Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000695505
Ethics application status
Approved
Date submitted
8/06/2015
Date registered
3/07/2015
Date last updated
30/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment for Children with Childhood Apraxia of Speech
Scientific title
Will children with Childhood Apraxia of Speech benefit from the Kaufman Speech to Language Protocol to improve speech outcomes.
Secondary ID [1] 286823 0
Nil known
Universal Trial Number (UTN)
U1111-1170-7253
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Apraxia of Speech 295201 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295451 295451 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research will use a single case experimental design with multiple baselines across behaviours and participants. Each child will participate in initial baseline data collection, 3 weeks of individualized and targeted one-on-one treatment using the Kaufman Speech to Language protocol (K-SLP), followed by post treatment maintenance follow up. Initial baselines will comprise of between 3-5 data points randomly assigned to participants to allow for stability in measurement and to determine any clear visual trends before commencement of treatment, and to ensure stable speech production. The data to be collected includes the participant’s production of a predetermined and individualised set of words: including treated words (words that are used during the treatment session), control words (words that are untreated and do not have the same features as treatment words) and foil words (have similar features as the treated words but are untreated). This phase will be conducted in the clinic.

Treatment phase: During the treatment phase, a trained clinician (speech pathologist/trained speech pathology student) will administer treatment as per the K-SLP protocol in the clinic for 60 minutes per day 4 times/week for 3 weeks. Treatment 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. Additional data points will be collected every 4th treatment session using the predetermined individualised word lists comprised of words that are part of the participant’s treatment set, and words that are not treated. Final post-treatment assessments will be conducted at 1-week post treatment, 2 weeks and 3 months post treatment.
Intervention code [1] 291982 0
Treatment: Other
Comparator / control treatment
This research will use a single case experimental design with multiple baselines across behaviours and participants. The experimental design will be repeated on 8 participants.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295180 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.
Timepoint [1] 295180 0
1 week, 1 month and 3 month time points post treatment.
Secondary outcome [1] 314962 0
Speech accuracy as evaluated by Goldman Fristoe Test of Articulation- 2nd edition, T-POT, connected speech sample.
Timepoint [1] 314962 0
1 week, 1 month and 3 months post treatment
Secondary outcome [2] 315392 0
Percent of correct phonemes (PCC) as evaluated by Goldman Fristoe Test of Articulation- 2nd edition, T-POT, connected speech sample.
Timepoint [2] 315392 0
1 week, 1 month and 3 months post treatment.
Secondary outcome [3] 315393 0
Inventory of sounds as evaluated by Goldman Fristoe Test of Articulation- 2nd edition, T-POT, connected speech sample.
Timepoint [3] 315393 0
1 week, 1 month and 3 months post treatment

Eligibility
Key inclusion criteria
Diagnosis of Childhood Apraxia of Speech
3-5 years of age
Normal vision (adjusted to normal eg. wears glasses)
Normal hearing acuity
Child must speak English as primary language.
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
Autism Spectrum Disorder
Known neurological deficits
Intellectual impairment
Structural/oral motor anomalies

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)
The research will be advertised by the following peak organizations to forward to their members as per policy documents: SPA, CASANA. The research will also be advertised on the University of Sydney webpage, on social media (eg. Twitter and Facebook), and within the speech pathology clinic at the university. Researcher Gomez will also contact previous participants, who agreed to be contacted about further research, via email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This research will use a single case experimental design with multiple baselines across behaviours and participants (Byiers, Reichle, & Symons, 2012; Kratochwill & Levin, 2010; ). This will enable a reduplication of the basic ABA phase single subject design to allow for greater internal and external validity (Byiers et al., 2012; McReynolds & Thompson). According to Tate et al., 2013, at least 3 replications of the single case experimental design is desirable for greater internal and external validity. This research will be replicated across 8 participants.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
8/07/2015
Actual
16/07/2015
Date of last participant enrolment
Anticipated
31/05/2018
Actual
18/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9735 0
2141 - Lidcombe

Funding & Sponsors
Funding source category [1] 291368 0
Self funded/Unfunded
Name [1] 291368 0
Country [1] 291368 0
Primary sponsor type
Individual
Name
Mirjana Gomez
Address
Speech Pathology
Faculty of Health Sciences
The University of Sydney
75 East Street
Lidcombe, NSW 2141
Country
Australia
Secondary sponsor category [1] 290046 0
None
Name [1] 290046 0
Address [1] 290046 0
Country [1] 290046 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292926 0
The University of Sydney Ethics Committee
Ethics committee address [1] 292926 0
Ethics committee country [1] 292926 0
Australia
Date submitted for ethics approval [1] 292926 0
13/04/2015
Approval date [1] 292926 0
22/06/2015
Ethics approval number [1] 292926 0
2015/361

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

Contacts
Principal investigator
Name 57658 0
A/Prof Patricia McCabe
Address 57658 0
Speech Pathology
Faculty of Health Sciences
The University of Sydney
75 East Street
Lidcombe, NSW 2141, Australia
Country 57658 0
Australia
Phone 57658 0
+61 (02) 93519747
Fax 57658 0
Email 57658 0
[email protected]
Contact person for public queries
Name 57659 0
Mirjana Gomez
Address 57659 0
Speech Pathology
Faculty of Health Sciences
The University of Sydney
75 East Street
Lidcombe, NSW 2141, Australia
Country 57659 0
Australia
Phone 57659 0
+61 (02) 93519747
Fax 57659 0
Email 57659 0
[email protected]
Contact person for scientific queries
Name 57660 0
Mirjana Gomez
Address 57660 0
Speech Pathology
Faculty of Health Sciences
The University of Sydney
75 East Street
Lidcombe, NSW 2141, Australia
Country 57660 0
Australia
Phone 57660 0
+61 (02) 93519747
Fax 57660 0
Email 57660 0
[email protected]

No information has been provided regarding IPD availability


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.