Follow-up of Children After Stuttering Treatment | NCT00709072

Studies
Follow-up of Children After Stuttering Treatment

NCT00709072

Sponsor

University of Sydney

Status

Unknown status

Last Update Posted

Apr 26, 2010Estimated

Enrollment

180Estimated

Phase

Phase 2

Conditions

Stuttering

Interventions

SMS (Short Message Service) reminders

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Jul 1, 2008

First Submission Date that Met QC Criteria

Jul 2, 2008

First Posted Date

Jul 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2010

Last Update Posted Date

Apr 26, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	SMS reminders	Behavioral: SMS (Short Message Service) reminders
2	No Intervention	control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SMS (Short Message Service) reminders	Behavioral	SMS reminders sent every 2 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of syllables stuttered		six monthly for three years

Secondary Outcomes

Measure	Description	Time Frame
parent reported stuttering severity		six monthly for three years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Onslow, PhD	University of Sydney	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Australian Stuttering Research Centre	Recruiting	Sydney	New South Wales	1825	Australia

Condition Browse Module

MeSH Terms

ID	Term
D013342	Stuttering
D012008	Recurrence

Ancestor Terms

ID	Term
D013064	Speech Disorders
D007806	Language Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013097	Spermine Synthase

Ancestor Terms

ID	Term
D019883	Alkyl and Aryl Transferases
D014166	Transferases
D004798	Enzymes
D045762	Enzymes and Coenzymes

Browse Leaves

Not provided

Browse Branches

Not provided