Back to resultsFollow-up of Children After Stuttering Treatment
Primary Purpose
Stuttering
Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
SMS (Short Message Service) reminders
Sponsored by
About this trial
This is an interventional prevention trial for Stuttering focused on measuring stuttering, relapse, Lidcombe Program, Preschool children
Eligibility Criteria
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
Sites / Locations
- Australian Stuttering Research CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
SMS reminders
control group
Outcomes
Primary Outcome Measures
percentage of syllables stuttered
Secondary Outcome Measures
parent reported stuttering severity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00709072
Brief Title
Follow-up of Children After Stuttering Treatment
Official Title
Relapse Following the Lidcombe Program for Preschool Children Who Stutter
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sydney
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Stuttering treatment becomes more time-consuming and less effective as children become older. Therefore it is crucial to prevent relapse following treatment in the early years. This study will investigate predictors of relapse and assess the effectiveness of a simple two-weekly user-friendly reminder to parents, about when and how to address any re-occurring stuttering after treatment. Results from the study may help to prevent stuttering relapse in this age group in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering
Keywords
stuttering, relapse, Lidcombe Program, Preschool children
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
SMS reminders
Arm Title
2
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Behavioral
Intervention Name(s)
SMS (Short Message Service) reminders
Intervention Description
SMS reminders sent every 2 weeks
Primary Outcome Measure Information:
Title
percentage of syllables stuttered
Time Frame
six monthly for three years
Secondary Outcome Measure Information:
Title
parent reported stuttering severity
Time Frame
six monthly for three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Onslow, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Australian Stuttering Research Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
1825
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Onslow, PhD
Phone
61 2 9351 9061
Email
M.Onslow@usyd.edu.au
12. IPD Sharing Statement
Learn more about this trial
Follow-up of Children After Stuttering Treatment
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