Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000348853
Ethics application status
Approved
Date submitted
26/03/2012
Date registered
26/03/2012
Date last updated
26/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Stuttering and speech sound disorders: a phase I clinical trial using the Lidcombe Program
Scientific title
Can stuttering and speech sound disorders that present concomitantly in preschool aged children be treated concurrently and effectively using the Lidcombe Program and individualized speech sound disorder therapy?
Secondary ID [1] 280216 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stuttering (disfluency) 286152 0
Speech sound disorders 286153 0
Condition category
Condition code
Other 286349 286349 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Other 286359 286359 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dual delivery of the Lidcombe Program for stuttering and also individualized speech sound disorder based on interventions that are evidence-based for this caseload. The Lidcombe Program is delivered in 2 stages, with stage 1 considered the active treatment stage and stage 2 being the maintenance/monitoring stage. Currently approximately 90% of children complete stage 1 of the Lidcombe Program in around 20 weeks, although this is for children who stutter in isolation. It is not known how long children with concomitant speech sound disorder will take to respond to the Lidcombe Program. Similarly, there are many evidence-based forms of speech sound disorder intervention types. During this trial, the intervention chosen will be based on the individual child's goals and needs, in line with surrounding evidence. As such it is impossible to predict treatment time in this instance.
Much of the research looks at treating these two co-occurring disorders in isolation. This experimental phase I trial aims to look at whether the two disorders can be treated at the same time, using evidence-based approaches to therapy. The research team will treat participants for up to 9 months if required. If participants have not reached the end of stage 1 of the Lidcombe Program by 22 weeks, treatment will revert to delivering the Lidcombe Program alone, as is standard protocol. If after 9 months, participants require ongoing intervention (i.e. stage 2 of the Lidcombe Program or treatment for residual speech sound error), referrals will be made for participants to access this treatment via the appropriate service provider(s).
Intervention code [1] 284545 0
Treatment: Other
Comparator / control treatment
There is no control treatment being used in this trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286811 0
Primary outcome for the stuttering will be percentage of syllables stuttered (%SS), based on 10 minute parent conducted audio recordings made away from the clinic. Two recordings would be conducted: one with the child speaking to a household resident, and the other speaking to a non-household resident, although this person must be familiar to the child (all assessment occasions noted below). Percentage of syllables stuttered will also be gained within the clinic (at all assessment occasions noted below).
Timepoint [1] 286811 0
1. At entry into research program
2. At entry into stage 2 of Lidcombe Program
3. Nine months post entry into the study
4. Twelve months post entry into the study
5. Eighteen months post entry into the study
Primary outcome [2] 286812 0
Primary outcome measure for the speech sound disorder will be measured by percentage of consonants correct (PCC), based on conversational speech sample. Samples will be gathered within the clinic from interaction between either parent and child or researching clinician and child (at all assessment occasions noted below). Percentage of consonants correct within a single word naming test, one sub-test from the Diagnostic Evaluation of Articulation and Phonology (DEAP) (at all assessment occasions noted below).
Timepoint [2] 286812 0
1. At entry into research program
2. At entry into stage 2 of Lidcombe Program
3. Nine months post entry into the study
4. Twelve months post entry into the study
5. Eighteen months post entry into the study
Secondary outcome [1] 296717 0
Nil
Timepoint [1] 296717 0
Nil

