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StutteringPhase 2NCT00680303

Spacing Lidcombe Program Clinic Visits

A Phase 2 study testing The Lidcombe Program for early stuttering in people with Stuttering, run by University of Sydney at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Stuttering
What is being tested?
The Lidcombe Program for early stuttering
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesin 2 countries
Study dates
Jan 2008to Dec 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

Mark Onslow contact

M.Onslow@usyd.edu.au

Sally Hewat contact

Sally.Hewat@newcastle.edu.au

2 sites in 2 countries

Australia1 site, 1 recruiting
  • University of Newcastle

    Newcastle, New South Wales, 2308

    Sally Hewat, 61-2-4921 5159, Sally.Hewat@newcastle.edu.au

    Sarita Koushik, 61-2-4921-6414, Sarita.Koushik@studentmail.newcastle.edu.au

    Recruiting

Other trials in Australia

Canada1 site, 1 recruiting
  • The Montreal Fluency Centre

    Montreal, Quebec

    Rosalee Shenker, 514-489-4320, Rosalee@montrealfluency.com

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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?

Conditions
Stuttering
Being tested
The Lidcombe Program for early stuttering
Keywords
Early Stuttering, Lidcombe Program, Stuttering Treatment, Efficiency, Efficacy, Service Delivery, Models of intervention
Medical subject headings
Stuttering

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Lidcombe Program for early stutteringBehavioural

  • The Lidcombe Program for early stutteringBehavioural

  • The Lidcombe Program for early stutteringBehavioural

Study groups in NCT00680303
Study groupRoleWhat they receive
1ExperimentalThe child will receive the Lidcombe Program 2x per week
Receives: Behavioral: The Lidcombe Program for early stuttering
2ExperimentalThe child will receive the Lidcombe Program once every 2 weeks (fortnightly visits)
Receives: Behavioral: The Lidcombe Program for early stuttering
3OtherThe child will receive the standard Lidcombe Program once per week (control)
Receives: Behavioral: The Lidcombe Program for early stuttering

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Entry into Stage II

Secondary outcomes (1)
  1. Parent reported Severity Ratings (SR)

    Measured: Pre-treatment, entry into Stage 2, 9 months post-randomization, 18 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2009 (estimated)
  4. Study completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00680303
Sponsor's protocol ID
402763-17
Other IDs
402763
Status last verified
Apr 2008
First submitted
15 May 2008
Last updated
20 May 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing The Lidcombe Program for early stuttering in people with Stuttering, run by University of Sydney at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mark Onslow (M.Onslow@usyd.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2008.

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