Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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.
Query!
Scientific title
Investigating the efficacy, safety and compliance of iBroadway: An online social anxiety treatment for adolescents who stutter.
Query!
Secondary ID [1]
312836
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Stuttering
334955
0
Query!
Social Anxiety
334956
0
Query!
Condition category
Condition code
Mental Health
331486
331486
0
0
Query!
Anxiety
Query!
Physical Medicine / Rehabilitation
331606
331606
0
0
Query!
Speech therapy
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
329382
0
Treatment: Other
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
339230
0
Social Anxiety Scale of the Spence Children's Anxiety Scale
Query!
Assessment method [1]
339230
0
In order to determine if iBroadway is better than a waitlist at reducing social anxiety with adolescents who stutter, the Spence Children's Anxiety Scale will be administered to all participants. Social anxiety levels will be compared between the control and experimental cohort to determine the effectiveness of iBroadway in reducing social anxiety compared to a waitlist.
Query!
Timepoint [1]
339230
0
Pre-treatment
5 months post randomisation (primary timepoint).
8 months post randomisation.
Query!
Secondary outcome [1]
439178
0
Participant Safety
Query!
Assessment method [1]
439178
0
Participants will complete the Depression Anxiety Stress Scale – Youth Version (DASS-Y) weekly.
Safety will be measured as the proportion of participants who experience an adverse event that can be directly attributed to the program. An adverse event is defined as any of the following:
1) a significant worsening in depression scores on the DASS-Y. This includes a participant’s scores increasing 5 points and moving to severe or extremely severe levels.
If a safety concern is indicated, then:
• An interview will be conducted with the adolescent who stutters, the parent, and one of the investigators and a psychologist from the research team.
• The interviewers will decide if the change is linked to the treatment.
• If the interviewers decide the change is linked to the treatment, then participant is asked to withdraw from the treatment, they will be blocked out of program and provided with an appropriate referral to a psychologist or speech pathologist.
• An independent advisory team will be notified when a participant is withdrawn from the program to determine whether the trial needs to be completely suspended.
If the participant fails to complete the DASS-Y the following protocol will occur:
• Qualtrics will send a follow up email on day 7 after the scheduled completion date, to remind any participant who has not completed the weekly DASS-Y to do so.
• Qualtrics will send an alert to the researcher if a participant fails to complete the weekly survey on two consecutive weeks.
• If the participant does not complete the second DASS-Y then the researcher will call the participant on day 2 after the scheduled completion date and complete the DASS-Y on the phone.
• Any participant that does not respond to repeated follow up will be discussed on a case by case basis. Their data will still be used for compliance analysis.
Query!
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.
Query!
Secondary outcome [2]
439308
0
Participant Compliance
Query!
Assessment method [2]
439308
0
Participant status (completer or non-completer) at five months post randomisation.
1) Completer - Completed all modules of the program.
2) Non-completer – Did not complete all modules of the program. Number of modules completed will be documented.
• Built into iBroadway are timestamps to determine whether the participant has completed all training requirements within a specified amount of time.
• The program will automatically classify all participants into one of the above two categories.
Query!
Timepoint [2]
439308
0
Five months post randomisation for cohort who received iBroadway.
Query!
Secondary outcome [3]
439309
0
Avoidance Measure
Query!
Assessment method [3]
439309
0
The following assessment will be administered to determine if iBroadway better than a waitlist in improving avoidance outcomes:
- Adolescent self-report Situation Avoidance, Anxiety and Stuttering Severity Questionnaire (SAASS)
• Self-reported avoidance across eight situations
Query!
Timepoint [3]
439309
0
- Pre-treatment
- 5 months post randomisation
- 8 months post randomisation
Query!
Secondary outcome [4]
439602
0
Anxiety Measure
Query!
Assessment method [4]
439602
0
The following assessment will be administered to determine if iBroadway better than a waitlist in improving anxiety outcomes:
- Adolescent self-report Situation Avoidance, Anxiety and Stuttering Severity Questionnaire (SAASS)
• Self-reported anxiety across eight situations
Query!
Timepoint [4]
439602
0
- Pre-treatment
- 5 months post randomisation
- 8 months post randomisation
Query!
