Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001270606
Ethics application status
Approved
Date submitted
30/10/2023
Date registered
6/12/2023
Date last updated
29/02/2024
Date data sharing statement initially provided
6/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The experience of adults and teens who stutter undertaking group improv therapy
Scientific title
Psychosocial outcomes of adults and teens who stutter undertaking group improv therapy
Secondary ID [1] 310839 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stuttering 331846 0
Social Anxiety 331847 0
Condition category
Condition code
Mental Health 328591 328591 0 0
Anxiety
Neurological 328592 328592 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will take part in one block of ‘Swift Group Improv Therapy’. The block consists of one 60-minute session per week over a 9-week period requiring at minimum 9 individual visits to clinic.
Therapy has elements of traditional advanced stuttering approaches (stuttering modification), but is combined with a contemporary psychological initiative, Acceptance and Commitment Therapy. Group improv (pre set games) is used as the vehicle that delivers these elements. The games allow for the opportunity to examine attitudes and feelings around a variety of communication situations, allowing participants to identify individual strengths and challenges.
The pre-set improv games increase in complexity over the course of the treatment. Initially, simple games that are predominantly non-verbal are used, followed by troupe/team work drama games and finally "Offer and acceptance" games.
The groups will contain 6-10 participants aged either 14-17 years old or 18+ years old. The intervention will be delivered by a speech pathologist with improv experience and an improv teacher over the 9 weeks.
A treatment manual will be used by the treating speech pathologist. A case file audit of the session notes associated with the group sessions will be conducted to monitor adherence to the intervention.
Intervention code [1] 327260 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336409 0
Stuttering Impact
Timepoint [1] 336409 0
Pre-treatment (baseline)
Immediately post-treatment - that is within 1 week of the final group session (primary timepoint)
6 months post-completion of the treatment program
Primary outcome [2] 336433 0
Changes in thoughts about stuttering
Timepoint [2] 336433 0
Pre-treatment (baseline)
Immediately post-treatment - that is within 1 week of the final group session (primary timepoint)
6 months post-completion of the treatment program
Primary outcome [3] 336434 0
Participant perceived contexts, mechanisms and outcomes and changes in communicative self-efficacy
Timepoint [3] 336434 0
1 to 3 months post-completion of the treatment program
Secondary outcome [1] 428361 0
Stuttering Severity
Timepoint [1] 428361 0
Pre-treatment (baseline)
Immediately post-treatment - that is within 1 week of the final group session
6 months post-completion of the treatment program
Secondary outcome [2] 428362 0
Social phobia screen
Timepoint [2] 428362 0
Pre-treatment (baseline)
Immediately post-treatment - that is within 1 week of the final group session
6 months post-completion of the treatment program
Secondary outcome [3] 428363 0
Stuttering frequency
Timepoint [3] 428363 0
Pre-treatment (baseline)
Immediately post-treatment - that is within 1 week of the final group session
6 months post-completion of the treatment program
Secondary outcome [4] 428365 0
Change in fear of negative evaluation
Timepoint [4] 428365 0
Pre-treatment (baseline)
Immediately post-treatment - that is within 1 week of the final group session
6 months post-completion of the treatment program
Secondary outcome [5] 428366 0
Readiness for Change
Timepoint [5] 428366 0
Pre-treatment (baseline)
Immediately post-treatment - that is within 1 week of the final group session
6 months post-completion of the treatment program

