Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00680303




Registration number
NCT00680303
Ethics application status
Date submitted
15/05/2008
Date registered
20/05/2008
Date last updated
20/05/2008

Titles & IDs
Public title
Spacing Lidcombe Program Clinic Visits
Scientific title
The Effect of Spacing of Lidcombe Program Clinic Visits
Secondary ID [1] 0 0
402763
Secondary ID [2] 0 0
402763-17
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: 1 - The child will receive the Lidcombe Program 2x per week

Experimental: 2 - The child will receive the Lidcombe Program once every 2 weeks (fortnightly visits)

Other: 3 - The child will receive the standard Lidcombe Program once per week (control)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
1. Number of clinic visits required to achieve Stage II (0-1%SS, Severity Rating=1) 2. Number of clinic days to achieve Stage II 3. Percent Syllables Stuttered (%SS) at entry to Stage II
Timepoint [1] 0 0
Entry into Stage II
Secondary outcome [1] 0 0
Parent reported Severity Ratings (SR)
Timepoint [1] 0 0
Pre-treatment, entry into Stage 2, 9 months post-randomization, 18 months post-randomization

Eligibility
Key inclusion criteria
1. 3;0-5;11 years of age
2. Stuttering for longer than 6 months
3. Functional English spoken by parent and child
4. Stuttering over 2%SS in one Beyond Clinic measure
5. Diagnosis of stuttering
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Less than 2%SS
2. Previous treatment for stuttering in last 6 months
3. Parental report of ADHD or intellectual disability

Study design
Purpose of the study
Other
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?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2010
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Newcastle - Newcastle
Recruitment postcode(s) [1] 0 0
2308 - Newcastle
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Newcastle University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Mark Onslow
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mark Onslow
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00680303