie University NSW 2109
Country 28843 0
Australia
Phone 28843 0
+61 2 9850 9162
Fax 28843 0
Email 28843 0
genevieve.mcarthur@mq.edu.au
Contact person for public queries
Name 12000 0
Genevieve McArthur
Address 12000 0
Department of Cognitive Science
ARC Centre of Excellence in Cognition and its Disorders
Macquarie University NSW 2109
Country 12000 0
Australia
Phone 12000 0
+61 2 9850 9162
Fax 12000 0
+61 2 9850 6059
Email 12000 0
genevieve.mcarthur@mq.edu.au
Contact person for scientific queries
Name 2928 0
Dr Genevieve McArthur
Address 2928 0
Department of Cognitive Science
ARC Centre of Excellence in Cognition and its Disorders
Macquarie University NSW 2109
Country 2928 0
Australia
Phone 2928 0
+61 2 9850 9162
Fax 2928 0
+61 2 9850 6059
Email 2928 0
genevieve.mcarthur@maccs.mq.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseReplicability of sight word training and phonics training in poor readers: A randomised controlled trial.2015https://dx.doi.org/10.7717/peerj.922
N.B. These documents automatically identified may not have been verified by the study sponsor.