Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000744853
Ethics application status
Approved
Date submitted
12/07/2012
Date registered
12/07/2012
Date last updated
13/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised control trial of two different speech therapy approaches (Rapid Syllable Transition Treatment and Nuffield Dyspraxia Programme 3rd edition) to treating Childhood Apraxia of Speech.
Scientific title
For 4-12 year old children with Childhood Apraxia of Speech does the Rapid Syllable Transition Treatment or the Nuffield Dyspraxia Programme (3rd edition) provide greater treatment and/or generalisation gains up to 4 months post treatment?
Secondary ID [1] 280828 0
Nil
Universal Trial Number (UTN)
U1111-1132-5952
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Apraxia of Speech 286900 0
Condition category
Condition code
Neurological 287221 287221 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 287231 287231 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rapid Syllable Transition Treatment (ReST) - is a complexity based speech therapy approach for children with Childhood Apraxia of Speech. It is based on current Principles of Motor Learning with the intention of maximising long-term maintenance and generalisation of skills.

ReST has Phase I / II research evidence (e.g. Ballard, Robin, McCabe & McDonald, 2010).
Treatment dose: 1 hour individual therapy sessions, 4 days a week for 3 weeks. Each session will include 100-120 production trials to ensure consistent practice across treatments.
Intervention code [1] 285254 0
Treatment: Other
Comparator / control treatment
Nuffield Dyspraxia Programme - Third Edition (NDP3) - is a comprehensive treatment package that has been utilised in clinical practice for approximately 30 years since the release of the first edition. The programme aims to improve articulation, voice, resonance and in later levels of the hierarchy morphology, syntax and prosody. The program is hierarchical (bottom-up). The programme works on the next level of skills needed and with frequent, systematic practice moves onto more complex levels.

NDP3 has Phase I / II research evidence (e.g. Teal, 2006; Lundeborg & McAllister, 2007)
Treatment dose: 1 hour inidivual therapy sessions, 4 days a week for 3 weeks (same as ReST treatment). Each session will include 100-120 production trials to ensure consistent practice across treatments.
Control group
Active

Outcomes
Primary outcome [1] 287501 0
Articulation accuracy on a 292 item probe
Timepoint [1] 287501 0
Pre treatment
1 week post treatment
1 month post treatment
4 months post treatment
Primary outcome [2] 287502 0
Prosodic accuracy on a 292 item probe
Timepoint [2] 287502 0
Pre treatment
1 week post treatment
1 month post treatment
4 months post treatment
Secondary outcome [1] 298294 0
Percentage of lexical inconsistency assessed using the DEAP inconsistency subtest (Dodd et al, 2002)
Timepoint [1] 298294 0
Pre treatment
1 week post treatment
1 month post treatment
4 months post treatment

Eligibility
Key inclusion criteria
a) clinical diagnosis of suspected Childhood Apraxia of Speech (CAS),
b) between 4 and 12 years of age,
c) comprehension skills within 1 SD of the mean for a child’s chronological age (based on normative data for the receptive language score from the Clinical Evaluation of Language Fundamentals (CELF) - Fourth edition or CELF Preschool - Second edition (Semel et al, 2006),
d) normal or adjusted-to-normal hearing and vision,
e) the child and at least one parent as native Australian English speakers, and
f) no other diagnosed developmental / genetic disorders.
Minimum age
4 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285621 0
University
Name [1] 285621 0
Douglas and Lola Douglas Scholarship on Child and Adolescent Health through the University of Sydney
Country [1] 285621 0
Australia
Primary sponsor type
Individual
Name
Elizabeth Murray
Address
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 284454 0
Individual
Name [1] 284454 0
Dr. Patricia McCabe
Address [1] 284454 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country [1] 284454 0
Australia
Other collaborator category [1] 276929 0
Individual
Name [1] 276929 0
Associate Professor Kirrie Ballard
Address [1] 276929 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country [1] 276929 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287620 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 287620 0
Office of Ethics Administration
Level 6
Jane Foss Russell Building (G02)
The University of Sydney NSW 2006
Ethics committee country [1] 287620 0
Australia
Date submitted for ethics approval [1] 287620 0
Approval date [1] 287620 0
13/07/2010
Ethics approval number [1] 287620 0
12924

Summary
Brief summary
Childhood Apraxia of Speech (CAS) is a motor speech disorder. Children with CAS have difficulties planning the movements required for speech sounds and melody. The difficulties associated with CAS often persist through life and are deterimental to academic, social and vocational development, despite normal intelligence. Currently a number of single case designs are available yet few treatments have been tested or replicated.

We intend to complete the first randomised control trial to compare two treatments for CAS. The speech therapy treatments we want to compare are 1) the Rapid Syllable Transition Treatment (Ballard et al, 2010) and 2) the Nuffield Dyspraxia Programme (3rd edition) (Williams & Stephens, 2004). Both treatments have preliminary promising evidence.

We want to know if these treatments improve speech sounds and melody in children with CAS age 4-12 years. We also want to know which treatment will make better gains in treated sounds/words/sentences AND untreated but similar sounds/words/sentences.
Trial website
http://sydney.edu.au/health_sciences/speech_pathology/research/current_research.shtml#apraxia
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34427 0
Address 34427 0
Country 34427 0
Phone 34427 0
Fax 34427 0
Email 34427 0
Contact person for public queries
Name 17674 0
Elizabeth Murray
Address 17674 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 17674 0
Australia
Phone 17674 0
+61 2 9351 9334
Fax 17674 0
Email 17674 0
[email protected]
Contact person for scientific queries
Name 8602 0
Elizabeth Murray
Address 8602 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 8602 0
Australia
Phone 8602 0
+61 2 9351 9334
Fax 8602 0
Email 8602 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.