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Trial registered on ANZCTR


Registration number
ACTRN12624001133527
Ethics application status
Approved
Date submitted
4/09/2024
Date registered
19/09/2024
Date last updated
19/09/2024
Date data sharing statement initially provided
19/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating iBroadway: An online social anxiety treatment for adolescents who stutter.
Scientific title
Investigating the efficacy, safety and compliance of iBroadway: An online social anxiety treatment for adolescents who stutter.
Secondary ID [1] 312836 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stuttering 334955 0
Social Anxiety 334956 0
Condition category
Condition code
Mental Health 331486 331486 0 0
Anxiety
Physical Medicine / Rehabilitation 331606 331606 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised control trial reviewing the efficacy, client compliance and safety of a standalone, online treatment for adolescents who stutter known as iBroadway. The treatment provided by iBroadway is a modified version of iGlebe, a well-researched Cognitive Behavioural Treatment for adolescents who stutter developed by researchers at the Australian Stuttering Research Centre.

Participants will be randomised to one of two groups:
Experimental: Participants will gain access to the online cognitive behaviour treatment
(iBroadway)
Control / Waitlist Group: Participants will gain access to iBroadway after the 8month data
collection.

The online cognitive behaviour treatment program is known as iBroadway. The iBroadway program is designed to reduce or eliminate social anxiety in adolescents aged 11-17yrs who stutter. The treatment is completely online without any input from live clinicians.

iBroadway has seven modules. Participants complete the prescribed activities associated with each module before progressing to the next module. The first stage of the program involves developing an individualised profile for each participant. This is achieved by having the participant complete an online battery of assessments, The Unhelpful Thoughts and Beliefs About Stuttering: Adolescent scale (UTBAS-A), Avoidance of Speaking Situations questionnaire, Social Anxiety Scale for Adolescents (SAS:A), The Center for Epidemiological Studies-Depression (CES-D). These assessments are designed to comprehensively identify cognitive errors common to those who stutter, such as “people focus on every word I say,” “I won’t be able to keep a job if I stutter,” and “everyone in the room will hear me stutter.” The resultant profile is then used to design specific and individualised activities for each participant throughout the program. Instructions for each activity are given both in text on the screen and with pre-recorded spoken instructions from three different, highly specialised psychologists with extensive experience treating anxiety. Participants work through the activities at their own pace. Activities include behavioural experiments, cognitive restructuring, attention training, and writing tasks.

Participants have access to iBroadway for 5 months. Research has shown this to be adequate time to complete the program. Participants work at their own pace through each of the modules. The time spent working through each module can vary depending on participant responses to the initial questionnaires and the time they spend working on the activities and tasks. Participants can choose to repeat tasks as well. It is recommended that participants log into the program at least weekly. The teaching components for each module is expected to take between 1 and 2 hours depending on the module.

Once the participant completes the last module they can download a Superhero comic book / video summary of the program’s content.

The online treatment program is provided free of charge however the research project will not fund any costs associated with continuing any treatment at the conclusion of their participation. Adherence to iBroadway will be provided from data generated within the program and consists of dates of first login, date of login for each new module, date and page of last login.

To assess preliminary treatment outcomes participants will complete questionnaires relating to stuttering and satisfaction with communication pre-treatment and post-treatment.
Intervention code [1] 329382 0
Treatment: Other
Comparator / control treatment
The control condition is a waitlist.
An email will be sent to control group participants to advise of group allocation and access to the program will be granted after 8 months.
After the 8-month data point, waitlist control participants will be granted access to iBroadway.
Waitlist / control group participants are not permitted to access anxiety treatments during the waitlist control period.
Control group
Active

