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Spacing Lidcombe Program Clinic Visits

Primary Purpose

Stuttering

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
The Lidcombe Program for early stuttering
The Lidcombe Program for early stuttering
The Lidcombe Program for early stuttering
Sponsored by
University of Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stuttering focused on measuring Early Stuttering, Lidcombe Program, Stuttering Treatment, Efficiency, Efficacy, Service Delivery, Models of intervention

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 3;0-5;11 years of age
  2. Stuttering for longer than 6 months
  3. Functional English spoken by parent and child
  4. Stuttering over 2%SS in one Beyond Clinic measure
  5. Diagnosis of stuttering

Exclusion Criteria:

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

Sites / Locations

  • University of NewcastleRecruiting
  • The Montreal Fluency CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

1

2

3

Arm Description

The child will receive the Lidcombe Program 2x per week

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Parent reported Severity Ratings (SR)

Full Information

First Posted
May 15, 2008
Last Updated
May 15, 2008
Sponsor
University of Sydney
Collaborators
National Health and Medical Research Council, Australia, Newcastle University
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1. Study Identification

Unique Protocol Identification Number
NCT00680303
Brief Title
Spacing Lidcombe Program Clinic Visits
Official Title
The Effect of Spacing of Lidcombe Program Clinic Visits
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sydney
Collaborators
National Health and Medical Research Council, Australia, Newcastle University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Stuttering is a communicative disorder that affects an estimated 5.19% of children. Although approximately 71.4% of children whose stuttering onset is in the preschool years exhibit spontaneous recovery within two years after first reported onset, there remain a significant number of children who require fluency intervention. Given the potential for negative long term social and communicative consequences due to persistent stuttering, there is a consensus among speech-language pathologists that stuttering should be treated early. However, the longer a child's stuttering persists, the less likely the child will spontaneously recover. The Lidcombe Program is a behavioral therapy program for preschool children designed to treat stuttering at its early stages. The treatment approach involves the direct participation of parents, who are trained during parent and child weekly visits to a speech language pathologist. In the first stage of the program, the clinician demonstrates the therapy to the parent, observes the parent conduct therapy and provides feedback and goals for the following week until the next clinic visit. The clinician guides the parent to provide three types of verbal "reinforcement" contingencies for the child's stutter free speech. These include, acknowledgment, praise and request for self-evaluation, where the child is asked to recognize his or her stutter free speech. If unambiguous stuttering occurs, the parent provides two types of verbal "punishment" contingencies including acknowledgment of the stuttering and request for self-correction, where the child is asked to repeat the stuttered word again. These contingencies are administered by parents in everyday speaking conversations, in order to promote generalization of fluent speech. When the child's stuttering is reduced to near-zero levels, the child then enters the second stage of the program, where the number of clinic visits are gradually phased out from bi-monthly to monthly to every 2 months, and so on, as required by the child. The purpose of the stage 2 visits is for the speech language pathologist to evaluate the child's speech and to ensure that near-zero stuttering levels are maintained. When the first stage of the Lidcombe program is followed as the program was originally designed, the median treatment time to achieve the criteria of near-zero levels of stuttering is 11 one-hour weekly clinic visits, with treatment times varying according to the severity of the stuttering. However, clinicians have been deviating from the standard weekly sessions for various reasons. For instance, some private practitioners are offering first stage treatment visits once every 2 weeks rather than weekly and other practitioners are offering treatment intensively, so that clients from remote areas can have access to the Lidcombe program. As yet, there are no data to confirm whether treatment using fortnightly or twice weekly clinic visits is as effective or efficient as the standard weekly visits. The aim of this project is to evaluate the following questions: (1) Does altering the spacing of LP clinic visits affect treatment efficiency? (2) Does altering the spacing of LP clinic visits affect treatment efficacy?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering
Keywords
Early Stuttering, Lidcombe Program, Stuttering Treatment, Efficiency, Efficacy, Service Delivery, Models of intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
The child will receive the Lidcombe Program 2x per week
Arm Title
2
Arm Type
Experimental
Arm Description
The child will receive the Lidcombe Program once every 2 weeks (fortnightly visits)
Arm Title
3
Arm Type
Other
Arm Description
The child will receive the standard Lidcombe Program once per week (control)
Intervention Type
Behavioral
Intervention Name(s)
The Lidcombe Program for early stuttering
Intervention Type
Behavioral
Intervention Name(s)
The Lidcombe Program for early stuttering
Intervention Type
Behavioral
Intervention Name(s)
The Lidcombe Program for early stuttering
Primary Outcome Measure Information:
Title
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
Time Frame
Entry into Stage II
Secondary Outcome Measure Information:
Title
Parent reported Severity Ratings (SR)
Time Frame
Pre-treatment, entry into Stage 2, 9 months post-randomization, 18 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 3;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 Exclusion Criteria: Less than 2%SS Previous treatment for stuttering in last 6 months Parental report of ADHD or intellectual disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Onslow
Email
M.Onslow@usyd.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Hewat
Email
Sally.Hewat@newcastle.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Onslow
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2308
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sally Hewat
Phone
61-2-4921 5159
Email
Sally.Hewat@newcastle.edu.au
First Name & Middle Initial & Last Name & Degree
Sarita Koushik
Phone
61-2-4921-6414
Email
Sarita.Koushik@studentmail.newcastle.edu.au
Facility Name
The Montreal Fluency Centre
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosalee Shenker
Phone
514-489-4320
Email
Rosalee@montrealfluency.com

12. IPD Sharing Statement

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Spacing Lidcombe Program Clinic Visits

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