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Trial registered on ANZCTR


Registration number
ACTRN12609000709246
Ethics application status
Not yet submitted
Date submitted
12/08/2009
Date registered
17/08/2009
Date last updated
17/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing the Westmead Program and the Lidcombe Program treatments for preschool children who stutter.
Scientific title
Comparing the Westmead Program and the Lidcombe Program treatments for preschool children who stutter.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stuttering in preschool children. 243500 0
Condition category
Condition code
Other 239743 239743 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Westmead Program is conducted in two stages. During stage 1, children are taught to to practice a speech pattern known as syllable-timed speech (STS) with their parents, daily. STS involves speaking with equal stress attached to each syllable. The treatment is administered by a trained speech pathologist during weekly or fortnightly clinic visits, lasting 30-60 minutes in duration. Treatment continues until stuttering is less than 1.0% syllables stuttered within the clinic and average weekly severity rating scores beyond the clinic are less than 2, for three consecutive weeks. At that point, participants progress to Stage 2 of treatment. The aim of Stage 2 is to maintain the low level of stuttering achieved during Stage 1 whilst gradually withdrawing treatment over approximately one year. The Westmead Program treatment group will be run simultaneously to the Lidcombe Program treatment group.
Intervention code [1] 237062 0
Treatment: Other
Comparator / control treatment
The Lidcombe Program is conducted in two stages. During stage 1, parents are trained to provide verbal contingencies in response to their child’s speech. The verbal contingencies for stutter-free speech are acknowledgement, praise and request for self-evaluation. The verbal contingencies for stuttered-speech are acknowledgement and request for self correction. Parents are required to administer these contingencies daily, during 10-15 minute structured conversations. Along with providing contingencies in structured conversations, parents are also required to give on-line feedback to their child in a wide range of unstructured conversations, occurring at times other than the treatment session. The treatment is administered by a trained speech pathologist during weekly clinic visits, lasting 45-60 minutes in duration. Treatment continues until stuttering is less than 1.0% syllables stuttered within the clinic and average weekly severity rating scores beyond the clinic are less than 2, for three consecutive weeks. At that point, participants progress to Stage 2 of treatment. The aim of Stage 2 is to maintain the low level of stuttering achieved during Stage 1 whilst gradually withdrawing treatment over approximately one year. The Lidcombe Program treatment group will be run simultaneously to the Westmead Program treatment group.
Control group
Active

Outcomes
Primary outcome [1] 240496 0
Percent syllables stuttered (%SS). A %SS measure indicates the proportion of syllables in a speech sample that are associated with unambiguous stuttering. To calculate %SS, an electronic button press counter device will be used, where one button is pressed for each stuttered syllable and another pressed for every other syllable.
Timepoint [1] 240496 0
Pre-treatment, post-treatment, 9-months post randomisation.
Secondary outcome [1] 257043 0
Time taken to complete treatment. Treatment time measures included 1) the number of weeks required to complete Stage 1, 2) the number of clinic visits required to complete Stage 1 and 3) the total speech pathologist time associated with each clinic visit.
Timepoint [1] 257043 0
Post-treatment.

Eligibility
Key inclusion criteria
Stuttering for at least 6 months; stuttering severity greater than 2.0 %SS; no previous treatment for stuttering; no other speech or language disorders; functional spoken English.
Minimum age
1 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Stuttering for less than 6 months; stuttering severity less than 2.0 %SS; previous treatment for stuttering; other diagnosed speech or language disorders; non-functional spoken English.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1992 0
1825
Recruitment postcode(s) [2] 1993 0
2132
Recruitment postcode(s) [3] 1994 0
3052

Funding & Sponsors
Funding source category [1] 237438 0
Government body
Name [1] 237438 0
National Health and Medical Research Council
Country [1] 237438 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
GPO Box 1421,
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 236927 0
Other Collaborative groups
Name [1] 236927 0
Australian Stuttering Research Centre
Address [1] 236927 0
The University of Sydney,
PO Box 170,
Lidcombe NSW 1825
Country [1] 236927 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239563 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 239563 0
Ethics committee country [1] 239563 0
Australia
Date submitted for ethics approval [1] 239563 0
21/08/2009
Approval date [1] 239563 0
Ethics approval number [1] 239563 0
Ethics committee name [2] 239564 0
South Western Sydney Area Health Service Human Research Ethics Committee
Ethics committee address [2] 239564 0
Ethics committee country [2] 239564 0
Australia
Date submitted for ethics approval [2] 239564 0
21/08/2009
Approval date [2] 239564 0
Ethics approval number [2] 239564 0
Ethics committee name [3] 239565 0
Royal Children's Hospital Human Research Ethics Committee: Melbourne
Ethics committee address [3] 239565 0
Ethics committee country [3] 239565 0
Australia
Date submitted for ethics approval [3] 239565 0
21/08/2009
Approval date [3] 239565 0
Ethics approval number [3] 239565 0

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

Contacts
Principal investigator
Name 29856 0
Address 29856 0
Country 29856 0
Phone 29856 0
Fax 29856 0
Email 29856 0
Contact person for public queries
Name 13103 0
Natasha Trajkovski
Address 13103 0
Australian Stuttering Research Centre,
PO Box 170,
Lidcombe NSW 1825
Country 13103 0
Australia
Phone 13103 0
+61 2 93519061
Fax 13103 0
Email 13103 0
n.trajkovski@usyd.edu.au
Contact person for scientific queries
Name 4031 0
Professor Mark Onslow
Address 4031 0
Australian Stuttering Research Centre,
PO Box 170,
Lidcombe NSW 1825
Country 4031 0
Australia
Phone 4031 0
+61 2 93519061
Fax 4031 0
Email 4031 0
m.onslow@usyd.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.