Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000845730
Ethics application status
Approved
Date submitted
2/06/2022
Date registered
16/06/2022
Date last updated
23/06/2023
Date data sharing statement initially provided
16/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A group therapy for school-aged children who stutter teaching Acceptance and Commitment Therapy and fluency skills
Scientific title
Speech and psychological outcomes from a group intervention for school-children who stutter incorporating fluency shaping and Acceptance and Commitment therapies
Secondary ID [1] 303667 0
None
Universal Trial Number (UTN)
U1111-1266-0226
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stuttering 321059 0
anxiety 321060 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318866 318866 0 0
Speech therapy
Mental Health 318867 318867 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be 2-3 groups with between 4-6 children in each group. The groups will be held weekly for 1 hour for a period of 7 weeks. The groups will be held face-to-face at a speech pathology clinic.

Group Treatment Protocol
The group treatment program will be facilitated by student speech pathologists, overseen by an experienced Clinical Educator. Sessions will include initial ice-breaker activities to establish rapport and the creation of group communication rules. Fluency techniques will be introduced, and participants will be encouraged to practice these techniques in pairs, with feedback being provided to the participants. During the series of treatment sessions, principles of Acceptance and Commitment Therapy (ACT), will be covered. Examples include coping strategies, the cognitive cycle and defusion. Each session will end with participants summarising the session and establishing goals for the following session.

Session Objectives:
1. Build rapport using ice-breaker games.
2. Establish group communication rules.
3. Introduce fluency techniques.
4. Practice fluence techniques in pairs.
5. Coping strategies for hard speech days.
6. The cognitive cycle, distinguishing between thoughts and feelings.
7. Fusion vs defusion, including defusion strategies.
8. Summarise session.
9. Establish individual and group goals for the following session.
Treating clinicians will complete a group checklist for each child indicating attendance and what aspects of the session they participated in each week.

It is expected that the children will spend between 10 – 15 minutes per day practicing the fluency techniques at home. They are also requested to engage in some self-reflection tasks as part of their homework. Children will be provided with a homework diary to fill in when they complete their home practice (date of homework, what they did, any issues encountered).
Intervention code [1] 323708 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331561 0
Change in Overall Assessment of the Speaker's Experience of Stuttering - School-aged (OASES-S) overall impact rating
Timepoint [1] 331561 0
Pre-treatment
Immediately post-treatment - that is within 1 week of the final group session
6 months post-treatment
Primary outcome [2] 331562 0
Change in percent syllables stuttered during 10 minute speech sample
Timepoint [2] 331562 0
Pre-treatment
Immediately post-treatment - that is within 1 week of the final group session
6 months post-treatment
Secondary outcome [1] 410296 0
Change in stuttering severity rating (0-8) during 10 minute speech sample
Timepoint [1] 410296 0
Pre-treatment
Immediately post-treatment - that is within 1 week of the final group session
6 months post-treatment
Secondary outcome [2] 410297 0
Change in Social Phobia Inventory (SPIN) score
Timepoint [2] 410297 0
Pre-treatment
Immediately post-treatment - that is within 1 week of the final group session
6 months post-treatment
Secondary outcome [3] 410298 0
Change in Communication Attitude Test score
Timepoint [3] 410298 0
Pre-treatment
Immediately post-treatment - that is within 1 week of the final group session
6 months post-treatment
Secondary outcome [4] 410299 0
Change in Palin Parent Rating Scales
Timepoint [4] 410299 0
Pre-treatment
Immediately post-treatment - that is within 1 week of the final group session
6 months post-treatment
Secondary outcome [5] 410300 0
Change in Social Phobia and Anxiety Inventory for Children (SPAI-C) score
Timepoint [5] 410300 0
Pre-treatment
Immediately post-treatment - that is within 1 week of the final group session
6 months post-treatment
Secondary outcome [6] 410301 0
Change in Spence Children's Anxiety Scale score
Timepoint [6] 410301 0
Pre-treatment
Immediately post-treatment - that is within 1 week of the final group session
6 months post-treatment
Secondary outcome [7] 410762 0
60 minute face-to-face interviews with individual children and their parent(s) will be conducted by a member of the research team to discover participant perceived outcomes and the contexts and mechanisms leading to the outcomes measured by the quantitative measures. Interviews will be semi-structured using an interview guide that will be updated as the study progresses to further investigate ideas arising from the early interviews.
Timepoint [7] 410762 0
1 month post-treatment
Secondary outcome [8] 410763 0
60 minute face-to-face individual interviews with the treating clinicians who ran the groups will be conducted by a member of the research team to discover the contexts and mechanisms leading to participant outcomes. Interviews will be semi-structured using an interview guide that will be updated as the study progresses to further investigate ideas arising from the early interviews.
Timepoint [8] 410763 0
1 month post-treatment