Secondary outcome [5]
439603
0
Stuttering Severity Measure
Query!
Assessment method [5]
439603
0
The following assessment will be administered to determine if iBroadway better than a waitlist in improving stuttering severity outcomes:
- Adolescent self-report Situation Avoidance, Anxiety and Stuttering Severity Questionnaire (SAASS)
• Typical & most severe self-reported stuttering severity across eight situations
Query!
Timepoint [5]
439603
0
- Pre-treatment
- 5 months post randomisation
- 8 months post randomisation
Query!
Secondary outcome [6]
439604
0
Secondary Satisfaction Measure
Query!
Assessment method [6]
439604
0
The following assessment will be administered to determine if iBroadway better than a waitlist in improving satisfaction outcomes:
- Satisfaction with Communication in Everyday Speaking Situations (SCESS)
Query!
Timepoint [6]
439604
0
- Pre-treatment
- 5 months post randomisation
- 8 months post randomisation
Query!
Secondary outcome [7]
439605
0
Satisfaction Measure
Query!
Assessment method [7]
439605
0
The following assessment will be administered to determine if iBroadway better than a waitlist in improving satisfaction outcomes:
- Seeking Professional Support Post Therapy Questionnaire
Query!
Timepoint [7]
439605
0
5 months post randomisation (post-treatment)
8 months post randomisation (post-treatment)
Query!
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.
Query!
Minimum age
11
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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".
Query!
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).
Query!
Masking / blinding
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
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.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
30/09/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
1/01/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
31/01/2026
Query!
Actual
Query!
Sample size
Target
144
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Query!
Recruitment outside Australia
Country [1]
26537
0
New Zealand
Query!
State/province [1]
26537
0
Query!
Funding & Sponsors
Funding source category [1]
317276
0
Government body
Query!
Name [1]
317276
0
National Health and Medical Research Council
Query!
Address [1]
317276
0
Query!
Country [1]
317276
0
Australia
Query!
Primary sponsor type
University
Query!
Name
University of Technology Sydney
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
319595
0
None
Query!
Name [1]
319595
0
Query!
Address [1]
319595
0
Query!
Country [1]
319595
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
316014
0
UTS Human Research Ethics Committee
Query!
Ethics committee address [1]
316014
0
https://www.uts.edu.au/research-and-teaching/research/our-approach/ethics-and-integrity/human-research-ethics
Query!
Ethics committee country [1]
316014
0
Australia
Query!
Date submitted for ethics approval [1]
316014
0
09/04/2024
Query!
Approval date [1]
316014
0
31/07/2024
Query!
Ethics approval number [1]
316014
0
UTS HREC REF NO. ETH24-9346
Query!
Summary
Brief summary
Researchers at the Australian Stuttering Research Centre have developed an online anxiety treatment program—iBroadway—for adolescents who stutter. The purpose of this research is to assess the effectiveness and safety of the iBroadway Program as well as evaluate compliance rates. The iBroadway Program has the potential to overcome problems of access to treatment for many adolescents who stutter.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
136506
0
Prof Ross Menzies
Query!
Address
136506
0
Australian Stuttering Research Centre University of Technology Sydney Level 13, Building One, 15 Broadway, Ultimo NSW 2007
Query!
Country
136506
0
Australia
Query!
Phone
136506
0
+61 433 163 217
Query!
Fax
136506
0
Query!
Email
136506
0
[email protected]
Query!
Contact person for public queries
Name
136507
0
Laura Crewdson
Query!
Address
136507
0
Australian Stuttering Research Centre University of Technology Sydney Level 13, Building One, 15 Broadway, Ultimo NSW 2007
Query!
Country
136507
0
Australia
Query!
Phone
136507
0
+61 02 9514 5314
Query!
Fax
136507
0
Query!
Email
136507
0
[email protected]
Query!
Contact person for scientific queries
Name
136508
0
Ross Menzies
Query!
Address
136508
0
Australian Stuttering Research Centre University of Technology Sydney Level 13, Building One, 15 Broadway, Ultimo NSW 2007
Query!
Country
136508
0
Australia
Query!
Phone
136508
0
+61 02 9514 5314
Query!
Fax
136508
0
Query!
Email
136508
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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.
Download to PDF