Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000177257
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
5/02/2018
Date last updated
10/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the Kaufman Speech to Language Protocol to standard care
Scientific title
Comparing the Kaufman Speech to Language Protocol to standard care in children with childhood apraxia of speech: A randomised controlled trial
Secondary ID [1] 293443 0
Nil known
Universal Trial Number (UTN)
U1111-1205-6660
Trial acronym
Linked study record
ANZCTR12615000695505

Health condition
Health condition(s) or problem(s) studied:
Childhood Apraxia of Speech 305616 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304839 304839 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will utilise a randomised controlled trial (cross-over) design comparing an operationalised Kaufman Speech to Language Protocol (K-SLP) to a waiting list control group who will receive standard care. Participants will be randomly allocated to either the K-SLP treatment group (consisting of one-on-one, face-to-face therapy) or the standard care waiting list control group.

Standard care first treatment group
The waiting-list control group will receive community standard care which can vary between no treatment, or up to two sessions of speech therapy per week averaged across the 12- week standard care period. The participants in the control group will then be offered therapy 3- months after the study commences for each wave of treatment. While the children are in the standard care control group, they will have 1-monthly probes administered and their private speech pathologist (if they are receiving speech therapy) will be asked to complete a weekly short questionnaire to provide information on the duration, frequency, approach and goals of the therapy the child is receiving. This will be completed using a secure online system (Qualtrics) and will take less than 2 minutes to complete. If positive treatment effects are obtained for the treatment groups in the first and second wave, the K-SLP treatment will be offered to the remaining children participating in the research who start with the standard care arm. If positive treatment effects are not obtained, the control group will be offered a CAS treatment with known evidence, the Integrated Phonological Awareness (IPA) program.

Kaufman Speech to Language (K-SLP) first treatment group
The treatment-first group will participate in baseline data collection (1 week, up to 5 probe sessions) and then receive the K-SLP treatment immediately. Treatment will comprise twelve (12) 60-minute treatment sessions (four sessions per week for three consecutive weeks), delivered by a trained clinician (speech pathologist/trained speech pathology student). Treatment words will be individualised for each child and will consist of 20 preselected treatment words. The selection of these words will be based on the chosen sounds or word features that will be the target of the treatment for each client. This will be determined based on the initial pre-test diagnostic assessments. Additionally, there will be untreated words- 20 foil words, 20 control words that will have similar features or sounds as the treatment words. Probes will be collected before, during (after every fourth treatment session), and after treatment has ceased (1-week, 1-month and 3-months post-treatment). The probes will assess the accuracy of single word production of treated and untreated words. Following the 3-month post-treatment probe, baseline data for the standard care phase will be collected (1 week, up to 5 probe sessions) and then the children will enter the 12 weeks of standard care treatment phase. During the standard care phase, data will be collected from each child's regular speech pathologist (if they receive regular private speech therapy) to summarise the treatment they are receiving, without any further intervention from the research team.
Intervention code [1] 299685 0
Treatment: Other
Comparator / control treatment
The waiting-list control group will receive community standard care (provided by the child's private speech pathologist, if he/she has one) which can vary between no treatment, or up to two sessions of speech therapy per week averaged across the 12- week standard care period. The participants in the control group will then be offered therapy 3- months after the study commences for each wave of treatment. While the children are in the standard care control group, they will have 1-monthly probes administered and their private speech pathologist (if they are receiving speech therapy) will be asked to complete a weekly short questionnaire to provide information on the duration, frequency, approach and goals of the therapy the child is receiving. This will be completed using a secure online system (Qualtrics) and will take less than 2 minutes to complete. If the child is not receiving private speech therapy, a weekly questionnaire will not be required for them.
Control group
Active

