Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000792921
Ethics application status
Approved
Date submitted
14/02/2020
Date registered
6/08/2020
Date last updated
6/08/2020
Date data sharing statement initially provided
6/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes from the implementation of a telepractice delivered Lidcombe Program service for primary school aged children who stutter.
Scientific title
Outcomes from the implementation of a telepractice delivered Lidcombe Program service for primary school aged children who stutter.
Secondary ID [1] 300558 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stuttering 316280 0
Condition category
Condition code
Neurological 315979 315979 0 0
Other neurological disorders
Public Health 316511 316511 0 0
Health service research
Physical Medicine / Rehabilitation 316512 316512 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Lidcombe Program is a behavioural treatment approach in which parents are trained to implement treatment in the child’s natural environment. Parents are taught in weekly 45-60 minute sessions with a speech pathologist to provide verbal contingencies for stutter-free and stuttered speech in both controlled and naturalistic settings. Treatment is delivered in two stages. In Stage 1 the child (and parent) attends weekly sessions with the speech pathologist and receives daily parent-administered treatment until there is no stuttering (or almost no stuttering) when they speak. The daily treatment involves 15 minutes of speech activities during which the parent will provide the contingencies taught by the speech pathologist.
In Stage 2, treatment is gradually withdrawn over an extended period in a formalised way. Children and their parent attend sessions with their speech pathologist with the following gaps between sessions 2 weeks, 2 weeks, 4 weeks, 4 weeks, 8 weeks, 8 weeks, 16 weeks, 16 weeks.

In this clinical trial participants will receive treatment using telepractice (i.e. a secure video-conferencing platform). During the weekly 45-60 minute treatment sessions participants will be situated in their school with a parent also in attendance. The treating speech pathologist will connect remotely via video conference and will be located in their office. In this trial, post-treatment outcome measures (final data point) will be taken 9 months after commencing treatment irrespective of what stage of the Lidcombe Program the child has reached. The participants will continue to receive treatment from their treating speech pathologist until completion of Stage 2 of the program. Research has shown that 90% of children complete Stage 1 within 28 weeks (i.e. approximately 7 months).
Intervention code [1] 316856 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322879 0
Percentage of syllables stuttered from a 10 minute speech sample
Timepoint [1] 322879 0
Pre-treatment and 9 months after commencing treatment
Secondary outcome [1] 380121 0
Severity rating (0-9) for a 10 minute speech sample
Timepoint [1] 380121 0
Pre-treatment and 9 months post commencing treatment
Secondary outcome [2] 380122 0
The duration of treatment will be measured by the speech pathologist who will keep file notes for each session. This will allow for calculation of the both the number of sessions and the total number of weeks the child received treatment.
Timepoint [2] 380122 0
Post-treatment
Secondary outcome [3] 380123 0
Parents will complete a questionnaire devised for the purposes of this research called the 'Telepractice Lidcombe Program Parent Questionnaire'. This questionnaire asks parents to respond to 12 questions using a 5-point Likert scale (Totally agree to Totally disagree). The questions relate to aspects of treatment related to 'rapport', 'training', 'attendance', and 'technology'.
Timepoint [3] 380123 0
Post-treatment

Eligibility
Key inclusion criteria
Participants will be children who stutter (and a parent/caregiver), attending primary schools within the Catholic Education Melbourne networks. The inclusion criteria at assessment are: (a) the child is not older than 10 years; (b) the parent and child have functional English; (c) a consensus diagnosis of stuttering by both the parent and speech pathologist; (d) parent and child available to engage in weekly, school-based 60-minute treatment sessions for at least 9 months; (e) willing to commit to the Lidcombe Program treatment requirements; and (f) have access to a suitable treatment space and computer with adequate internet connectivity at their school. Children with significant concomitant disorders that prohibit engagement in this treatment model will be reviewed by the chief investigators on a case-by-case basis.
Minimum age
5 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data collected within this project will be quantitative, including measures of stuttering (% of syllables stuttered and severity ratings), treatment efficiency (number of treatment sessions and total number of weeks in treatment) and parent surveys (satisfaction and attitudes towards treatment). This data will be described descriptively using measures of central tendency (i.e. mean or median where relevant) and measures of variability (range and standard deviation). Group mean comparisons (i.e. of speech measures at each data point) will be analysed using an appropriate statistic depending on the meeting of data assumptions. Assuming normal distribution of data, comparisons of two samples will be completed with paired samples t-tests and analyses with more than two samples will be completed with ANOVA. Correlation analyses (intraclass correlations) will be completed to assess interjudge and intrajudge reliability rates from 10% of the speech recordings.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2020
Actual
Date of last participant enrolment
Anticipated
12/04/2021
Actual
Date of last data collection
Anticipated
13/01/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304968 0
Commercial sector/Industry
Name [1] 304968 0
Speech Pathology Australia
Country [1] 304968 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive, Bundoora, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 305327 0
Commercial sector/Industry
Name [1] 305327 0
Catholic Education Melbourne
Address [1] 305327 0
James Goold House, 228 Victoria Parade, East Melbourne, Victoria, 3002
Country [1] 305327 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305379 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 305379 0
Ethics committee country [1] 305379 0
Australia
Date submitted for ethics approval [1] 305379 0
24/02/2020
Approval date [1] 305379 0
01/05/2020
Ethics approval number [1] 305379 0
HEC20090
Ethics committee name [2] 306239 0
Catholic Education Melbourne
Ethics committee address [2] 306239 0
Ethics committee country [2] 306239 0
Australia
Date submitted for ethics approval [2] 306239 0
06/05/2020
Approval date [2] 306239 0
26/05/2020
Ethics approval number [2] 306239 0
1006

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100178 0
Dr Shane Erickson
Address 100178 0
Discipline of Speech Pathology, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086
Country 100178 0
Australia
Phone 100178 0
+61 03 9479 1838
Fax 100178 0
Email 100178 0
[email protected]
Contact person for public queries
Name 100179 0
Shane Erickson
Address 100179 0
Discipline of Speech Pathology, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086
Country 100179 0
Australia
Phone 100179 0
+61 03 9479 1838
Fax 100179 0
Email 100179 0
[email protected]
Contact person for scientific queries
Name 100180 0
Shane Erickson
Address 100180 0
Discipline of Speech Pathology, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086
Country 100180 0
Australia
Phone 100180 0
+61 03 9479 1838
Fax 100180 0
Email 100180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We see no reason to share this sensitive client data publicly.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.