Eligibility
Key inclusion criteria
Ages: 14 years and over
Gender: No restriction.
Diagnostic Status: Must have been reportedly stuttering >6 months and possess a stuttering diagnosis. If potential participant does not have a
stuttering diagnosis, an appointment with qualified clinician will be arranged to undertake assessment.
Stuttering Severity: There is no minimum severity level (as per Overall Assessment of Speaker's Experience - OASES or overt stuttering) required for participation.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must be able to speak sufficient English without use of an interpreter that enables full participation in therapy. This will be
determined by the researcher during screening call.
Participants will be excluded if they will be concurrently accessing other speech therapy services.
Participants with an existing diagnosis of psychogenic or neurogenic stuttering will be excluded from participation.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Transcription: Audio files transcribed into verbatim written records. These are logged, dated and stored as well as the original audio files.
Initial (open) Coding: Inductively generate as many codes as possible while breaking up the initial data and assessing for patterns as well as code comparators. Begin to categorise and allot meaning to data. Assessing for relevance to topic and goals of research.
Initiate memoing and indexing: Document ongoing analytical insights that expound upon the codes and decision making processes. Indexing illustrates diversity of codes and is useful in rigour.
Identify Themes in Codes: Analyse codes for themes including superordinate themes, subthemes and subdivisions of themes that concentrate on significant and relevant
components and contribute to informing study question(s).
Review themes: Review, modify and develop the preliminary themes that have been identified. Gather transcript data relevant to each theme.
Appraise themes for coherency and their distinction from one another. Making sure data supports the themes. Identify additional themes including subthemes within preliminary themes.
Define themes: Identify the nature each theme. Identify how the themes relate to one another, how the subthemes relate to main theme(s).
Explore what the theme(s) are saying. Researcher interpretation. Construct a thematic map (diagram).
Use the qualitative and quantitative data to form CMO configurations to document contexts (C) and mechanisms (M) leading to favourable and less favourable outcomes (O).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/03/2024
Actual
Date of last participant enrolment
Anticipated
25/03/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
20
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315083 0
University
Name [1] 315083 0
University of South Australia
Country [1] 315083 0
Australia
Funding source category [2] 315099 0
Commercial sector/Industry
Name [2] 315099 0
Swift Speech, Stuttering & Voice
Country [2] 315099 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 317104 0
Commercial sector/Industry
Name [1] 317104 0
Swift Speech, Stuttering & Voice
Address [1] 317104 0
PO Box 104, Highgate SA 5063
Country [1] 317104 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314031 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 314031 0
Ethics committee country [1] 314031 0
Australia
Date submitted for ethics approval [1] 314031 0
27/10/2023
Approval date [1] 314031 0
20/12/2023
Ethics approval number [1] 314031 0
205793

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

Contacts
Principal investigator
Name 130182 0
Dr Michelle Swift
Address 130182 0
Allied Health & Human Performance, UniSA, GPO Box 2471, Adelaide SA 5001
Country 130182 0
Australia
Phone 130182 0
+61 8 8302 7782
Fax 130182 0
Email 130182 0
michelle.swift@unisa.edu.au
Contact person for public queries
Name 130183 0
Michelle Swift
Address 130183 0
Allied Health & Human Performance, UniSA, GPO Box 2471, Adelaide SA 5001
Country 130183 0
Australia
Phone 130183 0
+61 8 8302 7782
Fax 130183 0
Email 130183 0
michelle.swift@unisa.edu.au
Contact person for scientific queries
Name 130184 0
Michelle Swift
Address 130184 0
Allied Health & Human Performance, UniSA, GPO Box 2471, Adelaide SA 5001
Country 130184 0
Australia
Phone 130184 0
+61 8 8302 7782
Fax 130184 0
Email 130184 0
michelle.swift@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For clients who consent, all of the participant data collected during the trial will be uploaded to the FluencyBank database
When will data be available (start and end dates)?
From immediately post-publication, no end date
Available to whom?
Researchers with a methodologically sound research proposal will need to approach the TalkBank data registry (which hosts the FluencyBank database) in order to access the data
Available for what types of analyses?
Any analysis that is approved by the TalkBank registry
How or where can data be obtained?
Researchers with a methodologically sound research proposal will need to approach the TalkBank data registry in order to access the data. Prior to the data being deposited in FluencyBank, data sharing requests can be made to Dr Michelle Swift at michelle.swift@unisa.edu.au


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.