Trial Review

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
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001037493
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
1/09/2025
Date registered
Help: Date registered
19/09/2025
Date last updated
Help: Date last updated
25/09/2025
Date data sharing statement initially provided
Help: Data sharing statement date
19/09/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Trialling group improv and acceptance and commitment therapy as a treatment for childhood stuttering
Scientific title
Group improv including acceptance and commitment therapy treatment for children and teens who stutter: A Phase I trial
Additional trial identifiers [1] 301271 0
Channel 7 Children's Research Foundation project reference 25-45948821
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Stuttering 338668 0
Anxiety 338669 0
Condition category
Condition code
Mental Health 334958 334958 0 0
Anxiety
Physical Medicine / Rehabilitation 334960 334960 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Description of intervention(s) / exposure:
Implementation of Improv groups will each occur over a 6-week period (during a school term) with sessions run once per week for 2 hours.

Improv groups will be divided by age (7-9 years, 10-12 years, 13-15 years) into 4-5 cohorts of children/teens who stutter (8-10 children per group).

Thirty-two to 40 children and teens will be recruited to participate in the study, allowing for at least one group per age-range while providing flexibility for an additional group in one or two age-groups depending on participant interest.

One or two groups will be run per term in Term 4, 2025, and/or Terms 1 and 2, 2026.

Groups will be held in a rented community hall in a location central to the group participants in Adelaide, South Australia.

A speech pathologist with stuttering treatment and improv teaching experience and an improv teacher will be employed as a Research Clinicians to run the groups.

All age groups receive the same content but adapted for age.

Course content summary:

Weeks 1-2: 1st session- values establishment, rapport building, trust building, and simple games,

Establish what is an “o?er”, how do you make one. (An o?er is any dialog or action which advances the scene or a game. All o?ers should be accepted, however, there are some exceptions/ rules to maintain participant safety).

Weeks 3-4: Progress to “Troupe/Teamwork” drama games.

Weeks 5-6: Progress to “O?er and acceptance”: “yes, and…” kind of games

Hierarchy of Games:

1. Rapport Building/ Non-Talking games.

2. Games to encourage dealing with failure + talking.

3. Games with more words

Number of games per class: class is designed to include between 8-10 games and 2x 15-minute breaks; Games will run for around 10 minutes each.

To assess adherence to the intervention there will be an attendance checklist and a fidelity checklist completed on recordings of the sessions.

ACT will be incorporated into each session. In session one, participant values and group norms will be established.

Some of the improv games allow for the opportunity to reflect on attitudes towards the situation. ACT approach is conducted during these guided reflection sessions, rather than being overtly discussed.

All sessions will have an ACT/reflection portion which will include:

ACT/Reflection Prompts
Reflection (10 mins): How was that? What was easy/ hard?
What was that like for you?"
"What was fun or surprising about that?"
"Did any tricky thoughts show up? Like 'I need to be good at this”, or “I need to pre-plan what I’m going to say”.
"Did you notice any part of you wanting to hide? Or maybe a part that wanted to try anyway?"

Facilitators will use and encourage open, non-judgemental questioning, with an emphasis on exploring experiences rather than focusing on outcomes. The approach aims to normalise thoughts and feelings, reframe perceived failure, and invite "next time" thinking to support personal growth and resilience.

Co-design process:

The program was co-designed by a diverse group that included facilitators with backgrounds in allied health and the arts, along with adults from the improv community, children and adults who stutter, and adults who have experience with or incorporate Acceptance and Commitment Therapy (ACT) into their personal or professional practice.

Stakeholders were introduced to the foundations of both improv and ACT, and were invited to share their personal experiences with stuttering. They actively participated in improv games, with opportunities for guided reflection and voting on which games they felt were suitable for inclusion in the course.

Participants in the co-design process took part in five 2-hour workshops, spaced three weeks apart, allowing time for reflection and integration between sessions.