Outcomes
Primary outcome [1] 304045 0
Motor planning for speech as evaluated by the Diagnostic Evaluation of Articulation and Phonology, Goldman Fristoe Test of Articulation- 2nd edition, DEMMS, T-POT/Test of Polysyllables.
Timepoint [1] 304045 0
1-month post-treatment time point
Secondary outcome [1] 340782 0
Speech accuracy as evaluated by Goldman Fristoe Test of Articulation- 2nd edition, T-POT/Test of Polysyllables, connected speech sample.
Timepoint [1] 340782 0
1-month post-treatment time point
Secondary outcome [2] 340783 0
Percent phonemes correct (PPC) as evaluated by Goldman Fristoe Test of Articulation- 2nd edition, T-POT/Test of Polysyllables, connected speech sample, probes
Timepoint [2] 340783 0
1-week, 1-month and 3-months post-treatment time points
Secondary outcome [3] 340784 0
Inventory of sounds as evaluated by Goldman Fristoe Test of Articulation- 2nd edition, T-POT/Test of Polysyllables, connected speech sample.
Timepoint [3] 340784 0
1-week, 1-month and 3-months post-treatment time points

Eligibility
Key inclusion criteria
Diagnosis of CAS
3;0 (years;months)-5;11 years of age
Normal vision (adjusted to normal eg. wears glasses)
Normal (adjusted to normal) hearing acuity
Receptive language skills within 1.5-2 standard deviation of the mean for age and gender.
English as primary language speaker
No diagnosis of Autism Spectrum Disorder. No known neurological deficits, no intellectual impairment, no structural/oral motor anomalies.
One parent speaks English as their primary language.
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously received K-SLP treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation via sealed opaque envelopes. The assessor will not know which group the child has been allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data will be analysed using statistical methods to compare the mean accuracy between the two groups (between-subject). Additionally, within-subject comparisons will be made to determine the response to treatment for each participant. If participants withdraw from the study, intention to treat (ITT) will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2018
Actual
Date of last participant enrolment
Anticipated
21/12/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298070 0
University
Name [1] 298070 0
The University of Sydney
Country [1] 298070 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Department of Speech Pathology
Faculty of Health Sciences
The University of Sydney
75 East Street
Lidcombe, NSW 2141
Country
Australia
Secondary sponsor category [1] 297147 0
None
Name [1] 297147 0
Address [1] 297147 0
Country [1] 297147 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299086 0
The University of Sydney Human Research and Ethics Committee
Ethics committee address [1] 299086 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 299086 0
Australia
Date submitted for ethics approval [1] 299086 0
15/01/2018
Approval date [1] 299086 0
09/04/2018
Ethics approval number [1] 299086 0

Summary
Brief summary
Preliminary evidence now exists for the efficacy of the K-SLP approach. Recently, a case report was published which used a multimodal approach combining K-SLP with sign language and oral-motor therapy (Tierney, Pitterle, Kirtz, Nakhla, & Todorow, 2016). This was followed by two separate single case multiple-baseline within-subject experimental designs (SCED) on a total of 6 children (Gomez, McCabe, Purcell, & Jakielski, 2017; Gomez, McCabe, Purcell, & Jakielski, in press). The results of the two SCED studies has provided some positive results indicating feasibility and positive treatment outcomes.

This research will continue to expand the evidence base for CAS treatment by completing a pilot randomized controlled trial (RCT) comparing the K-SLP approach to standard treatment. This research may also provide insight into what comprises standard treatment for CAS. This research is important as it provides speech-language pathologists with additional external evidence to ensure that they are providing an efficacious treatment approach for CAS, in accordance with their ethical obligation as allied health professionals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79254 0
Prof Patricia McCabe
Address 79254 0
Speech Pathology
Faculty of Health Sciences
The University of Sydney
75 East Street
Lidcombe, NSW 2141, Australia
Country 79254 0
Australia
Phone 79254 0
+61 2 93519747
Fax 79254 0
Email 79254 0
tricia.mccabe@sydney.edu.au
Contact person for public queries
Name 79255 0
Ms Mirjana Gomez
Address 79255 0
Speech Pathology
Faculty of Health Sciences
The University of Sydney
75 East Street
Lidcombe, NSW 2141, Australia
Country 79255 0
Australia
Phone 79255 0
+61 411 269 611
Fax 79255 0
Email 79255 0
mgom5883@uni.sydney.edu.au
Contact person for scientific queries
Name 79256 0
Ms Mirjana Gomez
Address 79256 0
Speech Pathology
Faculty of Health Sciences
The University of Sydney
75 East Street
Lidcombe, NSW 2141, Australia
Country 79256 0
Australia
Phone 79256 0
+61 411 269 611
Fax 79256 0
Email 79256 0
mgom5883@uni.sydney.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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