Follow-up of Children After Stuttering Treatment

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2009 by University of Sydney.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University of Sydney

ClinicalTrials.gov Identifier:

NCT00709072

First received: July 1, 2008

Last updated: April 22, 2010

Last verified: June 2009

History of Changes

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Relapse Following the Lidcombe Program for Preschool Children Who Stutter

Resource links provided by NLM:

MedlinePlus related topics: Stuttering Toddler Health

U.S. FDA Resources

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:	February 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 SMS reminders	Behavioral: SMS (Short Message Service) reminders SMS reminders sent every 2 weeks
No Intervention: 2 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
Australian Stuttering Research Centre	Recruiting
Sydney, New South Wales, Australia, 1825
Contact: Mark Onslow, PhD 61 2 9351 9061 M.Onslow@usyd.edu.au

Sponsors and Collaborators

University of Sydney

Investigators

Principal Investigator:

Mark Onslow, PhD

The University of Sydney

More Information

No publications provided

Responsible Party:	Professor Mark Onslow, The University of Sydney
ClinicalTrials.gov Identifier:	NCT00709072 History of Changes
Other Study ID Numbers:	10483
Study First Received:	July 1, 2008
Last Updated:	April 22, 2010
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by University of Sydney:

stuttering
relapse
Lidcombe Program
Preschool children

Additional relevant MeSH terms:

Stuttering
Speech Disorders
Language Disorders
Communication Disorders

Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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