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Trial registered on ANZCTR


Registration number
ACTRN12609001008213
Ethics application status
Approved
Date submitted
17/11/2009
Date registered
20/11/2009
Date last updated
9/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
ABRACADABRA (ABRA) Improving Literacy through Technology
A Multisite Randomised Control Trial Examining the Impact of a Web-Based Early Literacy program on Student Literacy in the Northern Territory (NT)
Scientific title
The impact of ABRACADABRA (ABRA) web-based literacy instruction as compared to standard literacy instruction on the phonemic awareness and word reading of Northern Territory (NT) students in Transition, Year 1 and Year 2 classrooms.
Secondary ID [1] 252667 0
ABRACADABRA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low student literacy in the Northern Territory 252216 0
Condition category
Condition code
Other 252402 252402 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
Students will receive ABRACADABRA (ABRA) instruction for one semester (Semester 1, 2010) for a minimum of 30 minutes per day, 4 days per week up to a maximum of 1 hour per day, 5 days per week
.

Developed by a team of literacy and classroom technology experts at Concordia University, ABRA takes a balanced and flexible approach to reading instruction. ABRA includes 32 instructional activities embedded in 17 stories and provides instruc-tion in alphabetics, fluency, comprehension, writing and associated sub-skills (Hipps, Abrami, Savage, Cerna & Jorgenson, 2005). ABRA instruction begins by introducing the main characters and then reading age-appropriate stories. Story associated activities, such as rhyming, are then selected and students can work individually or in groups of varying sizes to answer questions. The ABRA tool is available at no cost at http://abralite.concordia.ca.

The ABRA intervention will be delivered by one of six trained registered teachers. Treatment students will leave their classrooms to attend ABRA lessons in separate rooms. The delivery medium will depend upon the schools’ available technologies, and may include interactive White Boards, computer labs and/or laptops. The registered teachers will be trained and intensively supported by a researcher during bi-weekly site visits to deliver ABRA according to best practice. The six ABRA teachers will collaborate on lesson design in order to ensure they are providing the same quality and type of instruction.
Intervention code [1] 241559 0
Other interventions
Comparator / control treatment
For the 30-45 minute daily ABRA lessons, students in the control group will receive lit-eracy instruction from their classroom teachers. Currently in the NT most students are taught literacy through three school-based approaches Accelerated Literacy (NALP, 2009), First Steps (2009) and Walking Talking Text (Murray, 1995).
Control group
Active

Outcomes
Primary outcome [1] 253278 0
Group Reading and Diagnostic Assessment and Evaluation (GRADE) K Phonological Awareness and Word Reading subscale posttest ability score (combined).
Timepoint [1] 253278 0
1) Pretest, weeks 3-4, Semester 1, 2010 : One to two weeks prior to the initiation of ABRACADABRA (ABRA) instruction and 2) Posttest, weeks 19-20, Semester 1, 2010: one to two weeks after ABRA instruction.
Secondary outcome [1] 262274 0
GRADE K phoneme-grapheme correspondence and early literacy skills subtest posttest ability scores.
Timepoint [1] 262274 0
1) Pretest, weeks 3-4, Semester 1, 2010 : One to two weeks prior to the initiation of ABRACADABRA (ABRA) instruction and 2) Posttest, weeks 19-20, Semester 1, 2010: one to two weeks after ABRA instruction.
Secondary outcome [2] 262275 0
Performance Indicators in Primary Schools (PIPS) reading posttest ability score
Timepoint [2] 262275 0
1) Pretest, weeks 3-4, Semester 1, 2010 : One to two weeks prior to the initiation of ABRACADABRA (ABRA) instruction and 2) Posttest, weeks 19-20, Semester 1, 2010: one to two weeks after ABRA instruction.
Secondary outcome [3] 262276 0
Performance Indicators in Primary Schools (PIPS) phonics posttest ability score
Timepoint [3] 262276 0
1) Pretest, weeks 3-4, Semester 1, 2010 : One to two weeks prior to the initiation of ABRACADABRA (ABRA) instruction and 2) Posttest, weeks 19-20, Semester 1, 2010: one to two weeks after ABRA instruction.
Secondary outcome [4] 262277 0
Performance Indicators in Primary Schools (PIPS) math posttest ability score
Timepoint [4] 262277 0
1) Pretest, weeks 3-4, Semester 1, 2010 : One to two weeks prior to the initiation of ABRACADABRA (ABRA) instruction and 2) Posttest, weeks 19-20, Semester 1, 2010: one to two weeks after ABRA instruction.
Secondary outcome [5] 262278 0
Raw scores on all GRADE K and PIPS total and subscale tests
Timepoint [5] 262278 0
1) Pretest, weeks 3-4, Semester 1, 2010 : One to two weeks prior to the initiation of ABRACADABRA (ABRA) instruction and 2) Posttest, weeks 19-20, Semester 1, 2010: one to two weeks after ABRA instruction.
Secondary outcome [6] 262279 0
Standard score change for all GRADE K and PIPS total and subscale tests per hour of intervention (response to intervention)
Timepoint [6] 262279 0
1) Pretest, weeks 3-4, Semester 1, 2010 : One to two weeks prior to the initiation of ABRACADABRA (ABRA) instruction, 2) Posttest, weeks 19-20, Semester 1, 2010: one to two weeks after ABRA instruction, 3) daily attendance will be used to calculate hours of exposure to ABRA instruction.

