NCT00680303

Brief Summary

The purpose of this study is to evaluate the efficiency of the Lidcombe Program for early stuttering by varying the time between clinic visits during the first stage of the program.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

Typical duration for phase_2

Geographic Reach
2 countries

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 20, 2008

Status Verified

April 1, 2008

Enrollment Period

1.9 years

First QC Date

May 15, 2008

Last Update Submit

May 15, 2008

Conditions

Keywords

Early StutteringLidcombe ProgramStuttering TreatmentEfficiencyEfficacyService DeliveryModels of intervention

Outcome Measures

Primary Outcomes (1)

  • 1. Number of clinic visits required to achieve Stage II (0-1%SS, Severity Rating=1) 2. Number of clinic days to achieve Stage II 3. Percent Syllables Stuttered (%SS) at entry to Stage II

    Entry into Stage II

Secondary Outcomes (1)

  • Parent reported Severity Ratings (SR)

    Pre-treatment, entry into Stage 2, 9 months post-randomization, 18 months post-randomization

Study Arms (3)

1

EXPERIMENTAL

The child will receive the Lidcombe Program 2x per week

Behavioral: The Lidcombe Program for early stuttering

2

EXPERIMENTAL

The child will receive the Lidcombe Program once every 2 weeks (fortnightly visits)

Behavioral: The Lidcombe Program for early stuttering

3

OTHER

The child will receive the standard Lidcombe Program once per week (control)

Behavioral: The Lidcombe Program for early stuttering

Interventions

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ;0-5;11 years of age
  • Stuttering for longer than 6 months
  • Functional English spoken by parent and child
  • Stuttering over 2%SS in one Beyond Clinic measure
  • Diagnosis of stuttering

You may not qualify if:

  • Less than 2%SS
  • Previous treatment for stuttering in last 6 months
  • Parental report of ADHD or intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Newcastle

Newcastle, New South Wales, 2308, Australia

RECRUITING

The Montreal Fluency Centre

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mark Onslow

    University of Sydney

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Onslow

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 20, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

May 20, 2008

Record last verified: 2008-04

Locations