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Trial registered on ANZCTR


Registration number
ACTRN12610000140055
Ethics application status
Not yet submitted
Date submitted
4/02/2010
Date registered
11/02/2010
Date last updated
11/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing and treating children with phonological dyslexia using a phonics-based intervention
Scientific title
The effect of phonics based reading treatment on the reading skills of children with phonological dyslexia
Secondary ID [1] 1390 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reading impairments (phonological dyslexia) 256747 0
Condition category
Condition code
Mental Health 256902 256902 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The phonics based reading treatment will train parsing, letter-sound rules, and blending. These skills will be trained using an online reading program and thus, children will complete their reading training at home on their home computers under parental supervision. Children will train for 30 minutes per day, 5 days per week, for 3 weeks.
Intervention code [1] 255964 0
Treatment: Other
Comparator / control treatment
The study uses a double-baseline control. At the start of the study each child completes the reading and language tests (Test 1). After 8 weeks of NO treatment, they are re-tested on the same tests (Test 2). We then subtract their scores at Test 1 from Test 2 to reveal their test-retest effects on each test. We then subtract these test-retest effects from each child's subsequent improvements on the tests (i.e., at Test 3 after 3 weeks of training, at Test 4 after another 3 weeks of training, at Test 5 after another 3 weeks of training and lastly at Test 6 after the last 3 weeks of additional training). This allows us to determine how much each child improved due to training alone (i.e., excluding test-retest effects).
Control group
Active

Outcomes
Primary outcome [1] 257773 0
Castles and Coltheart 2 Nonword Reading Test
Timepoint [1] 257773 0
At Test 1, Test 2 (after 8 weeks of NO treatment; baseline control), Test 3 (after 3 weeks of parsing training), Test 4 (after 3 weeks of letter-sound rule training), Test 5 (after 3 weeks of blending training), and Test 6 (after 3 weeks of additional general phonics training).
Primary outcome [2] 257774 0
Castles and Coltheart 2 Irregular Word Reading Test
Timepoint [2] 257774 0
At Test 1, Test 2 (after 8 weeks of NO treatment; baseline control), Test 3 (after 3 weeks of parsing training), Test 4 (after 3 weeks of letter-sound rule training), Test 5 (after 3 weeks of blending training), and Test 6 (after 3 weeks of additional general phonics training).
Primary outcome [3] 257775 0
A newly developed (non-commercial) Brief Arithmetic Test (BAT) that assesses the ability to complete simple mathematical computations including addition, subtraction, multiplication, and division.
Timepoint [3] 257775 0
At Test 1, Test 2 (after 8 weeks of NO treatment; baseline control), Test 3 (after 3 weeks of parsing training), Test 4 (after 3 weeks of letter-sound rule training), Test 5 (after 3 weeks of blending training), and Test 6 (after 3 weeks of additional general phonics training).
Secondary outcome [1] 263176 0
Test of Word Reading Efficiency (TOWRE) Sight Word Efficiency and Phonetic Decoding Efficiency.
Timepoint [1] 263176 0
At Test 1, Test 2 (after 8 weeks of NO treatment; baseline control), Test 3 (after 3 weeks of parsing training), Test 4 (after 3 weeks of letter-sound rule training), Test 5 (after 3 weeks of blending training), and Test 6 (after 3 weeks of additional general phonics training).
Secondary outcome [2] 263177 0
Phonological recoding subskills (letter identfication, parsing, letter-sound conversion, blending).
1) Letter identification and parsing will be assessed using paper and pencil tests.
2) Letter-sound conversion will be assessed using flashcards. The child will be asked to name the letter-sound when shown a flashcard with a letter on it.
3) Blending will be assessed using auditory blending task (similar to the blending task in the Comprehensive Test of Phonological Processing (CTOPP).
Timepoint [2] 263177 0
At Test 1, Test 2 (after 8 weeks of NO treatment; baseline control), Test 3 (after 3 weeks of parsing training), Test 4 (after 3 weeks of letter-sound rule training), Test 5 (after 3 weeks of blending training), and Test 6 (after 3 weeks of additional general phonics training).
Secondary outcome [3] 263178 0
Test of Everyday Reading Comprehension
Timepoint [3] 263178 0
At Test 1, Test 2 (after 8 weeks of NO treatment; baseline control), Test 3 (after 3 weeks of parsing training), Test 4 (after 3 weeks of letter-sound rule training), Test 5 (after 3 weeks of blending training), and Test 6 (after 3 weeks of additional general phonics training).
Secondary outcome [4] 263179 0
The Kohnen Spelling Test for Nonwords and the Kohnen Spelling Test for Irregular Words
Timepoint [4] 263179 0
At Test 1, Test 2 (after 8 weeks of NO treatment; baseline control), Test 3 (after 3 weeks of parsing training), Test 4 (after 3 weeks of letter-sound rule training), Test 5 (after 3 weeks of blending training), and Test 6 (after 3 weeks of additional general phonics 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 are screened for their reading accuracy for nonwords and irregular words. If they fall below the average range on nonword reading but within or above the average range on irregular word reading they fit the criteria for the study. There is only one treatment group so no allocation will be required and all participants act as their own control (double-baseline).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2544 0
2000
Recruitment postcode(s) [2] 2545 0
2010
Recruitment postcode(s) [3] 2546 0
2020
Recruitment postcode(s) [4] 2547 0
2030
Recruitment postcode(s) [5] 2548 0
2040

Funding & Sponsors
Funding source category [1] 256464 0
University
Name [1] 256464 0
Macquarie University
Country [1] 256464 0
Australia
Primary sponsor type
University
Name
Macquarie Centre for Cognitive Science (MACCS)
Address
Macquarie Centre for Cognitive Science (MACCS)
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country
Australia
Secondary sponsor category [1] 255773 0
None
Name [1] 255773 0
Address [1] 255773 0
Country [1] 255773 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258519 0
Macquarie University Ethics Secretariat - pending approval until registered with ANZCTR
Ethics committee address [1] 258519 0
Ethics committee country [1] 258519 0
Australia
Date submitted for ethics approval [1] 258519 0
11/11/2009
Approval date [1] 258519 0
Ethics approval number [1] 258519 0
HE27NOV2009-D00013

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

Contacts
Principal investigator
Name 30801 0
Address 30801 0
Country 30801 0
Phone 30801 0
Fax 30801 0
Email 30801 0
Contact person for public queries
Name 14048 0
Linda Larsen
Address 14048 0
MACCS
Macquarie University
NSW 2109
Country 14048 0
Australia
Phone 14048 0
+61 2 9850 4136
Fax 14048 0
+61 2 9850 6059
Email 14048 0
linda.larsen@maccs.mq.edu.au
Contact person for scientific queries
Name 4976 0
Linda Larsen
Address 4976 0
MACCS
Macquarie University
NSW 2109
Country 4976 0
Australia
Phone 4976 0
+61 2 9850 4136
Fax 4976 0
+61 2 9850 6059
Email 4976 0
linda.larsen@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
No additional documents have been identified.