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Trial registered on ANZCTR


Registration number
ACTRN12614000855628
Ethics application status
Approved
Date submitted
29/07/2014
Date registered
8/08/2014
Date last updated
8/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of an intensive pronunciation program on improving diverse students’ communication skills
Scientific title
For speech pathology students from Culturally and Linguistically Diverse (CALD) background, does an intensive pronunciation intervention targeting prosody and articulation improve speech intelligibility and acceptability?
Secondary ID [1] 285072 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Speech impairment 292602 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292910 292910 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a phase one clinical trial.
Each participant will attend 3 sessions per week for 3 weeks during the baseline and treatment phase. Follow up sessions will be conducted once a week for 3 weeks following the end of the treatment phase. This is a total of 21 sessions.

Mode of administration:
1) Baseline phase: 3 x 50 minute individual sessions per week for 3 weeks. All sessions will be administered by speech pathology students supervised by a qualified speech pathologist.

2) Treatment phase: 2 x 50 minute individual sessions per week, plus 1 x 50 minute group session per week for 3 weeks (total of 9 sessions). All sessions will be administered by speech pathology students supervised by a qualified speech pathologist.

3) Follow up phase: 1 x 50 minute individual sessions per week for 3 weeks. All sessions will be administered by speech pathology students supervised by a qualified speech pathologist.

Treatment method:
Treatment for articulation (target sounds selection) will be dependent on participants’ assessment results and the intervention approach will be based on Principles of Motor Learning (Maas, Robin, Hula et al, 2008). Prosody training will focus on lexical stress. The treatment program will use Perfect Pronunciation (Kimble-Fry, 2012) as a guide for articulation and prosody production. Treatment will be in 2 phases: pre-practice and practice phase. Goal criterion is 90% accuracy. Participants will be provided with target words practice at word and sentence level. Data of target words production will be recorded. Once the participant is able to achieve 90% accuracy in the pre-practice phase, she/he will continue to the practice phase.

3) Interrater reliability checks will be conducted each week of treatment.
Intervention code [1] 289911 0
Treatment: Other
Comparator / control treatment
This is a phase one study to determine if this treatment is effective. It is a single case study design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292778 0
Primary outcome 1: speech intelligibility measured in words and sentences using the Assessment of Intelligibility of Dysarthric Speech (AIDS) - Sentences subtest

Timepoint [1] 292778 0
Timepoint: at baseline, once weekly during treatment, and 1, 2, and 3 weeks post treatment.
Secondary outcome [1] 309667 0
Secondary outcome 1: pragmatic skills as judged by their clinicians pre and post treatment on a visual analogue scale
Timepoint [1] 309667 0
Timepoint: at baseline and 1, 2, and 3 weeks post treatment

Eligibility
Key inclusion criteria
Speech pathology students at the University of Sydney who have failed a communication screener, a clinical placement or been identified as being at risk of failure will be invited to participate. Students must be from culturally and linguistically diverse backgrounds which includes:
* Students who were born overseas, enrolled as international students
* Students who were born overseas who have migrated to Australia as a child, adolescent or young person, enrolled as domestic students
* Students who were born in Australia to parents who were born overseas (including a child of a refugee)
* Students who were born in Australia to parents who were born in Australia but speak another language at home or in their community, or a dialect of English that is common and acceptable in their cultural community
* Aboriginal or Torres Strait Islander Australian
* Students who speak a language other than English as their first language or main language
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion:
CALD speech pathology students who are not at risk of failing a clinical placement or who have not failed a communication screener or a clinical placement.

Students who were born in Australia to parents and grandparents who were born in Australia and who do not identify themselves as being culturally or linguistically diverse from mainstream English-speaking Australian culture
Australian-born students who identify themselves as part of mainstream Australian culture who are poor users and speakers of English

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)
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
Number of participants was determined by the average number of students who have failed a communication screener, a clinical placement or been identified as being at risk of failure. No power calculation will be conducted as this is a phase I single subject study. The effect size will be measured by standard mean difference and visual analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/08/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289680 0
University
Name [1] 289680 0
Australian Postgraduate Award from The University of Sydney
Country [1] 289680 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia

Country
Australia
Secondary sponsor category [1] 288373 0
None
Name [1] 288373 0
Address [1] 288373 0
Country [1] 288373 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291415 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [1] 291415 0
Ethics committee country [1] 291415 0
Australia
Date submitted for ethics approval [1] 291415 0
Approval date [1] 291415 0
17/06/2014
Ethics approval number [1] 291415 0
2014/526

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

Contacts
Principal investigator
Name 50278 0
Dr Alison Purcell
Address 50278 0
C42 - Cumberland Campus
The University of Sydney
East Street, Lidcombe
NSW 2141 Australia
Country 50278 0
Australia
Phone 50278 0
+61 2 9351 9335
Fax 50278 0
+61 2 9351 9173
Email 50278 0
[email protected]
Contact person for public queries
Name 50279 0
Annie Chan
Address 50279 0
C42 - Cumberland Campus
The University of Sydney
East Street, Lidcombe
NSW 2141 Australia
Country 50279 0
Australia
Phone 50279 0
+61 2 9351 9868
Fax 50279 0
+61 2 9351 9163
Email 50279 0
[email protected]
Contact person for scientific queries
Name 50280 0
Annie Chan
Address 50280 0
C42 - Cumberland Campus
The University of Sydney
East Street, Lidcombe
NSW 2141 Australia
Country 50280 0
Australia
Phone 50280 0
+61 2 9351 9868
Fax 50280 0
+61 2 9351 9163
Email 50280 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.