Eligibility
Key inclusion criteria
Diagnosis of stuttering obtained by consensus between 2 speech pathologists or between 1 speech pathologist and caregiver
Diagnosis of speech sound disorder determined by the presence of either a) two or more age-inappropriate phonological processes or; b) one atypical phonological process
Participants and caregivers will have a functional command and understanding of the English language
Hearing levels reported within normal limits
Pass a receptive and expressive language screener. If screener not passed, then receptive and expressive language abilities rated at no greater than mildly delayed on subsequently administered standardised assessment
Oral motor structure and function must be measured and assessed as being within normal limits
Speech sound errors must be phonological in nature (i.e. not suspected childhood apraxia of speech, lateral lisps etc. therefore child must be stimulable in at least 1 context for the sounds in error)
Stuttering onset reportedly at least six months prior to recruitment
Minimum age
42 Months
Maximum age
72 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Excluded if child has received treatment for either the stuttering or the speech sound disorder within 12 months prior to recruitment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a non-controlled trial, therefore all participants wishing to enroll will be delivered the same treatment protocol.
Procedures for enrolling are:
The information statements will be distributed to the treating clinicians at the University of Newcastle’s Stuttering Clinic, who are not part of this research project. These clinicians will pass on the information statement and consent forms to interested participants, conforming to NS3.3.17 (National Statement on Ethical Conduct in Human Research, 2007) (where the researcher is the treating clinician, consent from participants sought by person independent to the research). Participants may be drawn from current presenting clients or from the current clinical waiting list.
Clinical staff will invite potential interested participants to contact the research team if they have queries about the project. If willing to consent, participants will give signed consent forms back to treating clinicians who will then pass these on to the research team.
Once consent forms are received, the student researcher will contact the family to arrange a suitable time to engage participants in conversation about the research procedures and gain verbal assent from child (if appropriate). An initial battery of assessments will be conducted at this time to ascertain eligibility criteria. If potential participants meet these criteria, they will be advised of this and may commence the therapy protocol as soon as convenient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284966 0
University
Name [1] 284966 0
University of Newcastle
Country [1] 284966 0
Australia
Primary sponsor type
Individual
Name
Dr Sally Hewat
Address
Faculty of Education and Arts
SHSS, McMullin Building
The University of Newcastle
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 283834 0
None
Name [1] 283834 0
Address [1] 283834 0
Country [1] 283834 0
Other collaborator category [1] 260655 0
Individual
Name [1] 260655 0
Dr Elizabeth Spencer (co-supervisor)
Address [1] 260655 0
Faculty of Education and Arts
SHSS, McMullin Building
The University of Newcastle
Callaghan NSW 2308
Country [1] 260655 0
Australia
Other collaborator category [2] 260656 0
Individual
Name [2] 260656 0
Dr Elisabeth Harrison (co-supervisor)
Address [2] 260656 0
Senior Lecturer & Program Convenor
Master of Speech & Language Pathology
Department of Linguistics
MACQUARIE UNIVERSITY NSW 2109
Country [2] 260656 0
Australia
Other collaborator category [3] 260657 0
Individual
Name [3] 260657 0
Rachael Unicomb (student researcher)
Address [3] 260657 0
Faculty of Education and Arts
SHSS, McMullin Building
The University of Newcastle
Callaghan NSW 2308
Country [3] 260657 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286973 0
University of Newcastle - Human Research Ethics Committee
Ethics committee address [1] 286973 0
Research Services
Research Integrity Unit
HA148, Hunter Building
The University of Newcastle
CALLAGHAN NSW 2308
Ethics committee country [1] 286973 0
Australia
Date submitted for ethics approval [1] 286973 0
Approval date [1] 286973 0
22/03/2012
Ethics approval number [1] 286973 0
H-2011-0383

Summary
Brief summary
The aim of this clinical trial is to establish whether stuttering and speech sound disorder can be treated simultaneously. It is estimated that between 30-40% of children who stutter also have a speech sound disorder. Both disorders are known to have effects that may continue into the child's school years and beyond if not treated early. Currently there are a number of effective interventions that aim to treat fluency and speech sound disorders when they present in isolation. A small number of participants will be recruited to carry out a combined stuttering/speech sound disorder treatment program to establish safety and correct clinical protocols.
Trial website
None
Trial related presentations / publications
Speech Pathology Australia conference, June 2012 (Hobart)
Public notes

Contacts
Principal investigator
Name 33975 0
Address 33975 0
Country 33975 0
Phone 33975 0
Fax 33975 0
Email 33975 0
Contact person for public queries
Name 17222 0
Dr Sally Hewat
Address 17222 0
Faculty of Education and Arts
SHSS, McMullin Building
University of Newcastle
Callaghan NSW 2308
Country 17222 0
Australia
Phone 17222 0
+61 2 4921 5159
Fax 17222 0
Email 17222 0
[email protected]
Contact person for scientific queries
Name 8150 0
Dr Sally Hewat
Address 8150 0
Faculty of Education and Arts
SHSS, McMullin Building
University of Newcastle
Callaghan NSW 2308
Country 8150 0
Australia
Phone 8150 0
+61 2 4921 5159
Fax 8150 0
Email 8150 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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