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Trial registered on ANZCTR


Registration number
ACTRN12615000849594
Ethics application status
Not yet submitted
Date submitted
31/07/2015
Date registered
14/08/2015
Date last updated
14/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized control trial comparing ultrasound visual feedback and ReST (Rapid Syllable Transition Training) to improve speech in childhood apraxia of speech (CAS).
Scientific title
In children aged 7-16 years old with apraxia of speech, how does ReST compare to Ultrasound treatment to improve articulation and prosody.
Secondary ID [1] 287188 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Apraxia of Speech/ verbal dyspraxia 295762 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296043 296043 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All children will receive treatment 2 days per week for 6 weeks for a total of 12 sessions. Each session will be 1 hour in duration.

ReST Treatment Protocol
Stimuli: ReST uses multi-syllable nonword stimuli that include varied consonants and vowels (C, V). Three C sounds are selected from each child’s impaired sounds, plus 3 Vs. All possible CV units for the 6 sounds are randomly combined to form 40 strings, half with strong-weak (SW) stress and half weak-strong (WS) stress (e.g. KAdiku, biTUga), presented orthographically. A random selection of 50% of the stimuli will be treated and 50% will be tested for treatment generalization. Children unable to read the stimuli are given spoken models for imitation until independent production emerges (Ballard et al, 2010). No statistical difference in treatment outcome has been noted between imitation and reading (McCabe et al, 2014). To test ecological validity, 20 real words (same length and sounds as treated items, e.g. toboggan) are tested with naming in a 100-utterance speech sample.

Individual treatment sessions conducted by one of a pool of SPs will include 10 minute pre-practice and 50 minute practice in accordance with principles of motor learning (PML) in ReST (Ballard et al, 2010). Pre-practice: Using 10 randomly selected stimuli, the clinician defines parameters of a correct response and guides the child through attempts at reading stimuli aloud or imitating a clinician model, with cues on articulatory accuracy and stress, with 100% feedback on performance. When the child achieves 5 correct productions with the guided cueing, or 10 minutes has elapsed, the session moves on to practice. Practice: 100 trials of reading aloud or imitating production of randomly selected treatment stimuli. Feedback on correctness is provided for 50% of randomly selected trials. Children randomised to ReST will receive 1 hour treatment per day for 2 days per week for 6 weeks, a total dose of 1200 practice trials at half the intensity of the completed RCT (Murray, McCabe & Ballard, 2012)(ANZCTR: ACTRN12612000744853). The completed trial delivered treatment for 1 hour sessions, 4 times per week for 3 weeks.

Ultrasound Treatment Protocol
Ultrasound biofeedback involves training articulatory patterns using real-time visual displays of
the tongue. Based on our previous work in the ultrasound biofeedback program, both in CAS and in Residual Speech Sound Errors, each child will have 4 target sequences available for treatment (CV, VC, or CC), although each session will be structured to address only two of those sequences; thus the target sequences will be cycled through in pairs (target sequence 1 and 2 treated for two sessions, followed by target sequence 3 and 4 treated for two sessions). Individual treatment sessions will be conducted by SPs for 60 minutes. Within the session, 10 minutes of pre-practice with the ultrasound will be provided to allow the clinician to instruct the client in the visual patterns associated with the two desired sequences. This will be followed by 50 minutes of structured practice, broken down into four 12-minute time blocks. These time blocks will alternate, allowing practice with the ultrasound in Time Block A, followed by practice without the ultrasound (i.e., generalization) in Time Block B, ultrasound in Time Block C, and finishing with no ultrasound training in Time Block D. A timer will be used to ensure adherence to this structure.
Practice items will begin with the target sequence in isolation (CV, VC, or in the case of a CC target this will be paired with a vowel e.g. CCV), but complexity will increase based on performance (from syllables to monosyllabic words, multisyllabic words, phrases, and sentences). Six trials will be attempted in a block, and advancement to more complex items with the same target sequence will be contingent upon achieving at least 5 of 6 trials correct in the block (i.e., “step up”). Achieving 1 or 0 correct items will mean that the next practice attempt on that target sequence will “step down” to a simpler level of linguistic complexity. If the participant does not successfully “step up” to advance to more complex stimuli, then the next practice block will commence on the other treatment target sequence. Hence, practice will involve alternating between the two treatment targets throughout the session as a way to incorporate practice variability.
Within each block, the amount of feedback (knowledge of performance and knowledge of results) will be dependent upon the level of complexity that the child is attempting. Higher frequency feedback with more knowledge of performance (KP) will be provided in blocks targeting simpler linguistic items, and lower frequency feedback with less KP will be used in blocks addressing more complex items. For example:
Syllable level: 4/6 trials receive KP+KR (knowledge of results) feedback
Monosyllabic word level: 3/6 trials receive KP+KR feedback, 1 receives KR feedback only
Multisyllabic word level: 2/6 trials receive KP+KR feedback, 2 receive KR feedback only
Phrase level: 1/6 trials receive KP+KR feedback, 2 trials receive KR feedback only
Sentence level: 1/6 trials receive KP+KR feedback, 1 trial receive KR feedback only.

