Follow-up of Children After Stuttering Treatment - Full Text View

Sponsored by:	University of Sydney
Information provided by:	University of Sydney
ClinicalTrials.gov Identifier:	NCT00709072

Purpose

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.

Condition	Intervention	Phase
Stuttering	Behavioral: SMS (Short Message Service) reminders	Phase II

MedlinePlus related topics: Stuttering

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Relapse Following the Lidcombe Program for Preschool Children Who Stutter

Further study details as provided by University of Sydney:

Primary Outcome Measures:

percentage of syllables stuttered [ Time Frame: six monthly for three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

parent reported stuttering severity [ Time Frame: six monthly for three years ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental SMS reminders	Behavioral: SMS (Short Message Service) reminders SMS reminders sent every 2 weeks
2: No Intervention control group

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.

Eligibility

Ages Eligible for Study:	3 Years to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709072

Locations

Australia, New South Wales
The University of Sydney
Sydney, New South Wales, Australia

Sponsors and Collaborators

University of Sydney

Investigators

Principal Investigator:

Mark Onslow, PhD

The University of Sydney

More Information

Responsible Party:	The University of Sydney ( Professor Mark Onslow )
Study ID Numbers:	10483
Study First Received:	July 1, 2008
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00709072
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by University of Sydney:

stuttering
relapse
Lidcombe Program
Preschool children

Study placed in the following topic categories:

Signs and Symptoms
Speech Disorders
Neurologic Manifestations
Language Disorders

Stuttering
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009