Eligibility
Key inclusion criteria
Inclusion criteria for participant selection, includes:
• Age, between 8;0 and 12;0 years old
• Stuttering Severity Rating of 2 or above
• Overall score on the OASES-S of ‘mild to moderate’ or higher
• A level of English proficiency that enables participation in group or individual treatment without the use of an interpreter
• Written consent
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Written consent not obtained, or consent withdrawn during the study

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
Efficacy
Statistical methods / analysis
Quantitative Data
Data will be imported into SPSS and analysed using group cohort pre-/post-design for each treatment utilising repeated measures ANOVA if normally distributed or the Friedman’s test of repeated measures. Treatment effect sizes will be calculated to determine the exact number of participants required for sufficient statistical power for a randomised controlled trial comparing the two treatments versus treatment without the ACT component.

Qualitative Data
Semi-structured interviews will be transcribed and coded for reported contexts and mechanisms contributing to the observed outcomes.

Quantitative outcome and questionnaire data will be combined with qualitative interviews to elicit the contexts and mechanisms contributing to outcomes in an individual case. Data from a number of cases are combined to form Context Mechanism Outcome (CMO) configurations which take the form of Context + Mechanism = Outcome.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/07/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 308086 0
University
Name [1] 308086 0
Flinders University
Country [1] 308086 0
Australia
Funding source category [2] 314141 0
University
Name [2] 314141 0
University of South Australia
Country [2] 314141 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Registry Road
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 308827 0
None
Name [1] 308827 0
Address [1] 308827 0
Country [1] 308827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308072 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 308072 0
Ethics committee country [1] 308072 0
Australia
Date submitted for ethics approval [1] 308072 0
Approval date [1] 308072 0
06/03/2019
Ethics approval number [1] 308072 0
2020/HRE01497

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

Contacts
Principal investigator
Name 109430 0
Dr Michelle Swift
Address 109430 0
UniSA Allied Health & Human Performance, GPO Box 2471 Adelaide SA 5001
Country 109430 0
Australia
Phone 109430 0
+61 8 8302 7782
Fax 109430 0
Email 109430 0
[email protected]
Contact person for public queries
Name 109431 0
Michelle Swift
Address 109431 0
UniSA Allied Health & Human Performance, GPO Box 2471 Adelaide SA 5001
Country 109431 0
Australia
Phone 109431 0
+61 8 8302 7782
Fax 109431 0
Email 109431 0
[email protected]
Contact person for scientific queries
Name 109432 0
Michelle Swift
Address 109432 0
UniSA Allied Health & Human Performance, GPO Box 2471 Adelaide SA 5001
Country 109432 0
Australia
Phone 109432 0
+61 8 8302 7782
Fax 109432 0
Email 109432 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified transcripts from the interviews and speech samples, deidentified questionnaires
When will data be available (start and end dates)?
Immediately post-publication for 7 years
Available to whom?
Researchers with a methodologically sound proposal
Available for what types of analyses?
Critical realistic evaluation, linguistic analysis, qualitative analysis, meta-analysis
How or where can data be obtained?
Via the principal researcher - Dr Michelle Swift - [email protected]


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.