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Trial registered on ANZCTR


Registration number
ACTRN12616001446459
Ethics application status
Approved
Date submitted
25/09/2016
Date registered
17/10/2016
Date last updated
15/03/2019
Date data sharing statement initially provided
15/03/2019
Date results information initially provided
15/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Speech intervention for preschoolers with cleft palate using principles of motor learning
Scientific title
Speech intervention for preschoolers with cleft palate using principles of motor learning
Secondary ID [1] 290194 0
Nil known
Universal Trial Number (UTN)
U1111-1187-8621
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cleft palate 300345 0
speech disorder 300346 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300205 300205 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an initial study to apply speech intervention using the principles of motor learning to active and passive cleft type speech errors in preschool children aged 3-6 years. It is an alternating treatment single subject design with multiple baselines across participants and behaviours over two treatment phases.
Two treatment phases, phase I and phase II, will be conducted twice weekly for eight weeks. A 4 week maintenance phase will follow each treatment phase. A final assessment will be administered 4 weeks after the final treatment session in phase II. The total study duration will be 28 weeks.
The pre/post-treatment assessment and treatment in the study will be conducted by Certified Practising Speech Pathologists experienced in working with young children. Treatment sessions will go for 45-60 minutes. Each participant will be treated by the same speech pathologist throughout. There is no requirement for any practice outside of the twice-weekly speech therapy sessions.
Parents/carers will attend all the sessions with the participant.
Pre and post assessments and treatment will be conducted in the speech therapy clinic at: Sydney Children’s Hospital, Randwick or Communication Disorders Treatment and Research Clinic (CDTRC), The University of Sydney or the Canberra Hospital.
Therapy speech targets
A set of individualised speech targets will be selected for each participant in the study. Targets will be based on the speech sound errors identified during pre-treatment assessment using the results from the standardised assessment and the cleft speech assessment. A set of 3-6 treatment words that correspond with each selected target will be chosen as treatment items. These treatment items will be presented on picture cards that are age appropriate and engaging for the participants.
Treatment Phases
Each participant will attend two phases of twice weekly treatment sessions for eight consecutive weeks in each phase. Phase I will address either active or passive errors and will be alternated for phase II. Each treatment session will contain a pre-practice and practice component. The principles of motor learning that will be used to guide treatment are:
*Practice Amount: more practice facilitates better learning than less practice
*Practice Schedule: random practice facilitates better learning than blocked practice
*Feedback Type: knowledge of results facilitates better learning than knowledge of performance
*Feedback Frequency: reduced frequency feedback facilitates better learning than high frequency feedback
A therapy manual will be created to guide the practice and feedback of the treatment sessions and data will be collected on both the participants’ practice attempts and the feedback given by the speech pathologist.
Treatment items will be practiced during a series of age appropriate play based activities and educational games that have been carefully selected and/or designed as they directly relate to the participants’ targets and/or facilitate many productions of the treatment word. The participant will be presented with picture cards (that represent at word or phrase) and be asked to produce the words.
Pre-practice
The intention of the pre-practice component of a session is to prepare the participant for practice and is where the correct production will be taught and feedback that provides qualitative information and/or sensory information (e.g. you can feel your nose move when you say ‘mmmm’) is given to facilitate learning of the target production. This feedback is known as knowledge of performance feedback (KP) and is used in the treatment of motor speech disorders. An example of KP feedback could be ‘you said that using the back of your mouth sound’.
Practice
In the practice component of treatment, the treatment items are practiced and feedback is given.
*Practice Amount: 100-120 practice attempts at the treatment items will be achieved each session.
*Practice Schedule: Practice will be randomised and varied across treatment items to facilitate better learning and retention.
*Feedback Frequency: Feedback will be given at a reduced frequency of 60%. Feedback will be delivered with fading feedback throughout sessions and across sessions over time. Therefore, feedback will be given at 100% for the entirety of the first session but gradually reduced until it is rarely used in the final sessions, resulting in feedback being given at a reduced rate of 60% throughout the study.
*Feedback Type: Knowledge of results feedback (KR), whether a sound was right or wrong will be given in the practice.
Control and generalization probes
Single case experimental design methodology dictates that measurement of the target of intervention should be made repeatedly and frequently across all phases of the study. Therefore, a series of control and generalisation probe items will be used in baseline, follow-up and throughout treatment to calculate change in behaviour, monitor retention, learning and generalisation. Control items are a set of untreated words that are similar to the treatment words and generalisation items will include a set of words that include the untreated cleft errors (active or passive) and any untreated and unrelated developmental speech errors.
The control and generalisation probe will be administered at each baseline session, at follow-up assessment and at the beginning of every third treatment session: they will be administered at treatment sessions 3, 6, 9, 12, and 15.
The procedure to collect the probe items during baseline and treatment sessions is the same. The speech pathologist will present the child with a picture card and ask the child to name the picture, if they can not name the picture the participant will be encouraged to imitate it. The probe items will be delivered randomly.
Blinding, reliability and fidelity
All pre/post assessment, probes and treatment sessions will be video recorded. All probes will be recorded on high quality headset audio.
All blinding is important where perceptual judgement is used in measuring outcomes. All control and generalisation probes will be assessed by independent speech pathologist/s recruited from the University of Sydney, who has no prior information regarding the treatment approach, design and hypothesis, and is blinded to the participant, treatment, session and phase.
To ensure reliability of the perceptual judgement of response accuracy, inter and intra-rater reliability will be established. A randomly selected 10% of all trials across all the participants in the study will be rated by a qualified speech pathologist who is blinded to the treatment type and phase. Each speech pathologist who provides intervention will intra-rate a randomly selected 10% of the trials that they collected.
In order to ensure fidelity of the intervention, a random selection of 10% the video recordings will be randomly analysed, rated and evaluated for reliability by members of the project team.
Intervention code [1] 295949 0
Treatment: Other
Comparator / control treatment
The participant will act as their own control in this alternating treatment single subject experimental design
Control group
Active

