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Trial registered on ANZCTR


Registration number
ACTRN12621001698864
Ethics application status
Approved
Date submitted
24/11/2021
Date registered
10/12/2021
Date last updated
15/11/2022
Date data sharing statement initially provided
10/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of Rapid Syllable Transition Treatment in improving communication in children with cerebral palsy: A randomized controlled study
Scientific title
The effectiveness of Rapid Syllable Transition Treatment in improving communication in children with cerebral palsy: A randomized controlled study
Secondary ID [1] 302611 0
NIL
Universal Trial Number (UTN)
U1111-1260-0960
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 319498 0
Condition category
Condition code
Neurological 317471 317471 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adherence to the intervention will be monitored in the following way:
The speech pathology students will receive training in the ReST protocol by the speech pathologist.The speech pathologist and the students will receive supervision and do joint sessions until the student is considered proficient to deliver the intervention.
Treatment fidelity will be checked by the students and the speech pathologists from 20 % of randomly selected intervention videos against the accuracy of feedback and the timing of feedback.
The study treatment is The Rapid Syllable Transition treatment
The Rapid Syllable Transition Treatment (ReST; McCabe et al., 2017) is a motor speech intervention. It involves the use of multisyllabic pseudowords to improve the ability to transition rapidly and fluently from one sound/syllable to the next, and control of the melody in the form of relative emphasis, or stress, placed on each syllable within a word (McCabe et al., 2017). The speech pathologist uses games and other age-appropriate reinforcers to elicit the child to repeat the targeted pseudo words.
The session includes a pre -practice phase during which the child practices saying the target sounds. This is followed by a practice phase during which the child repeats 100 pseudo words in total. The practice phase includes a break after 20 repetitions when the child is free to play a game of their choice.
The therapy is delivered by a speech pathologist or a speech pathology student under the supervision of a speech pathologist.
Therapy will be delivered individually via teleconference or face to face. A parent/ carer will also attend the sessions.
Therapy will be delivered three times a week for six weeks. Each session will take 45 minutes.
The location will be either teleconference, The University of Sydney on-campus speech pathology clinic, the child’s home or school, or any combination of these.
Intervention code [1] 318897 0
Treatment: Other
Comparator / control treatment
The control to ReST group is the usual care group. The usual care group begins ReST once the T3 assessments (three weeks post intervention) have been completed.
Usual care consists of any speech therapy services the participant might be receiving during the duration of 6 weeks. If the participant does not get any therapy, that is also considered usual care.
Control group
Active

Outcomes
Primary outcome [1] 325495 0
The primary outcome is speech intelligibility. This is measured with:
The Intelligibility in Context scale (ICS; McLeod et al., 2012). ICS is an assessment to rate the intelligibility of children’s speech.
Timepoint [1] 325495 0
Baseline - T1
Within one week post ReST - T2
Three weeks post ReST - T3
Within one week post usual care group intervention - T4
Three weeks post usual care group intervention -T5
Primary outcome [2] 325501 0
speech intelligibility. This is measured with:
The Word Intelligibility by Picture Identification (WIPI; Ross and Lerman, 1970) WIPI assess the intelligibility of children’s speech at single word level
Timepoint [2] 325501 0
Baseline - T1
Within one week post ReST - T2
Three weeks post ReST - T3
Within one week post usual care group intervention - T4
Three weeks post usual care group intervention -T5
Secondary outcome [1] 388198 0
Communicative participation - This is measured with:
Focus On Communication Under Six assessment (FOCUS; Thomas-Stonell, et al., 2004). FOCUS is an assessment for parents to rate their perception of their child’s communicative participation and confidence in everyday situations.
Timepoint [1] 388198 0
Baseline - T1
Within one week post ReST - T2
Within one week post usual care group intervention - T4
Secondary outcome [2] 388199 0
Communicative participation - This is measured with:
Speech Participation and Activity Assessment of Children (SPAAC; McLeod, 2004). SPAAC is child directed rating tool of participation levels for children with speech disorders.
Timepoint [2] 388199 0
Baseline - T1
Within one week post ReST - T2
Within one week post usual care group intervention - T4
Secondary outcome [3] 388200 0
Parent/ Carer and child satisfaction in their child’s communicative participation. These are measured with:The Canadian Occupation Performance Measure (Law, et al., 2005). COPM is an assessment for participants to set intervention goals and to rate performance skill and satisfaction.
Timepoint [3] 388200 0
Baseline - T1
Within one week post ReST - T2
Within one week post usual care group intervention - T4
Secondary outcome [4] 388201 0
Speech accuracy. This is measured with:
Percentage of phonemes correct in word level. The percentage of phonemes correct (PPC) expresses the percentage of consonant sounds that are articulated correctly. It is considered a robust means of assessing articulation accuracy (Shriberg et al., 1997)
Timepoint [4] 388201 0
Baseline - T1
Within one week post ReST - T2
Three weeks post ReST - T3
Within one week post usual care group intervention - T4
Three weeks post usual care group intervention -T5
Secondary outcome [5] 389130 0
Sentence complexity. - This is measured with:
Mean length of utterance (MLU) in speech. Changes in the child’s mean length of utterance, as measured by calculating the average number of morphemes in a child’s utterances (Miller & Chapman, 1981).
Timepoint [5] 389130 0
Baseline - T1
Within one week post ReST - T2
Three weeks post ReST - T3
Within one week post usual care group intervention - T4
Three weeks post usual care group intervention -T5
Secondary outcome [6] 389131 0
Sentence complexity. This is measured with:
Mean Length of Utterance with AAC. This is only applicable with children who have a speech generating device. - As with speech MLU, but the MLU is measured from sentences produced on the speech generating device.
Timepoint [6] 389131 0
Baseline - T1
Within one week post ReST - T2
Three weeks post ReST - T3
Within one week post usual care group intervention - T4
Three weeks post usual care group intervention -T5

