NCT00709072

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 26, 2010

Status Verified

June 1, 2009

Enrollment Period

2.8 years

First QC Date

July 1, 2008

Last Update Submit

April 22, 2010

Conditions

Stuttering

Keywords

stutteringrelapseLidcombe ProgramPreschool children

Outcome Measures

Primary Outcomes (1)

  • percentage of syllables stuttered

    six monthly for three years

Secondary Outcomes (1)

  • parent reported stuttering severity

    six monthly for three years

Study Arms (2)

1

EXPERIMENTAL

SMS reminders

Behavioral: SMS (Short Message Service) reminders

2

NO INTERVENTION

control group

Interventions

SMS (Short Message Service) remindersBEHAVIORAL

SMS reminders sent every 2 weeks

1

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Completion of stage I of Lidcombe Program
  • Less than 1 percent syllables stuttered at recruitment
  • Means of receiving SMS email or phone reminder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Australian Stuttering Research Centre

Sydney, New South Wales, 1825, Australia

RECRUITING

MeSH Terms

Conditions

StutteringRecurrence

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Alkyl and Aryl TransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Mark Onslow, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 3, 2008

Study Start

February 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 26, 2010

Record last verified: 2009-06

Locations

AU(1)