At the conclusion of the fourth workshop, a draft version of the program was shared with all stakeholders, who were then invited to provide feedback to the research team which was finalised during the fifth workshop.
Intervention code [1] 331831 0
Treatment: Other
Intervention code [2] 331832 0
Behaviour
Intervention code [3] 331833 0
Rehabilitation
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342623 0
Stuttering impact Assessment method - changes to overall impact rating on the Overall Assessment of the Speakers Experience of Stuttering (OASES). OASES-S (7-12 year olds) and OASES-T (13-15 year olds).
Timepoint [1] 342623 0
Pre-treatment (baseline); Immediately post-treatment - that is within 1 week of the final group session (primary timepoint); 3 months post-completion of the treatment program
Primary outcome [2] 342624 0
Composite outcome assessing participant perceived outcomes and changes in communicative self-efficacy Assessment method - 30 minute face-to-face interviews with individual participants 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 [2] 342624 0
3 months post-completion of the treatment program
Primary outcome [3] 342625 0
Changes in communication attitude Assessment method - Behaviour Assessment Battery (BAB) for children 6–15 - Communication Attitude Test (CAT) subtest
Timepoint [3] 342625 0
Pre-treatment (baseline); Immediately post-treatment - that is within 1 week of the final group session (primary timepoint); 3 months post-completion of the treatment program
Secondary outcome [1] 451558 0
Intervention fidelity: Was the improv+ACT program implemented as designed? Assessed by session recordings and fidelity checklists by a research assistant.
Timepoint [1] 451558 0
Post-intervention (1-3 months post-completion of the therapy block)
Secondary outcome [2] 451721 0
Acceptability: Qualitative interviews with children and parents will be conducted face-to-face or via Zoom/Teams 3 months post-group, exploring experience, perceived changes, and feedback. Interviews will be transcribed and member-checked before analysis.
Timepoint [2] 451721 0
3 months post-completion of the therapy block
Secondary outcome [3] 451722 0
Communication attitude during group sessions Assessment method - Situational Communication Apprehension Measure (SCAM) - used at the end of each group session to measure communication attitude during the group.
Timepoint [3] 451722 0
During intervention - at the end of each intervention session
Secondary outcome [4] 451723 0
Stuttering severity Assessment method - 10-minute speech samples in clinic and via phone or home recording rated by two independent speech pathologists blinded to time point, on a 0–10 severity scale (0=no stuttering, 10=severe).
Timepoint [4] 451723 0
Pre-treatment (baseline); Immediately post-treatment - that is within 1 week of the final group session; 3 months post-completion of the treatment program
Secondary outcome [5] 451724 0
Communication effectiveness Assessment method: 10-minute speech samples in clinic and via phone or home recording rated by two independent speech pathologists blinded to time point, on a 0–10 communication effectiveness scale (0= not at all effective, 10= completely effective).
Timepoint [5] 451724 0
Pre-treatment (baseline); Immediately post-treatment - that is within 1 week of the final group session; 3 months post-completion of the treatment program
Secondary outcome [6] 451725 0
Emotional responses to stuttering Assessment method: Behaviour Assessment Battery (BAB) for children 6–15 - Speech Situation Checklist - Emotional Response subtest
Timepoint [6] 451725 0
Pre-treatment (baseline); Immediately post-treatment - that is within 1 week of the final group session; 3 months post-completion of the treatment program
Secondary outcome [7] 451726 0
Self-perceived communication competence Assessment method - Self-perceived communication competence Scale (SPCC)
Timepoint [7] 451726 0
Pre-treatment (baseline); Immediately post-treatment - that is within 1 week of the final group session; 3 months post-completion of the treatment program
Secondary outcome [8] 451727 0
Changes in anxiety levels Assessment method - Spence Children’s Anxiety Scale (SCAS), child self-report with Australian norms (8–15), assessing anxiety across six domains
Timepoint [8] 451727 0
Pre-treatment (baseline); Immediately post-treatment - that is within 1 week of the final group session; 3 months post-completion of the treatment program
Secondary outcome [9] 452107 0
Combined outcome assessing changes in quality of life and social participation Assessment method: changes to the OASES-S or OASES-T Section IV impact score
Timepoint [9] 452107 0
Pre=treatment (baseline); Immediately post-treatment - that is within 1 week of the final group session; 3 months post-completion of the treatment program