Eligibility
Key inclusion criteria
1) Aged between 8-14 years
2) Diagnosis of CP
3) Viking Speech Scale classification II-III
4) No diagnosed intellectual disability
5) Normal or adjusted-to-normal hearing and vision
Minimum age
8 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) non-CP diagnoses or multiple diagnosis
2) Intellectual disability, such as the participant is unable to repeat words and sounds
3) Viking Speech Scale (VSS) classification I or IV. This means that the participant's speech is too good or too severely effected.
5) Hearing impairment that is not corrected, such as what impacts on hearing speech and intelligibility
6) Age younger than 8 and older than 14 years.

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)
After the Informed Consent is signed and the baseline assessment has been completed, an officer not connected with the study and at a separate location draws a concealed opaque envelope that contains the group allocation. The study coordinator is informed of the result who informs that family.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization is used with concealed opaque envelopes which contain the group to which the child is randomized.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size will be 20 children, 10 in each treatment group.
Sample size calculation:
Sample size calculator used: https://www.ai-therapy.com/psychology-statistics/sample-size-calculator)

This pilot RCT is the first to use ReST with children with CP in a randomised controlled trial. There were no previous studies of this intervention with this population using the proposed outcome measures from which sample sizes could be calculated, so studies with similar populations, treatments and measures were considered for sample size calculations.

