Spacing Lidcombe Program Clinic Visits

Tracking Information
First Submitted Date ICMJE	May 15, 2008
First Posted Date ICMJE	May 20, 2008
Last Update Posted Date	May 20, 2008
Study Start Date ICMJE	January 2008
Estimated Primary Completion Date	December 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 15, 2008)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: May 15, 2008)	Parent reported Severity Ratings (SR) [ Time Frame: Pre-treatment, entry into Stage 2, 9 months post-randomization, 18 months post-randomization ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Spacing Lidcombe Program Clinic Visits
Official Title ICMJE	The Effect of Spacing of Lidcombe Program Clinic Visits
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?
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Health Services Research
Condition ICMJE	Stuttering
Intervention ICMJE	Behavioral: The Lidcombe Program for early stuttering
Study Arms	Experimental: 1 The child will receive the Lidcombe Program 2x per week Intervention: Behavioral: The Lidcombe Program for early stuttering; Experimental: 2 The child will receive the Lidcombe Program once every 2 weeks (fortnightly visits) Intervention: Behavioral: The Lidcombe Program for early stuttering; 3 The child will receive the standard Lidcombe Program once per week (control) Intervention: Behavioral: The Lidcombe Program for early stuttering
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: May 15, 2008)	120
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2010
Estimated Primary Completion Date	December 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	3 Years to 6 Years (Child)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Australia, Canada
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00680303
Other Study ID Numbers ICMJE	402763-17; 402763
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Professor Mark Onslow, Australian Stuttering Research Centre, The University of Sydney
Study Sponsor ICMJE	University of Sydney
Collaborators ICMJE	National Health and Medical Research Council, Australia; Newcastle University
Investigators ICMJE	Principal Investigator: Mark Onslow University of Sydney
PRS Account	University of Sydney
Verification Date	April 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP