Spacing Lidcombe Program Clinic Visits

May 15, 2008 updated by: University of Sydney

The Effect of Spacing of Lidcombe Program Clinic Visits

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.

Study Overview

Status

Unknown

Conditions

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?

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
The child will receive the Lidcombe Program 2x per week
Experimental: 2
The child will receive the Lidcombe Program once every 2 weeks (fortnightly visits)
Other: 3
The child will receive the standard Lidcombe Program once per week (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Entry into Stage II

Secondary Outcome Measures

Outcome Measure
Time Frame
Parent reported Severity Ratings (SR)
Time Frame: Pre-treatment, entry into Stage 2, 9 months post-randomization, 18 months post-randomization
Pre-treatment, entry into Stage 2, 9 months post-randomization, 18 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mark Onslow, University of Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 15, 2008

First Posted (Estimate)

May 20, 2008

Study Record Updates

Last Update Posted (Estimate)

May 20, 2008

Last Update Submitted That Met QC Criteria

May 15, 2008

Last Verified

April 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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