Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001584224
Ethics application status
Approved
Date submitted
17/09/2018
Date registered
25/09/2018
Date last updated
18/09/2019
Date data sharing statement initially provided
18/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An Integrated Fluency and Psychosocial Treatment for Adults Who Stutter: Addressing Stuttering and Self-Efficacy
Scientific title
An Integrated Fluency and Psychosocial Treatment for Adults Who Stutter: Addressing Stuttering and Self-Efficacy
Secondary ID [1] 295796 0
None
Universal Trial Number (UTN)
U1111-1218-9306
Trial acronym
The fACTS Program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental stuttering disorders 309229 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308102 308102 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"The fACTS (fluency + Acceptance & Commitment Therapy for Stuttering) Program".
The fACTS Program is an integrated fluency and psychosocial treatment for adolescents (aged 16+) and adults who stutter that aims to address stuttering frequency and self-efficacy by targeting the biological, cognitive/affective, and social components of stuttering simultaneously.

The fACTS Program will be administered by qualified speech pathologists, all of whom are familiar with Acceptance and Commitment Therapy philosophies and experienced in working with adolescents and adults who stutter. All speech pathologists administering the fACTS Program will receive a comprehensive "fACTS Program" manual developed by the primary researcher, as well as a comprehensive half-day training workshop. The "fACTS Program" manual will contain weekly session materials (e.g., handouts, homework activities etcetera) and an overview of the targets to be covered each session.

Participants (i.e., adolescents [aged 16+] and adults who stutter) will take part in eight (8) intervention sessions. These sessions may be conducted weekly or fortnightly in either individual or group sessions, depending on participant availability and preference. Sessions will be conducted face-to-face at the Curtin University Stuttering Treatment Clinic, in private metropolitan community clinics in Australia, or online via video-conferencing services.

Each treatment session will utilise a combination of behavioural fluency techniques (i.e., fluency enhancement or stuttering modification strategies; individualised and selected by each participant based on their personal preference) and Acceptance & Commitment Therapy* targets (i.e., covering all aspects of psychological flexibility). Participants will practice their chosen behavioural fluency techniques whilst participating in the planned Acceptance & Commitment Therapy activities each week.
*Acceptance and Commitment Therapy is a new wave of behavioural psychotherapy. Psychological flexibility at the heart of Acceptance and Commitment Therapy rests on the interplay between six processes - mindfulness, acceptance, defusion, self-as-context, values clarification, and committed action. Psychological flexibility promotes positive experiential living guided by an individual's core values by alleviating some of the tension and struggle associated with persistent developmental stuttering disorders.

To ensure treatment fidelity, each speech pathologist administering the program will complete a standard checklist at the conclusion of each session. This checklist will include items related to the structure of the session, the Acceptance and Commitment Therapy processes targeted, and the behavioural fluency techniques practiced. Checklists will be reviewed by the primary researcher. All externally provided treatment sessions will be audio or video-recorded, and 20% of the sessions will be selected at random to be analysed by an independent observer to ensure adherence to the intervention protocol.
Intervention code [1] 312127 0
Treatment: Other
Intervention code [2] 312128 0
Rehabilitation
Intervention code [3] 312129 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307080 0
Stuttered speech frequency and overall stuttering severity.
Measured using the Stuttering Severity Instrument - 4 (SSI-4; Riley, 2009).
Timepoint [1] 307080 0
Baseline
Immediately post-intervention [primary timepoint]
3-months post-intervention
6-months post-intervention
Primary outcome [2] 307081 0
Self-efficacy for verbal communication.
Measured using the Self-Efficacy Scale for Adults Who Stutter (SESAS; Ornstein & Manning, 1985).
Timepoint [2] 307081 0
Baseline
Immediately post-intervention [primary timepoint]
3-months post-intervention
6-months post-intervention
Primary outcome [3] 307504 0
Generalised self-efficacy.
Measured using the Generalised Self-Efficacy Scale (GSE Scale; Schwarzer & Jerusalem, 1995).
Timepoint [3] 307504 0
Baseline
Immediately post-intervention [primary timepoint]
3-months post-intervention
6-months post-intervention
Secondary outcome [1] 350591 0
Psychological flexibility.
Measured using the Acceptance & Action Questionnaire (AAQ-II; Bond et al., 2011).
Timepoint [1] 350591 0
Baseline
Immediately post-intervention
3-months post-intervention
6-months post-intervention
Secondary outcome [2] 350592 0
Broad impact of stuttering (i.e., knowledge of stuttering, reactions to stuttering, communication in daily situations, and quality of life).
Measured using the Overall Assessment of the Speaker's Experience of Stuttering - Adult (OASES-A; Yaruss & Quesal, 2006).
Timepoint [2] 350592 0
Baseline
Immediately post-intervention
3-months post-intervention
6-months post-intervention
Secondary outcome [3] 350593 0
Self-stigma.
Measured by the Self-Stigma of Stuttering Scale (4S; Boyle, 2013).
Timepoint [3] 350593 0
Baseline
Immediately post-intervention
3-months post-intervention
6-months post-intervention