Outcomes
Primary outcome [1] 299691 0
Percentage of treatment items produced correctly in treatment sessions
Timepoint [1] 299691 0
each treatment session
Primary outcome [2] 299692 0
Percentage of control words (similar but untreated words) produced correctly
Timepoint [2] 299692 0
Control probe, at beginning of treatment sessions 3, 6, 9, 12, and 15
Primary outcome [3] 299693 0
Percentage consonants correct on standardised speech assessment (the standardised speech assessment to be used is the Diagnostic Evaluation of Articulation and Phonology (DEAP) articulation and phonology subtests)
Timepoint [3] 299693 0
in first baseline session and at the post treatment assessment 4 weeks after completion of treatment
Secondary outcome [1] 327865 0
Presence of cleft-type errors on cleft specific speech assessment, the Great Ormond Street Speech Assessment (GOS.SP.ASS ’98) (Sell, Harding, & Grunwell, 1999)
Timepoint [1] 327865 0
in first baseline session and at the post treatment assessment 4 weeks after completion of treatment
Secondary outcome [2] 327866 0
Intelligibility measure by parents using the Intelligibility in Context Scale (ICS)
Timepoint [2] 327866 0
during first baseline session and at the post treatment assessment 4 weeks after completion of treatment
Secondary outcome [3] 327867 0
Intelligibility measure by blinded listener (a Certified Practising Speech Pathologist) based on connected speech sample using the Universal Parameters for Reporting Speech Outcomes for Individuals with Cleft Palate (Sweeney, Trost-Cardamone, & Whitehill, 2008)
Timepoint [3] 327867 0
Connected speech sample collected during baseline and at the post treatment assessment 4 weeks after completion of treatment
Secondary outcome [4] 327868 0
Acceptability measure by blinded listener (a Certified Practising Speech Pathologist) based on connected speech sample using the Universal Parameters for Reporting Speech Outcomes for Individuals with Cleft Palate (Sweeney, Trost-Cardamone, & Whitehill, 2008)
Timepoint [4] 327868 0
Connected speech sample collected at during baseline and at the post treatment assessment 4 weeks after completion of treatment

Eligibility
Key inclusion criteria
1. Non-syndromic cleft palate which has been surgically repaired
2. Evidence of at least two cleft type speech and/or resonance errors on speech pathology assessment (at least 1 passive error and at least 1 active error)
3. 3-6 years of age
4. Age appropriate comprehension skills as measured with the Preschool Language Scales – Fifth Edition (PLS-5)
5. No sensorineural hearing loss
6. English spoken at home
7. No other medically diagnosed developmental disability
Minimum age
3 Years
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of speech errors in a child that has a cleft palate that are not able to be classified as cleft type speech errors on assessment by a speech pathologist

