Follow-up of Children After Stuttering Treatment

Stuttering Clinical Trial

Official title:

Relapse Following the Lidcombe Program for Preschool Children Who Stutter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00709072
• Other study ID #: 10483
• Status: Recruiting
• Phase: Phase 2
• First received: July 1, 2008
• Last updated: April 22, 2010
• Start date: February 2009
• Est. completion date: December 2011

Study information

• Verified date: June 2009
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stuttering

Intervention

Behavioral:
• SMS (Short Message Service) reminders
SMS reminders sent every 2 weeks

Locations

Country	Name	City	State
Australia	Australian Stuttering Research Centre	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of syllables stuttered		six monthly for three years	No
Secondary	parent reported stuttering severity		six monthly for three years	No