Participants' parent/carers in both groups will sign a consent form with child participants providing written assent. The Participant Information Statement (PIS) details 2 weekly treatment sessions are required and 3 follow-up sessions. Researchers will monitor participant attendance and reschedule missed appointments for the near future. No other strategies to monitor adherence is required. In our Australian studies to date, only 2 participants of 54 recruited did not finish, due to parental inability to manage transport (Murray et al., 2012 & Thomas, McCabe & Ballard, 2014). Attrition will be addressed through intention to treat analysis. We are the only group in Australia studying CAS intervention. We receive >50 referrals/year to our Sydney treatment research lab. Hence recruitment of the required participants is feasible and strengthened by our well-established networks with peak bodies, community SP clinics, and CAS communities.
Intervention code [1] 292466 0
Treatment: Other
Intervention code [2] 292467 0
Behaviour
Comparator / control treatment
ReST treatment is closest to the control as it has previously been studied in an RCT.
Control group
Active

Outcomes
Primary outcome [1] 295710 0
Pre-treatment and post-treatment comparison of sentence level accuracy for percentage of phonemes correct. This outcome will be assessed 7 times before, during and after treatment through a sentence imitation task designed to assess phoneme accuracy in sentences of various lengths. Sentence targets will be recorded and embedded in PowerPoint slides for the participant to repeat. The probe list will be designed by researchers and will include varied consonants, vowels, word shapes and stress and sentences.
Timepoint [1] 295710 0
1 week before treatment starts, at 1st , 5th, 9th treatment session and 1 week, 4 weeks and 3 months after final treatment session.
Primary outcome [2] 295711 0
Pre-treatment and post-treatment comparison of sentence level accuracy for prosodic accuracy with words. This outcome will be assessed 7 times before, during and after treatment through a sentence imitation task designed to assess prosodic accuracy in sentences with multi-syllable words of various length and stress patterns. Sentence targets will be recorded and embedded in PowerPoint slides for the participant to repeat. Probes will be administered by independent clinician. The probe will be designed by researchers and will include varied consonants, vowels, word shapes and stress and sentences.
Timepoint [2] 295711 0
1 week before treatment starts, at 1st , 5th, 9th treatment session and 1 week, 4 weeks and 3 months after final treatment session.
Primary outcome [3] 295712 0
Change over time in target consonants and vowels correct for ultrasound biofeedback condition. To be assessed 7 times before, during and after treatment through a sentence imitation task designed to assess phoneme accuracy in sentences of various lengths. Consonant and vowel targets for participants receiving ultrasound therapy will be measured through single word elicitation tasks and sentence imitation tasks. Sentences will be recorded and embedded in PowerPoint slides for the participant to repeat. Probes will be administered by independent clinician. The probe will be designed by researchers and will include varied consonants, vowels, word shapes and stress and sentences.
Timepoint [3] 295712 0
1 week before treatment starts, at 1st , 5th, 9th treatment session and 1 week, 4 weeks and 3 months after final treatment session.
Secondary outcome [1] 316534 0
Primary Outcome: Change over time in treated nonwords correct for both phonemes and lexical stress in the ReST condition. Results will be drawn from the seven probes delivered via Powerpoint slide and administered by independent clinician. The probe will be designed by researchers and will include varied consonants, vowels, word shapes and stress and sentences.
Timepoint [1] 316534 0
1 week before treatment starts, at 1st , 5th, 9th treatment session and 1 week, 4 weeks and 3 months after final treatment session.
Secondary outcome [2] 316535 0
Primary Outcome: Percent consonants correct (PCC) and prosodic accuracy comparison between immediate post-treatment probe and at three month follow-up assessment. This outcome will be a comparison between PCC and prosodic accuracy with measurements taken from single word and sentence imitations tasks. Probes will be administered by independent clinician. The probe will be designed by researchers and will include varied consonants, vowels, word shapes and stress and sentences.
Timepoint [2] 316535 0
Post-treatment probe 1 week after therapy and 3 month post-treatment probe.
Secondary outcome [3] 316536 0
To examine treatment responders/non-responders in both interventions. Qualitative analysis will be conducted to examine treatment responders/non-responders in both interventions. Although our sample sizes will be limited, we will use the current data to explore whether there are pre-treatment profiles that indicate which children respond well within each intervention. Future studies could then be devised to plan around pairing children to the approach that is most appropriate for their profile.
Timepoint [3] 316536 0
Seven probes from before, during and after treatment will be administered using the same list of targets.
Secondary outcome [4] 316537 0
To establish an effect size which can be used for subsequent larger trials. The current study is designed to be a preliminary investigation that could lead to future funding. Pending the results, effect sizes observed here can be used to drive power calculations for future larger-scale studies that may involve variations on the implementation of the procedures for these approaches.
Timepoint [4] 316537 0
Effect size calculated after all treatment and probes have been conducted. Statistical analysis (ANCOVA) will analysis between group differences.

