- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680303
Spacing Lidcombe Program Clinic Visits
The Effect of Spacing of Lidcombe Program Clinic Visits
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Mark Onslow
- Email: M.Onslow@usyd.edu.au
Study Contact Backup
- Name: Sally Hewat
- Email: Sally.Hewat@newcastle.edu.au
Study Locations
-
-
New South Wales
-
Newcastle, New South Wales, Australia, 2308
- Recruiting
- University of Newcastle
-
Contact:
- Sally Hewat
- Phone Number: 61-2-4921 5159
- Email: Sally.Hewat@newcastle.edu.au
-
Contact:
- Sarita Koushik
- Phone Number: 61-2-4921-6414
- Email: Sarita.Koushik@studentmail.newcastle.edu.au
-
-
-
-
Quebec
-
Montreal, Quebec, Canada
- Recruiting
- The Montreal Fluency Centre
-
Contact:
- Rosalee Shenker
- Phone Number: 514-489-4320
- Email: Rosalee@montrealfluency.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Mark Onslow, University of Sydney
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 402763-17
- 402763
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.
Clinical Trials on Stuttering
-
University of Texas at AustinRecruitingStuttering | Stuttering, Childhood | Stuttering, Adult | Stuttering, DevelopmentalUnited States
-
University of MichiganNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingStuttering | Stuttering, Childhood | Stuttering, AdultUnited States
-
Biruni UniversityRecruitingStuttering, AdultTurkey
-
University of PittsburghUniversity of Michigan; National Institute on Deafness and Other Communication...Recruiting
-
University of MichiganNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingStuttering | Stuttering, ChildhoodUnited States
-
Riphah International UniversityCompletedStuttering, AdultPakistan
-
University of OxfordCompletedStuttering, DevelopmentalUnited Kingdom
-
Iran University of Medical SciencesCompletedStuttering/ DevelopmentalIran, Islamic Republic of
-
Assiut UniversityUnknownStuttering, Childhood
-
The Hong Kong Polytechnic UniversityCompletedStuttering, Adult | StammeringHong Kong
Clinical Trials on The Lidcombe Program for early stuttering
-
Children's Hospital of Fudan UniversityNational Key Research and Development Program of ChinaCompletedAutism Spectrum Disorder | Attention Deficit-Hyperactivity Disorder | Global Developmental Delay | Brain Developmental DiseasesChina
-
National Taiwan University HospitalNot yet recruitingHypopharyngeal Pressure Changes Between Before and After Swallowing Rehabiliation
-
Assiut UniversityNot yet recruiting
-
Boston University Charles River CampusNational Institute of Mental Health (NIMH)CompletedSchizophrenia | Schizoaffective Disorder | Bipolar Disorder | Major Depression | Chronic Mental DisorderUnited States
-
Lin XuCompletedAcute Myocardial Infarction
-
Mayo ClinicCompleted
-
Gazi UniversityNot yet recruitingCaregivers With a Child Followed up With a Cancer DiagnosisTurkey
-
Umm Al-Qura UniversityCompleted
-
Samsung Medical CenterRecruitingCritical IllnessKorea, Republic of
-
Foundation for Science, Health and Education, SpainHospital del Mar Research Institute (IMIM); La Caixa FoundationEnrolling by invitationHealth Behavior | Healthy Lifestyle | Heart Disease Risk FactorsSpain