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Trial registered on ANZCTR


Registration number
ACTRN12606000245594
Ethics application status
Approved
Date submitted
22/05/2006
Date registered
19/06/2006
Date last updated
19/06/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Literacy Pathway
Scientific title
Does binocular vision training enhance literacy among primary school children with poor reading?
Universal Trial Number (UTN)
Trial acronym
LP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Binocular vision 1222 0
Literacy 1223 0
Poor reading due to dyslexia or other conditions but excluding poor reading due to major intellectual disability. 1224 0
Condition category
Condition code
Eye 1306 1306 0 0
Diseases / disorders of the eye
Mental Health 1307 1307 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three intervention groups all with some efficacy. Interventions A and B will each be compared to C.

A. visual predominant/phonological training, 10 weeks ( one hour per week face to face, 6 hours a week homework)
B.phonological predominant/visual training , 10 weeks( one hour per week face to face, 6 hours a week homework)
Intervention code [1] 1063 0
Treatment: Other
Comparator / control treatment
C. parent-child educational program, 10 weeks (comparison intervention)( no face to face, 7 hours a week homework)
Control group
Active

Outcomes
Primary outcome [1] 1786 0
Reading
Timepoint [1] 1786 0
Measured at baseline, 10 weeks and 26 weeks
Primary outcome [2] 1787 0
Rate of reading test.
Woodcock Reading Mastery Test - Revised:
- Passage comprehension
- Letter identification
- Word identification
- Word attack
Timepoint [2] 1787 0
Measured at baseline, 10 weeks and 26 weeks
Secondary outcome [1] 3142 0
Visual acuity (3m LogMAR)
*Binocular
*Monocular
Stereotest
Lang test
Worth 4 dot
Near point of convergence
*Objective
*Subjective
Accommodative facility
Near vision
Timepoint [1] 3142 0
Vision, to be measured at baseline, 10 weeks and 26 weeks.
Secondary outcome [2] 3143 0
Developmental Eye Movement (DEM) test
d2 Test of Attention
Copying test – error rate per 100 words
Visual attention span
Timepoint [2] 3143 0
Visual Processing, to be measured at baseline, 10 weeks and 26 weeks.
Secondary outcome [3] 3144 0

Conner Parent Rating Score – Revised, short form
Conner Teacher Rating Score – Revised, short form
Timepoint [3] 3144 0
Attention Defict Hyperactivity Disorder (ADHD), to be measured at baseline, 10 weeks and 26 weeks.

Eligibility
Key inclusion criteria
Children in the lowest decile of literacy according to Grade 3 national literacy and numeracy tests who also have poor stereovision on screening assessment. Children must reside in Southern Tasmania (telephone 0362).
Minimum age
7 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major intellectual impairment or epilepsy.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. Block sizes are not variable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1433 0
Government body
Name [1] 1433 0
Australian Research Council
Country [1] 1433 0
Australia
Primary sponsor type
University
Name
Menzies Research Institute, University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 1264 0
University
Name [1] 1264 0
Faculty of Education, University of Tasmania
Address [1] 1264 0
Country [1] 1264 0
Australia
Secondary sponsor category [2] 1265 0
University
Name [2] 1265 0
Deapartment of Pediatrics and Child Health, University of Tasmania
Address [2] 1265 0
Country [2] 1265 0
Australia
Secondary sponsor category [3] 1266 0
Other
Name [3] 1266 0
Murdoch Childrens Research Institute
Address [3] 1266 0
Country [3] 1266 0
Australia
Secondary sponsor category [4] 1267 0
Government body
Name [4] 1267 0
Deapartment of Education, Tasmanian Government
Address [4] 1267 0
Country [4] 1267 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2806 0
Northern Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 2806 0
Ethics committee country [1] 2806 0
Australia
Date submitted for ethics approval [1] 2806 0
Approval date [1] 2806 0
12/04/2005
Ethics approval number [1] 2806 0
H0008202

Summary
Brief summary
Five to ten percent of primary school children fail to learn to read at the standard expected from their intelligence and educational and cultural background. This condition is known as dyslexia.

In 2005-2006, a dyslexia project is being conducted in participating Southern Tasmanian schools. Past work has shown that some children with normal intelligence have reading problems because of problems with coordinating both eyes to read visual images. The project aims to screen for vision coordination problems among children with low literacy. It is not currently known what proportion of children who have difficulty reading have vision problems in relation to scanning text with both eyes working together.

The main aim of the Literacy Pathways Project is:

To assess how children may benefit from different programs to assist them with reading. Each program contains a mixture of activities that are based on past work indicating that they have benefited some children with reading problems. The relative importance of the different components within or between the programs is currently not known and is the subject of the educational trial.

Participants are unaware of the intervention status and commercial names of the reading programs in the study. The programs are referred to as the orange, yellow or green program.
Participants are not aware of the content of the other programs. The people conducting the assessments are blind to intervention status.

Analysis - The true group allocation will be removed for the analysis and only added back in at the end. That is, the analyst will only analyse the data being aware of the orange, yellow or green categories but not the intervention status associated with each.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36031 0
Address 36031 0
Country 36031 0
Phone 36031 0
Fax 36031 0
Email 36031 0
Contact person for public queries
Name 10252 0
Prof Anne-Louise Ponsonby
Address 10252 0
Menzies Research Institute
University of Tasmania
GPO Box 23
Hobart TAS 7000
Country 10252 0
Australia
Phone 10252 0
+61 401678382
Fax 10252 0
+61 3 62267704
Email 10252 0
[email protected]
Contact person for scientific queries
Name 1180 0
Prof Anne-Louise Ponsonby
Address 1180 0
Menzies Research Institute
University of Tasmania
GPO Box 23
Hobart TAS 7000
Country 1180 0
Australia
Phone 1180 0
+61 401678382
Fax 1180 0
+61 3 62267704
Email 1180 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

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

Documents added automatically
No additional documents have been identified.