Eligibility
Key inclusion criteria
Children who meet the following criteria will be included:
1. diagnosis of CAS through consensus over 2 expert judges
2. 7-16 years old
3. no other motor speech disorder (i.e. dysarthria) or structural deficit (e.g. cleft palate)
4. nonverbal intelligence, receptive language and oral-facial exam within normal range
5. normal (corrected to normal) hearing and vision
6. no other developmental or genetic diagnosis
7. Australian English as first and primary language
Minimum age
7 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous participation in ReST treatment research in since 1st January 2013.

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)
Initial contact will be made by via flyers in a clinic waiting room or an email from administrative staff at the University’s Communication Disorders Treatment and Research Clinic (CDTRC).
*The flyer will be placed in the waiting room of the Communication Disorders Treatment and Research Clinic once ethics approval is granted.
*The email, with the flyer attached, will be sent to Speech Pathology contacts of the Speech Pathology Discipline and the Communication Disorders Treatment and Research at The University of Sydney on one occasion only after approval from the ethics committee.
*The email to previous research participants will be sent once.

Only previous participants who have given written consent for information about future research will be emailed the flyer. People on the Speech Pathology/ CDTRC mailing list have given their email address for information about activities of the clinic including upcoming research. Participants will be advised to notify the discipline/ clinic if they no longer wish to be on the mailing list.

Initial emails about the research will be sent to participants who are in possible unequal relationships with the Chief Investigator by the Project Manager Pippa Evans who has no relationship with them and will answer their queries.

Potential participants will be screened for eligibility over the phone or by email. Parents/carers will be asked questions to ascertain whether children meet the eligibility criteria. They will be emailed the Participant Information Statement. If they are able to attend all assessment, therapy and probes, an initial assessment appointment will be booked. Once parent consent and child consent/assent has been given and all inclusion criteria have been met, concealed allocation will take place. Children will be allocated to one of two groups by an independent researcher/administrative assistant using online randomisation tool 'Sealed Envelope' (https://www.sealedenvelope.com/simple-randomiser/v1/lists).

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children will be allocated to one of two groups by an independent researcher/administrative assistant using online randomisation tool 'Sealed Envelope' (https://www.sealedenvelope.com/simple-randomiser/v1/lists).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Not all participants will receive therapy at the same time due to reduced clinician and student-clinician availability. 8-10 participants will be given treatment in the first wave with the remaining participants being treated in the second wave. As such, the study is a two arm small RCT. It presents a pilot examination of the comparison between the treatments.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
*ANOVA for significant differences. For statistically significant comparisons, Cohen's d effect sizes will be calculated.
*ANCOVA for between group changes for percent phonemes correct (PPC) and prosodic accuracy.
*Intention-to-treat analysis for withdrawals.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/08/2015
Actual
Date of last participant enrolment
Anticipated
16/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291752 0
Charities/Societies/Foundations
Name [1] 291752 0
CASANA (The Childhhood Apraxia of Speech Association of North America)
Country [1] 291752 0
United States of America
Primary sponsor type
University
Name
University of Sydney
Address
Faculty of Health Sciences, University of Sydney
75 East Street, Lidcombe
NSW 2141
Country
Australia
Secondary sponsor category [1] 290423 0
Charities/Societies/Foundations
Name [1] 290423 0
CASANA
Address [1] 290423 0
416 Lincoln Avenue 2nd Fl., Pittsburgh, PA 15209
Country [1] 290423 0
United States of America
Other collaborator category [1] 278568 0
Individual
Name [1] 278568 0
Jonathan Preston, Syracuse University
Address [1] 278568 0
Syracuse University
Syracuse, NY 13244
Country [1] 278568 0
United States of America

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293273 0
HREC University of Sydney
Ethics committee address [1] 293273 0
Ethics committee country [1] 293273 0
Australia
Date submitted for ethics approval [1] 293273 0
31/07/2015
Approval date [1] 293273 0
Ethics approval number [1] 293273 0
2015/516

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 535 535 0 0
/AnzctrAttachments/369015-PE_ReSTvUB Protocol_v2.pdf

Contacts
Principal investigator
Name 59118 0
Dr Tricia McCabe
Address 59118 0
Speech Pathology
Building C43S, Room S153
Cumberland Campus
The University of Sydney
NSW 2006
Country 59118 0
Australia
Phone 59118 0
+61 2 9351 9747
Fax 59118 0
Email 59118 0
[email protected]
Contact person for public queries
Name 59119 0
Pippa Evans
Address 59119 0
Building C43S, Room S142
Cumberland Campus
The University of Sydney
NSW 2006
Country 59119 0
Australia
Phone 59119 0
+61 2 9351 9713
Fax 59119 0
Email 59119 0
[email protected]
Contact person for scientific queries
Name 59120 0
Tricia McCabe
Address 59120 0
Speech Pathology
Building C43S, Room S153
Cumberland Campus
The University of Sydney
NSW 2006
Country 59120 0
Australia
Phone 59120 0
+61 2 9351 9747
Fax 59120 0
Email 59120 0
[email protected]

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