Outcomes
Primary outcome [1] 339230 0
Social Anxiety Scale of the Spence Children's Anxiety Scale
Timepoint [1] 339230 0
Pre-treatment
5 months post randomisation (primary timepoint).
8 months post randomisation.
Secondary outcome [1] 439178 0
Participant Safety
Timepoint [1] 439178 0
The weekly screening survey will be completed one week from commencement of the program, and then completed weekly for the five-month duration of access to the program.
Secondary outcome [2] 439308 0
Participant Compliance
Timepoint [2] 439308 0
Five months post randomisation for cohort who received iBroadway.
Secondary outcome [3] 439309 0
Avoidance Measure
Timepoint [3] 439309 0
- Pre-treatment
- 5 months post randomisation
- 8 months post randomisation
Secondary outcome [4] 439602 0
Anxiety Measure
Timepoint [4] 439602 0
- Pre-treatment
- 5 months post randomisation
- 8 months post randomisation
Secondary outcome [5] 439603 0
Stuttering Severity Measure
Timepoint [5] 439603 0
- Pre-treatment
- 5 months post randomisation
- 8 months post randomisation
Secondary outcome [6] 439604 0
Secondary Satisfaction Measure
Timepoint [6] 439604 0
- Pre-treatment
- 5 months post randomisation
- 8 months post randomisation
Secondary outcome [7] 439605 0
Satisfaction Measure
Timepoint [7] 439605 0
5 months post randomisation (post-treatment)
8 months post randomisation (post-treatment)

Eligibility
Key inclusion criteria
• Age 11 – 17 years
• Confirmation of stuttering by a speech pathologist during eligibility screening
• No psychological treatment for anxiety from a psychologist in the past 6 months.
• No psychological treatment using Cognitive Behavioural Treatment during the preceding six months.
• Australia or international resident
• Functional spoken and written English
• Access to a stable internet connection
• Currently receiving speech treatment OK but not a requirement.
Minimum age
11 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-developmental origin of stuttering causality (e.g., neurogenic stuttering, drug-induced stuttering, psychogenic stuttering).
• Neurodevelopmental disorder (e.g., diagnosis of developmental delay i.e., autism spectrum disorder, Down syndrome, intellectual disability, and other genetic disorders).
• Risk of self-harm as assessed by the CDI-II Short Form. Such excluded participants will be referred for psychological care.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who is "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analysis of covariance (ANCOVA) to compare groups at baseline, and 5 and 8 months follow up.
Medium effect size for anxiety measure to be clinically significant. (wouldn’t be able to power a small effect size).
Approximately 65 per group. To increase sample size due to potential loss to follow up. Base attrition rate based on Gunn et al.
To record if the participant was currently receiving speech treatment during the trial period.
Note for attrition Gunn et al. 2019:
29 assessed – 2 excluded, 3 no log in, 2 did not complete pre-treatment assessments.
Therefore 22 participants and 21 with post treatment data. That is 5%.
For a 10% attrition rate – 72 per group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2024
Actual
Date of last participant enrolment
Anticipated
1/01/2025
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26537 0
New Zealand
State/province [1] 26537 0

Funding & Sponsors
Funding source category [1] 317276 0
Government body
Name [1] 317276 0
National Health and Medical Research Council
Country [1] 317276 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Country
Australia
Secondary sponsor category [1] 319595 0
None
Name [1] 319595 0
Address [1] 319595 0
Country [1] 319595 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316014 0
UTS Human Research Ethics Committee
Ethics committee address [1] 316014 0
Ethics committee country [1] 316014 0
Australia
Date submitted for ethics approval [1] 316014 0
09/04/2024
Approval date [1] 316014 0
31/07/2024
Ethics approval number [1] 316014 0
UTS HREC REF NO. ETH24-9346

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

Contacts
Principal investigator
Name 136506 0
Prof Ross Menzies
Address 136506 0
Australian Stuttering Research Centre University of Technology Sydney Level 13, Building One, 15 Broadway, Ultimo NSW 2007
Country 136506 0
Australia
Phone 136506 0
+61 433 163 217
Fax 136506 0
Email 136506 0
[email protected]
Contact person for public queries
Name 136507 0
Laura Crewdson
Address 136507 0
Australian Stuttering Research Centre University of Technology Sydney Level 13, Building One, 15 Broadway, Ultimo NSW 2007
Country 136507 0
Australia
Phone 136507 0
+61 02 9514 5314
Fax 136507 0
Email 136507 0
[email protected]
Contact person for scientific queries
Name 136508 0
Ross Menzies
Address 136508 0
Australian Stuttering Research Centre University of Technology Sydney Level 13, Building One, 15 Broadway, Ultimo NSW 2007
Country 136508 0
Australia
Phone 136508 0
+61 02 9514 5314
Fax 136508 0
Email 136508 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


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.