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/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
BEHAVIORAL - SMS (Short Message Service) reminders

Experimental: 1 - SMS reminders

No intervention: 2 - control group


BEHAVIORAL: SMS (Short Message Service) reminders
SMS reminders sent every 2 weeks
Intervention code [1] 0 0
BEHAVIORAL
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
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
Trial website
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

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/NCT00709072