Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000486820
Ethics application status
Not yet submitted
Date submitted
30/04/2012
Date registered
3/05/2012
Date last updated
3/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Literacy across languages in bilingual children: Can intervention in one language improve literacy skills in both languages?
Scientific title
Examination of cross-linguistic intervention effects of phonological awareness intervention on literacy skills in German-English bilingual children
Secondary ID [1] 280424 0
Nil
Universal Trial Number (UTN)
U1111-1130-3434
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Literacy 286394 0
Condition category
Condition code
Mental Health 286647 286647 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Speech pathology intervention in English
Participants will receive 12 hours of phonological awareness intervention administered by a Speech Pathologist in small groups of 2 - 3 children over a period of 6 weeks (2 x 1 hour per week)
Intervention code [1] 284778 0
Treatment: Other
Comparator / control treatment
Same intervention as intervention group except in German
Control group
Active

Outcomes
Primary outcome [1] 287051 0
The primary objective of the proposed research is to examine the effectiveness of an intervention approach for bilingual children to improve their literacy skills. The following Primary Outcome Measures will be utilised. - Clinical Evaluation of Language Fundamentals 4th Edition, Australian Standardised Edition (CELF-4 Australian; Semel, Wiig, & Secord, 2006), a widely used standardised broad-spectrum language assessment. - Comprehensive Test Of Phonological Processing (Wagner & Torgesen, 1999), a standardised phonological awareness measure for children aged 5 to 21 years. - The Neale Analysis of Reading Ability 3rd Edition (Neale, 1999), a norm referenced reading assessment of connected text. This assessment measures reading accuracy and reading comprehension - Patholinguistische Diagnostik bei Sprachentwicklungsstoerungen (Kauschke & Siegmueller, 2003) - Test fuer Phonologische Bewusstheitsfaehigkeiten (Fricke & Schaefer, 2008) - Salzburger Lese- und Rechtschreibtest II (Moll & Landerl, 2010) - Hamburger Schreibprobe (May, 2002) - Basiskompetenzen fuer Lese-Rechtschreibleistungen 1-4 (Stock, Marx & Schneider, 2003) - Experimental probes for PA, reading and spelling
Timepoint [1] 287051 0
There will be four testing occasions: - Pre-test 1 at start of the study - Pre-test 2 after a 8 week break to establish a baseline - Post-test immediately after the completion of the intervention - Follow up test: 8 weeks following the completion of post-tests
Secondary outcome [1] 297271 0
The secondary objective of the proposed research is to examine the relationships between the bilingual children's language skills and how their skills relate across their languages. The same assessments as described in the primary outcome will be used to assess these relationships via correlation analyses.
Timepoint [1] 297271 0
These analyses will be conducted after the completion of all follow-up assessments.

Eligibility
Key inclusion criteria
Participants need to meet the following inclusion criteria:
Bilingual in English and German
Attending prep to year 2
Literacy difficulties or language difficulties
Minimum age
5 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nonverbal intellectual abilities 1 SD or more below Mean

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285179 0
Government body
Name [1] 285179 0
Deutsche Forschungsgemeinschaft (German Research Foundation)
Country [1] 285179 0
Germany
Primary sponsor type
Other
Name
Murdoch Childrens Research Insitute
Address
Flemington Road,
Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 284047 0
None
Name [1] 284047 0
Address [1] 284047 0
Country [1] 284047 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287186 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 287186 0
Ethics committee country [1] 287186 0
Australia
Date submitted for ethics approval [1] 287186 0
04/05/2012
Approval date [1] 287186 0
Ethics approval number [1] 287186 0

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

Contacts
Principal investigator
Name 34125 0
Address 34125 0
Country 34125 0
Phone 34125 0
Fax 34125 0
Email 34125 0
Contact person for public queries
Name 17372 0
Naomi Katharina Zens
Address 17372 0
Language, Learning and Literacy Level 5, West building Murdoch Childrens Research Institute Flemington Road, Parkville, VIC 3052
Country 17372 0
Australia
Phone 17372 0
+61420468854
Fax 17372 0
Email 17372 0
[email protected]
Contact person for scientific queries
Name 8300 0
Naomi Katharina Zens
Address 8300 0
Language, Learning and Literacy Level 5, West building Murdoch Childrens Research Institute Flemington Road, Parkville, VIC 3052
Country 8300 0
Australia
Phone 8300 0
+61420468854
Fax 8300 0
Email 8300 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.