Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001552774
Ethics application status
Approved
Date submitted
5/12/2022
Date registered
15/12/2022
Date last updated
20/06/2024
Date data sharing statement initially provided
15/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
How can we make grammar learning easier for children with language disorders?
Scientific title
Does speech therapy Involving graduated input type variations (GITV) for children with Developmental Language Disorder (DLD) improve their use of grammar?
Secondary ID [1] 308554 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
developmental language disorders 328415 0
Condition category
Condition code
Physical Medicine / Rehabilitation 325438 325438 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this clinical trial, we will examine a new theory driven and empirically based approach on grammar intervention, called graduated input type variation (GITV). The intervention involves evidence-based procedures, recast and focused stimulation, in which the speech language pathologist uses a special way of commenting on what is going on and responding to the child’s communication attempts while playing a toy set, or a game, or reading a book with the child. No tools are required in the use of these procedures. Recast and focused stimulation are different in that the former requires the speech-language pathologist to respond to what the child says by using the grammar target being trained. In focused stimulation, the speech-language pathologist can initiate a comment using the grammar target without having the child say something first. Both procedures are typically included in the standard-of-care of children with language disorders during language intervention.

In the intervention phase, the speech-language pathologist will see the child one-on-one THREE TIMES A WEEK FOR 5 WEEKS, for about an hour each time. About half an hour will be spent on the intervention and the remaining time will be spent on the criterion-referenced probes for monitoring progress. We use AN ONLINE format in which ALL sessions ARE CONDUCTED ONLINE.

We will use a fidelity checklist to monitor the speech-language pathologist's administration of the intervention protocol and to guide the provision of feedback either during the session or after the session through a review of the video recording by an independent observer. We will keep an attendance record and provide a make up session when the child is unavailable on the scheduled time.

In the maintenance session, there will be no intervention. We will re-run the criterion-referenced probes to continue to monitor the child's progress over a period of 6 weeks. There will be three sessions, at 1 week, 3 weeks and 6 weeks post intervention. Each will last about 30 minutes.
Intervention code [1] 325004 0
Treatment: Other
Comparator / control treatment
this trial makes use of a single subject experimental study design and each participant serves as his or her own control
Control group
Active

Outcomes
Primary outcome [1] 333292 0
Any change observed in the percentage correct production (PCP) in picture description tasks (picture criterion-referenced probes) for the trained grammar target
Timepoint [1] 333292 0
This primary outcome data will be collected FIVE TIMES AT THE BASELINE PERIOD OVER 5 WEEKS and 6-8 times during the 5 week intervention and 3 times the first, third and sixth week after intervention ends,
Primary outcome [2] 333345 0
Any change observed in the percentage correct production (PCP) in picture description tasks (picture probes) for the untrained grammar item
Timepoint [2] 333345 0
This primary outcome data will be collected FIVE times at the baseline phase OVER 5 WEEKS and 6-8 times during the 5 week intervention and 3 times the first, third and sixth week after intervention ends. This change was made relative to the second round of recruitment prior to recruitment announcement
Primary outcome [3] 333346 0
Any change observed in the percentage correct production (PCP) in picture description tasks (picture probes) for the generalization grammar item
Timepoint [3] 333346 0
This primary outcome data will be collected FIVE times at the baseline phase OVER FIVE WEEKS and 6-8 times during the 5 week intervention and 3 times the first, third and sixth week after intervention ends. This change is made prior to the second round of announcement prior to enrolment commencement
Secondary outcome [1] 416518 0
Any change in the Percent Correct Production observed on the trained grammar target in the treatment sessions
Timepoint [1] 416518 0
the first secondary outcome data will be collected in every 1 of the 16 therapy sessions
Secondary outcome [2] 416519 0
Change in the number of correct productions of the trained grammar target in structured conversation tasks (conversation probes)
Timepoint [2] 416519 0
the second secondary outcome data will be collected in the second baseline session, the second and the second last therapy sessions and the last 2 post therapy maintenance sessions at the third and sixth week after intervention ends
Secondary outcome [3] 416687 0
Change in the The FOCUS-34 questionnaire (Thomas-Stonell et al., 2013) assessing communication participant. It is to be completed by the parent(s) of the participating children
Timepoint [3] 416687 0
It will be obtained at the first baseline and the last post therapy maintenance session
Secondary outcome [4] 416861 0
Change in the number of correct productions of the generalization grammar item in structured conversation tasks (conversation probes)
Timepoint [4] 416861 0
the second secondary outcome data will be collected in the second baseline session, the second and the second last therapy sessions and the last 2 post therapy maintenance sessions at the third and sixth week after intervention ends

Eligibility
Key inclusion criteria
Inclusion Criteria
1. Aged aged 5 years 0 months to 7 years 11 months at time of the baseline probe.
2. Confirmed diagnosis of developmental language disorder (DLD) using the criteria operationalised in Bishop et al. (2017), including
a. Performance below the diagnostic cut-off in one or more standardised norm-referenced language tests
b. Normal hearing
c. No earlier diagnosis, parental or teacher concern of intellectual disability, or autism spectrum disorder
d. Parental and/or teacher concern of language difficulties and their impact on the child’s learning and psychosocial development
3. English as primary language of the child
4. Speech is at least 80% intelligible to the speech-language pathologist unfamiliar to the child
5. Normal vision with or without eyeglasses
Minimum age
5 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
1. Concomitant genetic or neurodevelopmental disorder e.g., autism, global developmental delay
2. A home language other than English
3. Performance on the baseline measures before treatment show a significant upward trend

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 design features
single subject experimental design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
visual analysis, Tau-Corrected Baseline--a measure of effect size

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
1/04/2023
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
10
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 39116 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 312803 0
University
Name [1] 312803 0
University of Sydney--start up fund for new employee
Country [1] 312803 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
faculty of medicine and health
Susan Wakil Health Building
Western Avenue
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 314445 0
None
Name [1] 314445 0
Nil
Address [1] 314445 0
Nil
Country [1] 314445 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312088 0
University of Sydney HREC
Ethics committee address [1] 312088 0
Ethics committee country [1] 312088 0
Australia
Date submitted for ethics approval [1] 312088 0
06/12/2022
Approval date [1] 312088 0
16/03/2023
Ethics approval number [1] 312088 0

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

Contacts
Principal investigator
Name 123430 0
A/Prof Mei-Yin Anita Wong
Address 123430 0
University of Sydney
Faculty of Medicine and Health
level 7
Susan Wakil Health Building
Western Avenue
The University of Sydney
Camperdown NSW 2006
Country 123430 0
Australia
Phone 123430 0
+61432798908
Fax 123430 0
Email 123430 0
[email protected]
Contact person for public queries
Name 123431 0
Anita Wong
Address 123431 0
University of Sydney
Faculty of Medicine and Health
level 7
Susan Wakil Health Building
Western Avenue
The University of Sydney
Camperdown NSW 2006
Country 123431 0
Australia
Phone 123431 0
+61 293519168
Fax 123431 0
Email 123431 0
[email protected]
Contact person for scientific queries
Name 123432 0
Anita Wong
Address 123432 0
University of Sydney
Faculty of Medicine and Health
level 7
Susan Wakil Health Building
Western Avenue
The University of Sydney
Camperdown NSW 2006
Country 123432 0
Australia
Phone 123432 0
+6191142199
Fax 123432 0
Email 123432 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


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.