Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001343392
Ethics application status
Approved
Date submitted
13/09/2017
Date registered
22/09/2017
Date last updated
25/07/2019
Date data sharing statement initially provided
25/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Managing fluency and disruptive behaviours in children who stutter: An integrated behavioural and stuttering treatment program
Scientific title
Managing fluency and disruptive behaviours in children who stutter: An integrated behavioural and stuttering treatment program
Secondary ID [1] 292880 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
developmental stuttering disorder 304725 0
Condition category
Condition code
Neurological 304036 304036 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 304134 304134 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will comprise three groups of children who stutter.
Group 1: Children who stutter with disruptive behaviours who receive stuttering therapy only.
Group 2: Children who stutter without disruptive behaviour who receive stuttering therapy only.
Group 3: Children who stutter with disruptive behaviours who receive stuttering therapy, in addition the Group Triple P Program.

Stuttering therapy will be overseen by speech pathologists who have 10 years of specialised experience in the assessment and management of stuttering disorders. Stuttering therapy sessions will be delivered face-to-face, in individual sessions. The duration of stuttering therapy will be 12 weeks for all children, involving 1x hourly session per week delivered weekly. Sessions will take place at the Curtin University Treatment Clinic or in private metropolitan community clinics in Western Australia. The parent is encouraged to observe therapy sessions (between clinician and child) where the clinician implements stuttering therapy. The child is required to play and engage with the clinician during therapy using age appropriate fun activities such as: Play Doh, Go Fish, Shopping Game. Stuttering therapy principles will be implemented during these activities, mapping on to the Demands and Capacities Model as well as using Response Contingent Stimulation principles.

The Triple P Program will be delivered by a registered Triple P Provider over an 8 week period. Parents will attend this training without their children. This will comprise of 3x 2-hour face-to-face group sessions weekly, then 3x individual 20-30 minute telephone calls delivered weekly, followed by a final 2-hour face-to-face session in the final week of the program. The Triple P training will be provided to parents at the Curtin University Stuttering Treatment clinics. It is a standardised and well recognised family behavioural intervention. Parents will learn strategies to encourage positive parenting, improve parent-child relationships and learn how to better manage their child's behaviour. Parents receiving the training will be provided with a work book to complete as part of their training, entitled "Every Parent's Group Workbook".

To ensure treatment fidelity of fluency therapy, each therapist will complete standard checklists after each session (including session structure and stuttering treatment principles implemented). Sessions will be video recorded and 10% randomly analysed by an independent observer. Rater reliability will be assessed. A similar process will be followed for the Triple P Program. All group sessions will be video-recorded, the Triple P provider will complete a standardised Triple P fidelity checklist at the end of each group session, and 10% of sessions will be rated by an external reviewer.
Intervention code [1] 299120 0
Treatment: Other
Comparator / control treatment
Two active unenhanced control groups (Group 1 and Group 2).

Group 1: Children who stutter (aged 2-6 years) with disruptive behaviours who receive stuttering therapy only.
Group 2: Children who stutter (aged 2-6 years) without disruptive behaviour who receive stuttering therapy only.

Both groups do not receive the Triple P component as part of their management, thus making up the active unenhanced control groups. Both groups are not withheld from stuttering therapy.
Control group
Active

Outcomes
Primary outcome [1] 303370 0
Stuttering Severity. This is assessed by calculating percentage of syllables stuttered by a speech pathologist.
Timepoint [1] 303370 0
12 weeks post treatment and at 3 months follow-up
Primary outcome [2] 303371 0
Parenting Practices - assessed by the Parenting and Family Adjustment Scales (PAFAS)
Timepoint [2] 303371 0
12 weeks post treatment and at 3 months follow-up
Primary outcome [3] 303372 0
Child Disruptive Behaviours - assessed by (1) the Strengths and Difficulties Questionnaire and (2) Effortful Control Subscale of the Child Behavior Questionnaire
Timepoint [3] 303372 0
12 weeks post treatment and at 3 months follow-up
Secondary outcome [1] 338761 0
Qualitative understanding of the effect of the Triple P Program on stuttering, parenting and child behavioural outcomes. This is a composite secondary outcome.

Qualitative interviews will be conducted and thematically analysed using QSR Nvivo 8 qualitative analysis software.
Timepoint [1] 338761 0
12 weeks post treatment

Eligibility
Key inclusion criteria
Children:
- Hearing within normal limits (assessed by parent report following compulsory Western Australian hearing screen at birth)
- Presence of developmental stuttering disorder as diagnosed by a speech pathologist
- Speech and language within normal limits

Parents:
- No regular contact with another professional service for child behavioural problems
- No regular contact with another professional service for parenting support

Children will be classified into groups using the ADHD Rating Scale.
The following cut-off criteria will be applied for grouping, based on Donaher and Richels (2012): children will be classified as presenting with disruptive behaviours if they score a rating of 2 (often) or greater on any 2 items related to inattention (inattentive type), or any 2 items related to hyperactivity/ impulsivity (hyperactive/impulsive type). In addition, the participant’s overall score on the scale has to be greater than the 80th percentile for their gender (DuPaul et al., 1998; McGoey et al., 2007).
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Regular contact with another professional service for child behavioural problems.
- Regular contact with another professional service for parenting support.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/09/2017
Actual
31/10/2017
Date of last participant enrolment
Anticipated
1/02/2019
Actual
5/02/2019
Date of last data collection
Anticipated
2/08/2019
Actual
20/06/2019
Sample size
Target
120
Accrual to date
Final
77
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 297505 0
University
Name [1] 297505 0
Curtin University
Country [1] 297505 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Townsing Drive, Bentley, Perth WA, 6102
Country
Australia
Secondary sponsor category [1] 296516 0
None
Name [1] 296516 0
None
Address [1] 296516 0
N/A
Country [1] 296516 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298605 0
Curtin Human Research Ethics Committee
Ethics committee address [1] 298605 0
Ethics committee country [1] 298605 0
Australia
Date submitted for ethics approval [1] 298605 0
28/08/2017
Approval date [1] 298605 0
23/06/2017
Ethics approval number [1] 298605 0

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

Contacts
Principal investigator
Name 77634 0
A/Prof Janet Beilby
Address 77634 0
Curtin University
Kent St, Bentley WA 6102
Country 77634 0
Australia
Phone 77634 0
+61 8 9266 7463
Fax 77634 0
Email 77634 0
[email protected]
Contact person for public queries
Name 77635 0
Janet Beilby
Address 77635 0
Curtin University
Kent St, Bentley WA 6102
Country 77635 0
Australia
Phone 77635 0
+61 8 9266 7463
Fax 77635 0
Email 77635 0
[email protected]
Contact person for scientific queries
Name 77636 0
Janet Beilby
Address 77636 0
Curtin University
Kent St, Bentley WA 6102
Country 77636 0
Australia
Phone 77636 0
+61 8 9266 7463
Fax 77636 0
Email 77636 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
Privacy


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.