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size for this study has been set at a minimum of 4 participants and maximum of 8. As we have 2 treatment phases (active and passive errors) and would like to demonstrate that inter-subject replication is possible, a minimum of 4 participants is required, this has been doubled due to the age of the population and to ensure adquate data is able to be collected if participants drop out due to illness or unforeseen circumstance.
Visual analysis, effect size and acoustic analysis will be conducted during this study.
Visual analysis of single-case study designs is used to determine “whether evidence of a relation between an independent variable and an outcome variable exists and the strength or magnitude of that relation.” (Kratochwill et al., 2013, p. 30) Each participant will be analysed individually to determine if there is a causal relationship between treatment effect and the intervention on 3 or more points in time. Visual analysis has traditionally been used in the analysis of single-case study data due to the absence of an agreed standard for statistical analysis, nevertheless it is argued that it should be routinely used in conjunction with other statistical measures(Tate et al., 2014). In this study, it will be combined with effect size calculations.
The effect size, a “quantity that characterizes the degree of departure from the null state, which, in this case, is the degree to which a treatment outcome differs from zero” (Beeson & Robey, 2006, p. 3) will be calculated to contrast the pre-treatment and post-treatment levels of performance to determine the gain from the treatment. Effect size will be calculated using cohen’s d. Effect size will be calculated for:
*Direct treatment effect (treatment items)
*Generalisation to untrained items (control items)
*Generalisation to connected speech (generalisation items including developmental errors)
The total number of words correct for each set of words (treatment, control and generalisation) will be used as the individual values used to calculate the effect size. These values will be provided in tabled and/or graphical format.
Acoustic analysis of pre/post treatment speech will be conducted to determine the presence or absence of acoustic change in the passive and active errors targeted. These analyses can provide insight into the mechanism of change underlying any speech modifications. Pre and post speech samples will be put through speech analysis software and routine measures of acoustic quality such as vowel length, loudness and presence of nasality will be taken. These qualitative measures will be correlated to the perception of correctness.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 6706 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 9405 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 14345 0
2031 - Randwick
Recruitment postcode(s) [2] 18105 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 294557 0
Self funded/Unfunded
Name [1] 294557 0
Leah Hanley - Postgraduate student project
Address [1] 294557 0
c/- Discipline of Speech Pathology
Faculty of Health Sciences
The University of Sydney
Lidcombe
NSW 1825
Country [1] 294557 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Health Sciences
Discipline of Speech Pathology
Lidcombe
NSW 1825
Country
Australia
Secondary sponsor category [1] 293425 0
None
Name [1] 293425 0
Address [1] 293425 0
Country [1] 293425 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296012 0
Sydney Children’s Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 296012 0
Sydney Children's Hosptial Network
Research Ethics Office
Corner Hawkesbury Road
and Hainsworth Street
Locked Bag 4001
Westmead NSW 2145
Ethics committee country [1] 296012 0
Australia
Date submitted for ethics approval [1] 296012 0
01/08/2016
Approval date [1] 296012 0
20/09/2016
Ethics approval number [1] 296012 0
HREC/16/SCHN/294

Summary
Brief summary
This is an initial study to apply speech intervention using the principles of motor learning to cleft type speech errors. Cleft palate is known to impact on speech and language development and at least 50% of children with repaired cleft palate will require speech therapy. It is an alternating treatment single subject design with multiple baselines across participants and behaviours over two treatment phases.
Two treatment phases, phase I and phase II, will be conducted twice weekly for eight weeks. A 4 week maintenance phase will follow each treatment phase. A final assessment will be administered 4 weeks after the final treatment session in phase II. The total study duration will be 28 weeks.
The speech pathology intervention will be conducted through a series of age appropriate play based activities and educational games that have been carefully selected and/or designed as they directly relate to the participants' targets and/or to facilitate many productions of the target word. The participant will be presented with picture cards (that represent a word) and be asked to produce the words. Words will be elicited in an age appropriate manner, such as through games, activities and educational play. The principles of motor learning (practice amount, practice delivery and feedback) will be used to structure and guide the therapy.
8 participants will be required for the study. Participants will be aged between the ages of 3-6 years of age, have a non-syndromic cleft palate, and have evidence of at least two cleft type speech errors (1 active and 1 passive) on assessment by a speech pathologist.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69182 0
Ms Leah Hanley
Address 69182 0
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
Lidcombe
NSW 1825
Country 69182 0
Australia
Phone 69182 0
+61405106397
Fax 69182 0
Email 69182 0
leah.hanley@sydney.edu.au
Contact person for public queries
Name 69183 0
Ms Leah Hanley
Address 69183 0
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
Lidcombe
NSW 1825
Country 69183 0
Australia
Phone 69183 0
+61405106397
Fax 69183 0
Email 69183 0
leah.hanley@sydney.edu.au
Contact person for scientific queries
Name 69184 0
Dr Alison Purcell
Address 69184 0
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
Lidcombe
NSW 1825
Country 69184 0
Australia
Phone 69184 0
+61293519335
Fax 69184 0
Email 69184 0
alison.purcell@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This was not part of the original ethics application and we do not have approval for this at this stage.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary