Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000314527
Ethics application status
Approved
Date submitted
1/02/2024
Date registered
25/03/2024
Date last updated
14/07/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of iLidcombe - an online treatment for children who stutter.
Scientific title
Assessing safety and compliance of iLidcombe: an online program for children who stutter
Secondary ID [1] 309791 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stuttering. 330201 0
Condition category
Condition code
Physical Medicine / Rehabilitation 327072 327072 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Lidcombe program is a treatment for children who stutter and has clinical trials evidence (Brignell et al., 2020; Van Der Meulen & Pangalila, 2022). The Lidcombe Program is a behavioural treatment, administered by parents, under the guidance of a speech pathologist. For many children, treatment with the Lidcombe Program can resolve stuttering, and for others it can minimise stuttering significantly.

Researchers at the Australian Stuttering Research Centre have developed an online version of the Lidcombe Program —iLidcombe. iLidcombe is designed to replicate the clinical process of treatment with the Lidcombe Program. The aim of the iLidcombe is to teach parents how to implement the Lidcombe Program treatment with their child at home, without seeing a speech pathologist. iLidcombe has parent training modules that include instructional voice overs delivered by an experienced speech pathologist, video training materials which provide treatment demonstrations, text on pages and downloadable resources. The program teaches parents how to identify and measure stuttering. Parents then learn how to implement the treatment with their child.

iLidcombe has been designed to provide individualised feedback to parents based on the child’s progress during the treatment. Parents progress or unlock modules of the program based on their responses to questions throughout the program. The program provides an option for a parent to seek the services of a speech pathologist if they indicate in their responses that their child is not making progress, or the parent is having difficulty conducting the treatment.

iLidcombe has seventeen training modules which take between 4 and 6 hours to complete. The parent is not required to complete all the modules in one sitting. Following completion of the training parents begin administering the treatment to their child. This typically involves 15 – 20 minutes per day where the parent and child sit together doing the activities recommended by the program. Parents then log into the program weekly to enter information about their child's progress and to receive treatment recommendations.

The program is available to parents for a period of six months. They can log into the program any time that is convenient for them, but will be encouraged to log into the program regularly. The program has been designed for the parent and the child is not required to be present when the parent is engaging with the program.

The purpose of this research is to conduct a Phase 1 study to determine the safety of iLidcombe and to see if parents comply with the program requirements over a six-month period.

To assess safety, every week the parents will complete a 5-minute screening questionnaire, developed by researchers at the Australian Stuttering Research Centre. Based on the parent’s responses to this questionnaire, they may be asked to complete a standardised assessment, the Child Behavior Checklist (CBCL; Achenbach., 2011), that will take a minimum of 15 minutes up to a maximum of 60 minutes.

To assess compliance, data from the iLidcombe will be extracted. This data includes the dates that a parent logs into the program and the parent responses to questions such information about the child's stuttering. The data will be extracted six months post commencement of the treatment, to determine parent compliance with iLidcombe recommendations.
Intervention code [1] 326222 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334927 0
Number of participants who experience any adverse effect, such as a behavioural or emotional change.
This will be assessed using a screening questionnaire designed specifically for this study by the research team. The questionnaire will be administered weekly to the parents.
If a parent reports an emotional and behavioural change in their child, as indicted by their responses on the screening questionnaire, they will be requested to complete the Child Behavior Checklist (CBCL; Achenbach., 2011).
The Child Behavior Checklist will take between 15 and 60 minutes to complete. If a total raw score of >52 is recorded, indicating emotional and behavioural presentations that are outside the typical range, a one-hour interview will be conducted with the parent, speech pathologist and psychologist. This interview aims to determine if the changes in the child’s emotions and behaviour are attributed to the treatment or participation in the study and if this change warrants withdrawal from the program. An independent advisory team will be notified when a participant is withdrawn from the program to determine whether the trial is to be suspended or modified.
Timepoint [1] 334927 0
The weekly screening survey will be completed one week from commencement of the program, and then completed weekly for the six-month duration of access to the program.
Primary outcome [2] 334928 0
Parent compliance.
Compliance will be measured by data extracted from iLidcombe. The dates that parents log into iLidcombe are stored within the program, as are measures of treatment progress that the parent enters into the program during the course of treatment. This data will be extracted six months post commencement of the treatment. From the data participants will be classified into one of four categories: Compliant; completer; non-compliant; in-active.
A compliant participant will be classified as either 'Active' (i.e., has completed all the training modules and is administering treatment) or as a 'Completer' (i.e., the parent has completed all training modules and has finished administering the treatment to their child; and the child has no stuttering or very low levels of stuttering).
A non-compliant participant will be classified as either 'In-active' (i.e. the parent has not completed training within the set timeframe) or a 'Non-completer' (i.e. the parent has not entered enough measurement, or discontinued due to lack of improvement in the child’s stuttering severity ratings).
Timepoint [2] 334928 0
Six months post commencement of treatment.
Secondary outcome [1] 422475 0
Child stuttering severity, anxiety and avoidance in speaking situations.
This will be measured using Situations Avoidance, Anxiety and Stuttering Severity scale.
The Situations Avoidance, Anxiety and Stuttering Severity scale was developed by researchers at the Australian Stuttering Research Centre and has been used in previous research involving clinical trials and outcome studies.
Timepoint [1] 422475 0
Within one week prior to commencing treatment and six months post commencement.

Eligibility
Key inclusion criteria
• Child to be diagnosed with stuttering by a speech pathologist (case history + evidence of stuttering on parent-produced video recording).
• Minimum age of child to be 3 years, maximum age 7 years and 11 months
• Parent to have functional spoken and written English.
• Access to a stable internet connection.
• Located in Australia.
Minimum age
36 Months
Maximum age
95 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Child currently receiving treatment for stuttering.
• Child received Lidcombe Program treatment during the previous six months.
• Parent previously trained with Lidcombe Program procedures.
• No evidence of stuttering from a video recording.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/03/2024
Actual
18/04/2024
Date of last participant enrolment
Anticipated
5/02/2025
Actual
Date of last data collection
Anticipated
5/08/2025
Actual
Sample size
Target
20
Accrual to date
19
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313974 0
Government body
Name [1] 313974 0
National Health and Medical Research Council
Country [1] 313974 0
Australia
Primary sponsor type
University
Name
Australian Stuttering Research Centre, University of Technology Sydney
Address
University of Technology SydneyLevel 13, Building One15 BroadwayUltimo 2007
Country
Australia
Secondary sponsor category [1] 318144 0
None
Name [1] 318144 0
Address [1] 318144 0
Country [1] 318144 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313109 0
UTS Human Research Ethics Committee (HREC)
Ethics committee address [1] 313109 0
Ethics committee country [1] 313109 0
Australia
Date submitted for ethics approval [1] 313109 0
16/01/2023
Approval date [1] 313109 0
23/05/2023
Ethics approval number [1] 313109 0
ETH22-7825

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

Contacts
Principal investigator
Name 127034 0
Prof Mark Onslow
Address 127034 0
Australian Stuttering Research Centre, University of Technology Sydney, Level 13, Building One, 15 Broadway, Ultimo 2007
Country 127034 0
Australia
Phone 127034 0
+61 400001611
Fax 127034 0
Email 127034 0
[email protected]
Contact person for public queries
Name 127035 0
Mark Onslow
Address 127035 0
Australian Stuttering Research CentreUniversity of Technology SydneyLevel 13, Building One15 Broadway, Ultimo 2007
Country 127035 0
Australia
Phone 127035 0
+61 02 9514 5314
Fax 127035 0
Email 127035 0
[email protected]
Contact person for scientific queries
Name 127036 0
Robyn Lowe
Address 127036 0
Australian Stuttering Research Centre, University of Technology Sydney, Level 13, Building One, 15 Broadway, Ultimo 2007
Country 127036 0
Australia
Phone 127036 0
+61 02 9514 5314
Fax 127036 0
Email 127036 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
No individual participant data will be made available as ethical approval has not extended to this level of disclosure.


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.