Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000694718
Ethics application status
Approved
Date submitted
26/04/2022
Date registered
13/05/2022
Date last updated
5/10/2024
Date data sharing statement initially provided
13/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Neuroplasticity in Children Who Stutter (CWS): investigating any behavioural and neurological changes after stuttering therapy
Scientific title
Neuroplasticity in Children Who Stutter (CWS): investigating any behavioural and neurological changes after stuttering therapy
Secondary ID [1] 305484 0
None
Universal Trial Number (UTN)
U1111-1270-2420
Trial acronym
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Developmental stuttering 323869 0
Condition category
Condition code
Neurological 321384 321384 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main goal of this research is to identify structural and functional brain differences between children who stutter (CWS) and children who do not stutter (CWNS) and how these differences change due to stuttering therapy in CWS.
This research consists of three studies to achieve three goals of the study:
1. To identify the structural and functional neural correlates of developmental stuttering in children close to stuttering onset (study 1)
2. To identify the effect of stuttering therapy on speech fluency and the emotional and psychosocial functioning of children who stutter and their whanau (family) (study 2)
3. To Link treatment-induced behavioural changes (Specific to study 2) with treatment-induced neural changes (study 3)
Forty participants will take part in the research. All participants will complete study 1 to identify brain differences between 20 CWS and 20 CWNS. Study 2 and 3 will include the same 20 CWS following same timeline. Control group (CWNS) will participate in study 1 only and will undergo speech-language assessments and MRI scan only once.
Children who stutter (CWS) will participates in all of the three studies. CWS will go through speech-language assessments 4 times, each 8 weeks apart: 8 weeks before starting stuttering therapy (baseline), pre-therapy, post-therapy and 8 weeks post therapy. CWS will undergo MRI scan 3 times, each 8 weeks apart: 8 weeks before starting stuttering therapy (baseline), pre-therapy and post-therapy. The three studies involve:
Study 1:
• Collection of background and speech-language information
• Brain scan using Magnetic Resonance Imaging (MRI)
-Background information: questions about child’s speech and language, including some general information, for example, medical history of the child and milestones developments (e.g., when the child started walking or said 1st word).
-Speech and language assessments: children will undergo a comprehensive assessment including a case history and six assessments of speech and language. Speech and language assessments will take 2-3 hours in total and can be done over 2 separate sessions, depending on each child’s abilities and needs. Speech and language assessments will take place at the University of Canterbury while the brain scan will be conducted in St George’s Hospital in Christchurch.
-Brain scan: children will undergo a 1 hour of Magnetic Resonance Imaging’ (MRI) scan session (including preparation + 35 minutes scan time). A trained speech and language therapist will attend the session to prepare the participating children for the MRI scan using the “submarine protocol” (Theys et al., 2014) to make it a fun experience. The MRI scans will be conducted and reviewed by a specialist radiologist.
*Total time for study 1 is 2-3 hours of speech-language assessments and 1 hour of MRI scan.
Study 2: (CWS only)
• Children who stutter will receive 8 weeks of stuttering therapy (RESTART-DCM)
• Speech-language assessments and questionnaire regarding impact of stuttering will be collected pre and post stuttering therapy
Therapy: Children who stutter will receive 8 weeks of 1 to 1 speech and language therapy sessions using a stuttering therapy called the Demands and Capacities Model treatment (RESTART-DCM). It is a stuttering therapy program that is designed to help reduce stuttering and the impact of stuttering on your child’s daily life. It is an evidence-based treatment. This treatment approach is as effective (Franken et al., 2005; de Sonneville-Koedoot et al., 2015), and a better fit with the whanau-centred strength-based approach to treatment that we prioritised following Maori consultation.
Participants will receive 12 hours of therapy. The general structure of a treatment session will be guided by RESTART-DCM methods published by Franken and Laroes (2021).
Each treatment session takes about 1 hour and will include a discussion with parents of changes in child’s disfluency, revision of modified speech behaviour and modelling by the therapist when needed, practise of the techniques, time for answering questions and making notes in the parent’s logbook. Parent’s involvements in the treatment is important and a parent must attend treatment session.
An essential part of the RESTART-DCM program is that a parent spends 10 minutes, 5 times a week, playing with their child and implementing the learnt modified speech behaviour. In addition, parents are requested to keep daily recording of stuttering severity, which is a simple process that takes few minutes a day. The general structure of a treatment session will be guided by RESTART-DCM methods published by Franken and Laroes (2021).
Flexibility to session’s structure will be applied when needed using clinical judgements to make sure maximum benefits of the therapy are achieved. Ideally, individual therapy sessions will be offered twice a week in the 1st month and once a week in the 2nd month, however, individual circumstances, including physical well-being and whanau support available dictate a need for flexibility. Completion of the therapy will be dependent on participant availability, their needs and issues such as Fatigue or sickness. After completion of this treatment, participants will be reviewed after about 8 weeks for follow-up assessments and further treatment as individually required. No strategies are used to monitor adherence to the intervention.
Stuttering treatment will be provided by PhD student Grout-Brown, who is a NZ-registered (NZSTA) speech language therapist and has participated in a workshop on RESTART-DCM. She will be supported and guided by her research supervisors Theys and Beal. Treatment will focus on reduction of severity and frequency of stuttering and attitude toward stuttering. Speech treatment will take place in the Speech and Hearing Clinics at the University of Canterbury. These clinics are equipped with purpose-built hard-wired recording devices to ensure that treatment sessions can be recorded for off-line data analysis without being intrusive during the sessions.
Speech-language assessment: we will repeat speech-language assessments pre and post therapy to identify speech fluency changes related to therapy. Speech and language assessments will take 2-3 hours in total and can be done over 2 separate sessions, depending on each child’s abilities and needs. Speech and language assessments will take place at the University of Canterbury while the brain scan will be conducted in St George’s Hospital in Christchurch.
*Total time for study 2 is 12 hours of stuttering therapy over a period of 8 weeks and about 2 hours of speech-language assessments repeated in 3 different times (8 weeks apart): pre-therapy, post-therapy and 8 weeks post therapy.
Study 3: (CWS only)
• MRI scans pre and post therapy
CWS will undergo MRI scans pre and post therapy. MRI scan session is 1 hour long (including preparation + 35 minutes scan time). A trained speech and language therapist will attend the session to prepare the participating children for the MRI scan using the “submarine protocol” (Theys et al., 2014) to make it a fun experience. The MRI scans will be conducted and reviewed by a specialist radiologist. This study will help us to compare scans from before and after treatment to look for changes in the brain relating to the treatment.
*Total time for study 3 is 2 hours of MRI scans (each scan is 8 weeks apart): pre-therapy and post-therapy.
Intervention code [1] 321886 0
Behaviour
Intervention code [2] 323495 0
Treatment: Other
Comparator / control treatment
study1: CWNS will be the control group
Behavioural and neuroimaging data in CWS will be compared to control group (CWNS) to achieve goal 1.
Study 2 and 3 of the study: CWS will act as their own control.
CWS will have about 8 weeks of no therapy provided after initial MRI scan to establish a baseline. This period of baseline will be followed by another MRI scan to examine normal brain changes when no therapy is provided and confirm if fluency and brain changes that will be seen in the following treatment block (study 2) are attributed to therapy or not.
Similar method was used in CWS behavioural stuttering treatment studies by Millard et al. (2019) and Millard et al. (2019).
This method will allow us to follow best practice multiple-baseline group treatment methodology. Withholding stuttering treatment will not cause any harm or affect therapy progress. This ‘wait’ time is shorter than typical current waiting-list for speech treatment.

20 CWS will receive 8 weeks of stuttering treatment. Stuttering treatment will be given in 4 blocks of 5 CWS at one time, spread over 16 months. CWS will receive the stuttering treatment after 8 week period of study 1 scan. Timing of intervention delivery will be determined based on the participant's enrolment time.
Control group
Active

Outcomes
Primary outcome [1] 330469 0
-A comparison of brain structure and function in children who stutter vs. children who do not stutter, assessed by MRI.
Timepoint [1] 330469 0
8 weeks pre-therapy (baseline).
Primary outcome [2] 331268 0
-A comparison of pre- and post-treatment speech fluency in children who stutter, assessed by percentage of syllables stuttered in a speech sample.
Timepoint [2] 331268 0
pre-therapy, within 1 week post-therapy and at 8 weeks post therapy (f/u).
Primary outcome [3] 331271 0
-A comparison of pre- and post-treatment brain changes in children who stutter, assessed by MRI.
Timepoint [3] 331271 0
pre-therapy and within 1 week post-therapy.
Secondary outcome [1] 406344 0
Impact of stuttering on CWS and their parents and the parents’ knowledge about stuttering using the Palin Parent Rating Scale.
Timepoint [1] 406344 0
8 weeks pre-therapy (baseline), pre-therapy, within 1 week post-therapy and at 8 weeks post therapy (f/u).
Secondary outcome [2] 409383 0
Severity of stuttering assessed using the Stuttering Severity Instrument (SSI-4).
Timepoint [2] 409383 0
8 weeks pre-therapy (baseline), pre-therapy, within 1 week post-therapy and at 8 weeks post therapy (f/u).
Secondary outcome [3] 409384 0
Self-perceptions of individuals’ dysfluencies using KiddyCAT in Pre-schooler
Timepoint [3] 409384 0
8 weeks pre-therapy (baseline), pre-therapy, within 1 week post-therapy and at 8 weeks post therapy (f/u).

Eligibility
Key inclusion criteria
There will be two groups of participants:

- CWS: children who have been diagnosed with developmental stuttering by a qualified speech and language therapist.
- CWNS (control): children who have fluent speech and are matched for sex, age, and handedness with the CWS.

Inclusion criteria for both groups
- Children of any sex aged 4 to 7 years.
- Monolingual New Zealanders English speakers.
Minimum age
4 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for CWS
- Child younger then 4 or older than 7 yeras of age.
- NZ child speaking more than one language fluently.
- Child presents with developmental or neurological disorders (e.g. dyslexia, ADHD, learning delay or any obvious speech and language disorder other than stuttering). children presented with mild speech delay are included.
- Child presents with stuttering that is not developmental (e.g. due to stroke).

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
Other
Other design features
Study 1 will be a case-control comparison study of CWS and CWNS
Study 2 will be a single group study of the effect of the intervention on speech fluency in CWS only
Study 3 will be a single group study of the effect of the intervention on brain structure and functioning in CWS only
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proposed number of 20 CWS is sufficient for this study and was selected following power calculations based on our data in adults with developmental stuttering and the causal networks identified using lesion network mapping (Fox , 2018; Joutsa et al., 2018) in adults with neurogenic stuttering. Structural (grey matter) values of the difference between the adults who stutter and controls showed and effect size (Cohen’s d) of 0.81. With 20 participants per group, this effect size (d=0.81) at alpha=0.05 gives 70% power to detect an effect of equal or greater size. Twenty participants per group (and alpha=0.05), leads to 80% power to identify an effect of 0.91 (two-tailed) or 0.8 (one-tailed).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/05/2022
Actual
1/06/2022
Date of last participant enrolment
Anticipated
28/03/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
40
Accrual to date
18
Final
Recruitment outside Australia
Country [1] 24582 0
New Zealand
State/province [1] 24582 0
Christchurch

Funding & Sponsors
Funding source category [1] 309842 0
Charities/Societies/Foundations
Name [1] 309842 0
Canterbury Medical Research Foundation in New Zealand
Country [1] 309842 0
New Zealand
Primary sponsor type
Individual
Name
Wallis Grout-Brown
Address
School of Psychology, Speech, and Hearing
University of Canterbury
20 Kirkwood Ave, Ilam
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 312026 0
None
Name [1] 312026 0
Address [1] 312026 0
Country [1] 312026 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309582 0
The Southern Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 309582 0
Ethics committee country [1] 309582 0
New Zealand
Date submitted for ethics approval [1] 309582 0
13/01/2022
Approval date [1] 309582 0
09/05/2022
Ethics approval number [1] 309582 0
2022 FULL 11228

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

Contacts
Principal investigator
Name 114666 0
Ms Wallis Grout-Brown
Address 114666 0
School of Psychology, Speech, and Hearing
University of Canterbury
20 Kirkwood Ave, Ilam
Christchurch 8140
Country 114666 0
New Zealand
Phone 114666 0
+64 033693662
Fax 114666 0
Email 114666 0
[email protected]
Contact person for public queries
Name 114667 0
Wallis Grout-Brown
Address 114667 0
School of Psychology, Speech, and Hearing
University of Canterbury
20 Kirkwood Ave, Ilam
Christchurch 8140
Country 114667 0
New Zealand
Phone 114667 0
+64 033693662
Fax 114667 0
Email 114667 0
[email protected]
Contact person for scientific queries
Name 114668 0
Wallis Grout-Brown
Address 114668 0
School of Psychology, Speech, and Hearing
University of Canterbury
Private Bag 4800
20 Kirkwood Ave, Ilam
Christchurch 8140
Country 114668 0
New Zealand
Phone 114668 0
+64 033693662
Fax 114668 0
Email 114668 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
All data will be de-identified and data will be analysed in a group and not individually


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15644Study protocol  [email protected]
15645Informed consent form  [email protected]
15646Other  [email protected] Data Management Plan



Results publications and other study-related documents

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