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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/NCT00709072




Registration number
NCT00709072
Ethics application status
Date submitted
1/07/2008
Date registered
3/07/2008
Date last updated
26/04/2010

Titles & IDs
Public title
Follow-up of Children After Stuttering Treatment
Scientific title
Relapse Following the Lidcombe Program for Preschool Children Who Stutter
Secondary ID [1] 0 0
10483
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 - SMS (Short Message Service) reminders

Experimental: 1 - SMS reminders

No Intervention: 2 - control group


Behaviour: SMS (Short Message Service) reminders
SMS reminders sent every 2 weeks
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
percentage of syllables stuttered
Timepoint [1] 0 0
six monthly for three years
Secondary outcome [1] 0 0
parent reported stuttering severity
Timepoint [1] 0 0
six monthly for three years

Eligibility
Key inclusion criteria
- Completion of stage I of Lidcombe Program

- Less than 1 percent syllables stuttered at recruitment

- Means of receiving SMS email or phone reminder
Minimum age
3 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Prevention
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
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2011
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Australian Stuttering Research Centre - Sydney
Recruitment postcode(s) [1] 0 0
1825 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study aims to determine the percentage and predictors of stuttering relapse following
treatment with the Lidcombe Program. It will also investigate the effectiveness of sending
reminder messages to parents to assist in reducing relapse.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00709072
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Onslow, PhD
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00709072