Eligibility
Key inclusion criteria
Inclusion: children aged between 7-15 years old, identify as stuttering for at least 6 months and either have an overt stutter with a severity rating at least 2 (0-10 scale) or at least a mild-moderate impact on the OASES, Participants must be able to speak sufficient English without use of an interpreter that enables full participation in therapy. This will be determined by Dr. Michelle Swift.
Minimum age
7 Years
Maximum age
15 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Exclusion: receiving other speech pathology therapy for stuttering at the same time as the improv group, 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Qualitative data will be analysed thematically to identify both semantic or literal themes and latent or implicit themes within the data (Macguire & Delahunt, 2017; Braun & Clarke, 2006). Braun and Clarke’s six-phases of thematic analysis will be followed: 1) Data familiarisation, 2) Generating initial codes, 3) Searching for themes through code categorisation, 4) Reviewing themes against the transcripts, 5) Defining themes and identifying sub-themes, 6) Writing up the results.
Initial coding of the interview data (phases 1 & 2) will be completed by the research team. Categorisation and theming (phases 3 & 5) will then be completed collaboratively by the co-design group (Ethics protocol # 206720) and researchers during two co-design workshops after the group implementation. The research team will complete phase 4 in-between the two workshops. At each stage Braun and Clarke’s 15-point checklist of criteria for good thematic analysis will be used to ensure rigour.
Quantitative data will be analysed descriptively, and effect sizes calculated to inform power analysis for a definitive trial. The mix of quantitative and qualitative data will be informed by a critical realist evaluation approach to form a program theory documenting internal and external factors that are proposed to contribute to a participant's outcomes following the improv therapy. This program theory will be tested in the next phase of research and used to inform future program design.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/10/2025
Actual
Date of last participant enrolment
Anticipated
4/05/2026
Actual
Date of last data collection
Anticipated
31/10/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 305717 0
Charities/Societies/Foundations
Name [1] 305717 0
Channel 7 Children's Research Foundation
Country [1] 305717 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 306136 0
None
Name [1] 306136 0
Address [1] 306136 0
Country [1] 306136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305993 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 305993 0
Ethics committee country [1] 305993 0
Australia
Date submitted for ethics approval [1] 305993 0
13/08/2025
Approval date [1] 305993 0
18/09/2025
Ethics approval number [1] 305993 0
207216

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

Contacts
Principal investigator
Name 102342 0
Dr Michelle Swift
Address 102342 0
Speech Pathology, UniSA Allied Health & Human Performance, GPO Box 2471, Adelaide 5001
Country 102342 0
Australia
Phone 102342 0
+61 8 83027782
Fax 102342 0
Email 102342 0
[email protected]
Contact person for public queries
Name 102343 0
Dr Michelle Swift
Address 102343 0
Speech Pathology, UniSA Allied Health & Human Performance, GPO Box 2471, Adelaide 5001
Country 102343 0
Australia
Phone 102343 0
+61 8 83027782
Fax 102343 0
Email 102343 0
[email protected]
Contact person for scientific queries
Name 102344 0
Dr Michelle Swift
Address 102344 0
Speech Pathology, UniSA Allied Health & Human Performance, GPO Box 2471, Adelaide 5001
Country 102344 0
Australia
Phone 102344 0
+61 8 83027782
Fax 102344 0
Email 102344 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Safety data
• Videos and audio recordings of speech samples

What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: FluencyBank

• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.