Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000840583
Ethics application status
Approved
Date submitted
31/05/2024
Date registered
8/07/2024
Date last updated
8/07/2024
Date data sharing statement initially provided
8/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of iCamperdown - an online treatment for adults who stutter.
Scientific title
Assessing safety and compliance of iCamperdown: an online speech treatment for adults who stutter
Secondary ID [1] 312260 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stuttering. 333977 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330643 330643 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Camperdown program is a speech treatment for adults who stutter. The treatment is typically administered by a speech pathologist. Researchers at the Australian Stuttering Research Centre have developed an online version of the Camperdown Program —iCamperdown. iCamperdown is designed to replicate the procedures demonstrated in the 2024 guide of the Camperdown Program without needing a speech pathologist.

iCamperdown has incorporated audio recordings made by a speech pathologist who specialises in the treatment of stuttering. These audio recordings are available on every page of the program. The recordings provide important information to support the content on the pages such as detailed explanations, advice, and training for each step of the program. The program also provides video demonstrations of treatment procedures. iCamperdown has built in interactive tasks and activities for participants to develop independent problem-solving skills as per the aims of the traditional Camperdown Program. To assist learning and problem solving iCamperdown has incorporated six case studies that represent typical clients which illustrate different rates and styles of progress with the treatment. The program provides a set of downloadable resources that provide information and additional ideas to help participants complete the activities set by the program. The program also sends email reminders to participants to log in and continue their treatment.

iCamperdown has seven modules. The participants will not be required to complete all the modules in one sitting. A participant is able to work through the program in their own time and pace. Participants progress or unlock modules of the program as they progress and complete tasks.
Module One is an introduction, providing an overview of the program’s objectives and expectations. Participants complete pre-treatment questionnaires about their stuttering severity and satisfaction with their speech and ability to communicate.
In Module Two, participants learn the treatment agent, the Fluency Technique which is a different way of talking that can help to control stuttering. Initially the Fluency Technique will sound very unnatural and is not intended to be used in everyday speaking situations.
Modules Three and Four focuses on refining the speech technique. During these modules participants practice making their speech sound more natural while maintaining control of stuttering during different speaking tasks. During Module Four, participants work towards establishing a speech technique they feel is acceptable to use during daily conversations.
During Module Five participants learn to use their new speaking technique in everyday speaking situations by introducing slightly more challenging speaking tasks but still within the home environment and with known practice partners.
During Module Six participants start to use the technique in everyday conversations and they learn about factors that can affect the ability to use the new technique in daily situations with a focus on learning how to problem solve.
Module Seven addresses maintenance and relapse prevention, equipping participants with strategies to sustain treatment gains and navigate potential setbacks. This module concludes with post-treatment assessments, facilitating comparisons between pre- and post- treatment outcomes.
At the beginning of the program participants will engage with the program directly. However, as the participant progresses through the program, they will be encouraged to practice away from the program with a practice partner at least a few days each week.

The purpose of this study is to evaluate the safety and compliance with iCamperdown, and to establish preliminary treatment outcomes. Clinical experience and clinical trials evidence indicates that the program requirements can be completed within three to four months. For this study, participants will have access to the program for 4 months.

Safety will be measured as the proportion of participants who experience an adverse event that can be directly attributed to the program. Participants will complete the Patient Health Questionnaire-9 (PHQ-9) once a fortnight. A link to the questionnaire will be emailed directly to the participants. This questionnaire will take up to five minutes to complete. Adherence to completing this questionnaire will be monitored by the researchers. If participants fail to complete the questionnaire they will be sent a follow up email on day seven after the scheduled completion date. If the participant does not complete the second questionnaire, then the researcher will call the participant on day two after the scheduled completion date to complete the questionnaire over the phone. Any participant who does not respond to repeated follow up will be discussed on a case-by-case basis with the study investigators

To assess compliance with the treatment, data from the iCamperdown will be extracted at 5 months post commencement of treatment. This data includes dates the participant logs into the program and responses to the pre and post treatment questionnaires.

To assess preliminary treatment outcomes participants will complete questionnaires relating to stuttering and satisfaction with communication pre-treatment and post-treatment.

Intervention code [1] 328717 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338387 0
Number of participants who experience any adverse effect, such as a behavioural or emotional change.
Timepoint [1] 338387 0
The fortnightly screening survey will be administered two weeks after commencing participation in the study, and then administered fortnightly for the four-month duration of access to the program. The interview will not be assessed as an outcome, The interview will be arranged within 24 hours of receiving a questionnaire signaling an adverse event.
Primary outcome [2] 338388 0
Participant compliance.
Timepoint [2] 338388 0
Five months post commencement of treatment.
Secondary outcome [1] 435730 0
Preliminary treatment outcomes of iCamperdown.
Timepoint [1] 435730 0
Within one week prior to commencing treatment and five months post commencement of treatment.
Secondary outcome [2] 435731 0
Preliminary treatment outcomes of iCamperdown.
Timepoint [2] 435731 0
Within one week prior to commencing treatment and five months post commencement of treatment.

Eligibility
Key inclusion criteria
• Australian resident currently living in Australia
• Minimum age of 18
• No stuttering treatment with a speech pathologist during the preceding six months.
• Confirmation of stuttering by a speech pathologist during eligibility screening.
• Access to a stable internet connection.
• Functional spoken and written English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Adults who stutter who have completed user testing of iCamperdown within the last three months.
• Non-developmental origin of stuttering causality (e.g., neurogenic stuttering, drug-induced stuttering, psychogenic stuttering).
• Risk of self-harm pre-treatment as assessed by the Beck Depression Inventory, Question 9, score of 2 or higher. Such excluded participants will be referred for psychological care.
• Neurodevelopmental disorder including autism spectrum disorder, down syndrome, intellectual disability, and other genetic disorders affecting typical development and learning.

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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316645 0
Government body
Name [1] 316645 0
National Health and Medical Research Council
Country [1] 316645 0
Australia
Primary sponsor type
University
Name
Australian Stuttering Research Centre, University of Technology Sydney
Address
Country
Australia
Secondary sponsor category [1] 318829 0
None
Name [1] 318829 0
Address [1] 318829 0
Country [1] 318829 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315423 0
UTS Human Research Ethics Committee
Ethics committee address [1] 315423 0
Ethics committee country [1] 315423 0
Australia
Date submitted for ethics approval [1] 315423 0
07/09/2023
Approval date [1] 315423 0
18/01/2024
Ethics approval number [1] 315423 0
ETH23-8075

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

Contacts
Principal investigator
Name 134654 0
A/Prof Robyn Lowe
Address 134654 0
Australian Stuttering Research Centre, University of Technology Sydney, Level 13, Building One, 15 Broadway, Ultimo 2007
Country 134654 0
Australia
Phone 134654 0
+61 400001611
Fax 134654 0
Email 134654 0
[email protected]
Contact person for public queries
Name 134655 0
Robyn Lowe
Address 134655 0
Australian Stuttering Research Centre, University of Technology Sydney, Level 13, Building One, 15 Broadway, Ultimo 2007
Country 134655 0
Australia
Phone 134655 0
+61 400001611
Fax 134655 0
Email 134655 0
[email protected]
Contact person for scientific queries
Name 134656 0
Robyn Lowe
Address 134656 0
Australian Stuttering Research Centre, University of Technology Sydney, Level 13, Building One, 15 Broadway, Ultimo 2007
Country 134656 0
Australia
Phone 134656 0
+61 400001611
Fax 134656 0
Email 134656 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.