Eligibility
Key inclusion criteria
Participants are eligible for this clinical trial if the following criteria applies:
- A confirmed diagnosis of developmental stuttering as assessed by a qualified speech pathologist.
- No concomitant speech, language, or hearing difficulties.
- Aged 16 years and over (with parental permission for those aged 16-17).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are not eligible for this clinical trial if any of the following criteria applies:
- Diagnosis of acquired/neurogenic stuttering.
- Participation in Acceptance and Commitment Therapy in the past.
- Currently receiving speech pathology intervention.

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)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
G*Power was used to calculate the required sample size (n = 24) to detect a medium effect in changes to fluency, self-efficacy, and psychological flexibility, in line with previous research.

Quantitative measures include an objective measure of stuttering severity (SSI-4) and the following self-report questionnaires: SESAS, GSE, OASES-A, 4S, AAQ-II.

Data regarding participant age, gender, self-reported stuttering severity (measured on a Likert scale), receipt of previous speech pathology intervention, and number of years of treatment (if applicable) will be collected as covariants.

Data will be analysed using generalised linear mixed modelling (GLMM). Mediation analyses will also be considered dependent on final sample size.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
19/05/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/08/2020
Actual
Sample size
Target
24
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment outside Australia
Country [1] 20772 0
United States of America
State/province [1] 20772 0

Funding & Sponsors
Funding source category [1] 300388 0
University
Name [1] 300388 0
Curtin University
Country [1] 300388 0
Australia
Funding source category [2] 303850 0
Government body
Name [2] 303850 0
Australian Government Research Training Program Stipend Scholarship
Country [2] 303850 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
Kent St
Bentley, Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 299888 0
None
Name [1] 299888 0
Address [1] 299888 0
Country [1] 299888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301197 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 301197 0
Ethics committee country [1] 301197 0
Australia
Date submitted for ethics approval [1] 301197 0
07/09/2018
Approval date [1] 301197 0
18/09/2018
Ethics approval number [1] 301197 0
HRE2018-0624

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

Contacts
Principal investigator
Name 86190 0
A/Prof Janet Beilby
Address 86190 0
Curtin University
Kent St, Bentley WA 6102
Country 86190 0
Australia
Phone 86190 0
+61 8 9266 7463
Fax 86190 0
Email 86190 0
[email protected]
Contact person for public queries
Name 86191 0
Janet Beilby
Address 86191 0
Curtin University
Kent St, Bentley WA 6102
Country 86191 0
Australia
Phone 86191 0
+61 8 9266 7463
Fax 86191 0
Email 86191 0
[email protected]
Contact person for scientific queries
Name 86192 0
Janet Beilby
Address 86192 0
Curtin University
Kent St, Bentley WA 6102
Country 86192 0
Australia
Phone 86192 0
+61 8 9266 7463
Fax 86192 0
Email 86192 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
Data is anonymous and will be aggregated for the group.


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.