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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Behaviour - The Lidcombe Program for early stuttering
Behaviour - The Lidcombe Program for early stuttering
Behaviour - The Lidcombe Program for early stuttering

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)


Behaviour: The Lidcombe Program for early stuttering


Behaviour: The Lidcombe Program for early stuttering


Behaviour: The Lidcombe Program for early stuttering
Intervention code [1] 0 0
Behaviour
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
Health Services Research
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 status
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
The purpose of this study is to evaluate the efficiency of the Lidcombe Program for early
stuttering by varying the time between clinic visits during the first stage of the program.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00680303
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
M.Onslow@usyd.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00680303