Eligibility
Key inclusion criteria
Students enrolled in Transition, Grade 1 or Grade 2 classrooms (or combination thereof)
Minimum age
4 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lack of reliable internet access within the students’ school

Schools with fewer than 60 students in Transition, Grade 1 and 2 classrooms

Schools with less than 30% Indigenous students

Students identified by the school as being non-testable due to severe cognitive impairment or unable to complete pretest assessment.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pre-randomisation
Schools will be asked to identify two to four classrooms to participate in the study so that the total number of students eligible for randomisation totals at least 60. Schools will be responsible for distributing consent forms to the parents of eligible study students. During the pre-randomisation phase schools will provide demographic information on the study students (gender, date of birth, Indigenous status, English as a Second Language (ESL) status, student ID and student name). This demographic information will be entered in a student database. During the pretesting period (weeks 3 and 4 of Semester 1) volunteer testers and research staff will assess the students on the phonological awareness, word reading, phoneme-grapheme correspondence and early literacy skills subscale of the GRADE K and the PIPS assessments. Students who do not complete pretests will be removed from the student database and excluded from randomisation.

Randomisation will use permuted blocks, stratified by school, class and class level within a class. A list of all eligible students and classrooms will be supplied to the Menzies School for Health Research for randomisation by classroom during week 4. Allocation will be concealed by 1) randomising after eligibility is determined and 2) supplying the student lists to the holder of the allocation schedule (Menzies School for Health Research) who is 'off-site' to create the allocation list. By week 5, schools will be informed which students will receive ABRA during Semester 1 and ABRA instruction will begin.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will use permuted blocks, stratified by school, class and class level within a class.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessors will be blind to student assignment.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2010
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] 244025 0
Government body
Name [1] 244025 0
Australian Research Council
Country [1] 244025 0
Australia
Funding source category [2] 244026 0
Charities/Societies/Foundations
Name [2] 244026 0
Telstra Foundation
Country [2] 244026 0
Australia
Primary sponsor type
University
Name
Charles Darwin University -- School for Social and Policy Research
Address
39 Ellengowan Drive
Building Yellow 1
Charles Darwin University
Darwin NT 0909
Country
Australia
Secondary sponsor category [1] 251373 0
None
Name [1] 251373 0
Address [1] 251373 0
Country [1] 251373 0
Other collaborator category [1] 960 0
University
Name [1] 960 0
Menzies School of Health Research
Address [1] 960 0
Building 58
Royal Darwin Hospital
Tiwi NT 0810
Country [1] 960 0
Australia
Other collaborator category [2] 961 0
University
Name [2] 961 0
Concordia University -- Centre for the Study of Learning and Performance
Address [2] 961 0
CSLP, LB-581
Concordia University,
1455 De Maisonneuve Blvd. West,
Montreal, Quebec
H3G 1M8
Country [2] 961 0
Canada
Other collaborator category [3] 962 0
University
Name [3] 962 0
National Health and Medical Research Council Clinical Trials Centre
Address [3] 962 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country [3] 962 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258131 0
Charles Darwin University Human Research Ethics Committee
Ethics committee address [1] 258131 0
Ethics committee country [1] 258131 0
Australia
Date submitted for ethics approval [1] 258131 0
Approval date [1] 258131 0
Ethics approval number [1] 258131 0

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

Contacts
Principal investigator
Name 30515 0
Address 30515 0
Country 30515 0
Phone 30515 0
Fax 30515 0
Email 30515 0
Contact person for public queries
Name 13762 0
Dr Helen Harper
Address 13762 0
School for Social and Policy Research
39 Ellengowan Drive
Yellow Building 1, Level 2
Darwin NT 0909
Country 13762 0
Australia
Phone 13762 0
+61 8 8946 6963
Fax 13762 0
Email 13762 0
Helen.harper@cdu.edu.au
Contact person for scientific queries
Name 4690 0
Dr Jennifer Wolgemuth
Address 4690 0
School for Social and Policy Research
39 Ellengowan Drive
Yellow Building 1, Level 2
Darwin NT 0909
Country 4690 0
Australia
Phone 4690 0
+61 8 8946 6963
Fax 4690 0
Email 4690 0
jenni.wolgemuth@cdu.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.