Spacing Lidcombe Program Clinic Visits

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by University of Sydney.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Newcastle University
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00680303
First received: May 15, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Stuttering
Behavioral: The Lidcombe Program for early stuttering
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Effect of Spacing of Lidcombe Program Clinic Visits

Resource links provided by NLM:


Further study details as provided by University of Sydney:

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 [ Time Frame: Entry into Stage II ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parent reported Severity Ratings (SR) [ Time Frame: Pre-treatment, entry into Stage 2, 9 months post-randomization, 18 months post-randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The child will receive the Lidcombe Program 2x per week
Behavioral: The Lidcombe Program for early stuttering
Experimental: 2
The child will receive the Lidcombe Program once every 2 weeks (fortnightly visits)
Behavioral: The Lidcombe Program for early stuttering
3
The child will receive the standard Lidcombe Program once per week (control)
Behavioral: The Lidcombe Program for early stuttering

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?

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680303

Contacts
Contact: Mark Onslow M.Onslow@usyd.edu.au
Contact: Sally Hewat Sally.Hewat@newcastle.edu.au

Locations
Australia, New South Wales
University of Newcastle Recruiting
Newcastle, New South Wales, Australia, 2308
Contact: Sally Hewat    61-2-4921 5159    Sally.Hewat@newcastle.edu.au   
Contact: Sarita Koushik    61-2-4921-6414    Sarita.Koushik@studentmail.newcastle.edu.au   
Canada, Quebec
The Montreal Fluency Centre Recruiting
Montreal, Quebec, Canada
Contact: Rosalee Shenker    514-489-4320    Rosalee@montrealfluency.com   
Sponsors and Collaborators
University of Sydney
National Health and Medical Research Council, Australia
Newcastle University
Investigators
Principal Investigator: Mark Onslow University of Sydney
  More Information

No publications provided

Responsible Party: Professor Mark Onslow, Australian Stuttering Research Centre, The University of Sydney
ClinicalTrials.gov Identifier: NCT00680303     History of Changes
Other Study ID Numbers: 402763-17, 402763
Study First Received: May 15, 2008
Last Updated: May 15, 2008
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by University of Sydney:
Early Stuttering
Lidcombe Program
Stuttering Treatment
Efficiency
Efficacy
Service Delivery
Models of intervention

Additional relevant MeSH terms:
Stuttering
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014