ReST is a motor speech intervention for the treatment of childhood apraxia of speech (CAS). While it has been shown to be effective in improving speech in children with CAS, it has not been researched with children with CP.
ReST effect sizes have primarily been calculated using d2. Using this metric, Thomas (2017) reported an average ReST intervention effect size of 5.55 (SD 2.41, range 2.48–8.52). (Previously published single-case clinician-delivered ReST treatment studies reporting similar dependent measures; McCabe et al., 2014; Thomas et al., 2014; Thomas et al., 2016). Using this effect size with power of 0.8 and alpha of 0.05 the online sample size calculation produced a sample size of 3 for each group. The only other RCT using ReST in children with CAS produced an effect size (Cohen’s d) of 1.376 giving a sample size of 10 for each group.
Our exploratory pilot study on the use of ReST with children with CP indicated improvement in mean length of utterance, with an d2 effect size of 0.56. This effect size gives a sample size of 6. This was derived from calculating the effect sizes from the group means (baseline and maintenance), and standard deviation for four outcome measures. Speech MLU is a secondary outcome in the current study.
The other motor speech interventions used with children with CP include LSVT LOUD (Boliek & Fox, 2017), Speech Systems Intelligibility Treatment (Pennington et al., 2010; 2013), and PROMPT (Ward, 2012). Sample size calculations were derived from each of these studies.
LSVT LOUD: Boliek & Fox, 2017 reported a Cohen’s d effect size 0.3 for pre and post speech intelligibility measures. The sample size calculation was therefore a sample size of 52.
Speech Systems Intelligibility Treatment: Effect sizes were not reported in these studies, so they were calculated from the published study data. These were (Pennington et al., 2010) - 0.5 and (Pennington et al., 2013) 0.6 respectively. The sample size calculation based on these provided a sample sizes of 19 and 23 respectively.
PROMPT: Ward, 2012 reported a Cohen’s d effect size for four children for percentage of phonemes correct measure. A mean of these was calculated to be 1.1. The sample size calculation was therefore 7.
These sample size figures from the studies on children with CP were notably larger than those based on the ReST treatment studies. Although studies on children with CP may require a large sample size than those on children with CAS, a large sample size may be precarious at this stage as the effectiveness of ReST with children with CP is not known. In addition, the interventions in these studies differed quite significantly from ReST intervention, which may render the sample sizes improbable.
In the absence of previous comparable studies on the effectiveness of ReST in children with CP, studies with other populations using ReST, studies with CP population using different interventions, and an exploratory study on ReST with CP population were considered in sample size calculations. Based on these, and on our best estimate, we made a decision to use a sample size of six per group. This was increased to ten per group to account for potential attrition and to reflect the calculation from Murray et al., 2015.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/04/2021
Date of last participant enrolment
Anticipated
20/04/2022
Actual
20/04/2022
Date of last data collection
Anticipated
20/05/2022
Actual
20/05/2022
Sample size
Target
20
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307041 0
University
Name [1] 307041 0
The University of Sydney
Country [1] 307041 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Susan Wakil Health Building D18
Western Avenue, The University of Sydney, Camperdown, NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 307609 0
None
Name [1] 307609 0
Address [1] 307609 0
Country [1] 307609 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307168 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 307168 0
Ethics committee country [1] 307168 0
Australia
Date submitted for ethics approval [1] 307168 0
30/10/2020
Approval date [1] 307168 0
16/03/2021
Ethics approval number [1] 307168 0

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

Contacts
Principal investigator
Name 106270 0
Prof Patricia McCabe
Address 106270 0
Susan Wakil Health Building D18
Western Avenue, The University of Sydney, Camperdown, NSW 2006
Country 106270 0
Australia
Phone 106270 0
+61410245661
Fax 106270 0
Email 106270 0
tricia.mccabe@sydney.edu.au
Contact person for public queries
Name 106271 0
Patricia McCabe
Address 106271 0
Susan Wakil Health Building D18
Western Avenue, The University of Sydney, Camperdown, NSW 2006
Country 106271 0
Australia
Phone 106271 0
+61410245661
Fax 106271 0
Email 106271 0
tricia.mccabe@sydney.edu.au
Contact person for scientific queries
Name 106272 0
Patricia McCabe
Address 106272 0
Susan Wakil Health Building D18
Western Avenue, The University of Sydney, Camperdown, NSW 2006
Country 106272 0
Australia
Phone 106272 0
+61410245661
Fax 106272 0
Email 106272 0
tricia.mccabe@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data on the individual's age, sex, functional motor levels Gross Motor Function Classification Sclae (GMFCS, Communication Function Classification Scale (CFCS), The Viking Speech Scale (VSS), type of CP, associated impairment of CP, and type of speech generating data will be shared.

Data on the individual's assessment scores at each timepoint will be shared.
When will data be available (start and end dates)?
Data will be available for five years after publication .
Available to whom?
Data will be available for everyone with a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor, and the participants.
Available for what types of analyses?
Data will be available approved proposal investigating similar aims to this study and for IPD meta-analyses.
How or where can data be obtained?
Data can be obtained from the Principal Investigator via email subject to approvals by the Principal Investigator
professor Patricia McCabe
The University of Sydney
Susan Wakil Health Building D18, Western Avenue, Camperdown, NSW 2006, Australia
tricia.mccabe@sydney.edu.au


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Effectiveness of Rapid Syllable Transition Treatment in Improving Communication in Children with Cerebral Palsy: A Randomized Controlled Trial.2023https://dx.doi.org/10.1080/17518423.2023.2218485
N.B. These documents automatically identified may not have been verified by the study sponsor.