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Trial registered on ANZCTR


Registration number
ACTRN12621000666820
Ethics application status
Approved
Date submitted
25/02/2021
Date registered
1/06/2021
Date last updated
28/01/2024
Date data sharing statement initially provided
1/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomized Controlled Trial comparing Dynamic Temporal and Tactile Cueing with usual care for Childhood Apraxia of Speech
Scientific title
A Randomized Controlled Trial comparing Dynamic Temporal and Tactile Cueing with usual care for Childhood Apraxia of Speech
Secondary ID [1] 302943 0
None
Universal Trial Number (UTN)
U1111-1263-0335
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Apraxia of Speech 319977 0
Condition category
Condition code
Physical Medicine / Rehabilitation 317908 317908 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION: Dynamic Therapy (Dynamic Temporal and Tactile Cueing or DTTC)

Dynamic Therapy is based on established integral stimulation techniques for speech motor learning (“look at me, listen to me, say what I say”) and involves intensive drills on a core set of meaningful but relatively simple words containing sounds that the child already can produce (e.g., “Hi daddy”) and those sounds that are emerging. Treatment words which are highly salient and frequently used are chosen with the child and their family.
In Dynamic Therapy, the clinician systematically works toward independent (non-imitated) production by fading cues in a hierarchy. Speaking rate is reduced, and the time between clinician model and child’s response is varied based on the child’s performance; tactile cues are provided as needed to demonstrate articulatory configurations. Rapid reinforcers are used to maximize the number of practice trials per session. Dynamic Therapy is flexible in providing children with severe apraxia the cues they need to acquire accurate words and phrases. It incorporates principles of motor learning, which refer to practice conditions that are thought to enhance learning (e.g., reducing feedback as the child improves; practicing the same target multiple times in a row before practicing targets in random order) (Maas et al., 2008).

MATERIALS:

Materials will include a laptop with an external microphone plus accessories, and videorecorder plus accessories (tripod, memory cards) for data collection and recording treatment sessions. Additional supplies will include standardized speech pathology behavioral tests and score forms, recruitment materials, data sheets, printing, participant costs, open access publishing, and office supplies.

WHO WILL DELIVER THE TREATMENT:

Speech Pathologists who have been trained by the research team in Dynamic Therapy will provide treatment to participants. An operationalized version of DTTC (Dynamic Therapy) co-developed with Dr. Edythe Strand will be used to train clinicians across the different clinical sites, allowing them to deliver the same therapy and allowing us to measure fidelity. This operationalized version will include a pre-practice phase to address precursors to learning.

CLINICIAN TRAINING:

Treating clinicians will complete training in Dynamic Therapy. This will include:
- Reading the tutorial article about Dynamic Temporal and Tactile Cueing (DTTC) (https://doi.org/10.1044/2019_ajslp-19-0005)
- View online videos and demonstrations instructing clinicians in the procedures relevant to Dynamic Therapy (duration: 2-4 hours)
- Read and implement the Dynamic Therapy treatment manual. A treatment manual has been designed for this study. Once all participants have completed their Dynamic Therapy treatment, the manual will be publicly available on the Dynamic Therapy website.
- Where possible, clinicians will be encouraged to treat a non-RCT child or children in their regular clinical practice with DTTC before treating research participants.
- Receive feedback on their treatment fidelity from the Fidelity Manager, Megan Leece.
- Receive a one-hour video coaching session from a Dynamic Therapy expert, AI Professor Edythe Strand.

An online community of practice will also be established. This community of practice will include a chat function for discussion between the clinicians moderated by one of the CIs or the Fidelity Manager, a questions portal for direct access to our group of Dynamic Therapy experts (CIs and AIs) and a resources portal where the clinicians will be able to re-visit training videos, the training manual, relevant research articles and ask questions.

MODE OF DELIVERY:

Participants will receive treatment in-person, face-to-face.

LOCATION:

In Australia and the United States, children will receive therapy at one of the identified clinical sites, or, if indicated by the participant's parent/carer, in community facilities (e.g. Libraries) or in the participant's home.

TREATMENT DOSAGE:

Children in this study will be randomised to one of two arms: the experimental treatment arm (Dynamic Therapy) (n=60) or the usual care arm (n=60).
Child participants in the experimental treatment arm will receive Dynamic therapy totalling 18 hours over five consecutive weeks (target = 4 sessions per week for 4 weeks, while allowing for five weeks to achieve the 18 total sessions). Prior to receiving the studied intervention, participants will engage in a probe data collection session (week 0/baseline). After they finish their final Dynamic Therapy session they will complete an immediate probe (completed on the same day) and one final probe session 4-weeks after their final treatment session. Electronic data will be collected about additional therapy the child may be receiving from their community-based speech pathologist on a weekly basis for the duration of their participation in this study (i.e., 9 weeks, commencing once they are in their first week of therapy).

TREATMENT FIDELITY:

To ensure all children are provided with the most effective treatment:
- All clinicians will undergo standardised training in how to provide Dynamic Therapy. Dr Edythe Strand will watch the treating clinician’s first, second or third Dynamic Therapy session with their first participant and will provide coaching feedback.
- A standardised treatment manual will be used.
- Treatment fidelity will be calculated on the first and second Dynamic Therapy treatment sessions and on a randomly selected third session. Fidelity calculations will be conducted synchronously and feedback will be provided to the treating clinician via email or a video conference call regarding any changes required. Treatment fidelity will be reported.
Intervention code [1] 319229 0
Behaviour
Comparator / control treatment
Usual Care Arm

Child participants in the Usual Care arm will continue their usual care which we will monitor for 9 consecutive weeks. For example, if the child was seeing a speech pathologist for one hour, once per week, prior to their involvement in this study, they can continue that care, although they are able to change or discontinue therapy as they wish. Electronic data will be collected on a weekly basis for participants in the Usual Care arm from either the treating speech pathologist or from their parent. Treatment data collected during this period will include treatment used, treatment goals, therapy progress and minutes of therapy per week the child attended. Other data collected from the community-based (i.e., usual care) treating speech pathologist will include their demographic data such as the speech pathologist’s highest level of qualification and their experience treating Childhood Apraxia of Speech. Children in this arm will complete probes at the beginning of the trial (pre-probe), at 5 weeks and at 9 weeks.

Usual Care Data Collection for all Participants

Although children will be randomised to one of the two arms (experimental treatment arm or Usual Care arm), the usual care questionnaire will be completed by community-based speech pathologists/family for all enrolled children to collect data for their entire enrolment period (starting from their first week).
Control group
Active

Outcomes
Primary outcome [1] 325919 0
Percentage of Phonemes Correct (PPC) will be calculated for treatment words and will be assessed for changes.

Instrument: Treatment words targeted in therapy will be recorded by the speech pathologist using a Single word assessment tool (Generalisation Probe created by the research team).
Timepoint [1] 325919 0
For both arms of the study: Baseline (Week 0), week 5 and week 9 post-intervention commencement.
Primary outcome [2] 326494 0
Percentage Phonemes Correct (PPC) across untreated words [generalisation].

Instrument: Single word assessment tool (Generalisation Probe created by the research team) plus the words in the Goldman Fristoe Test of Articulation.
Timepoint [2] 326494 0
For both arms of the study: Baseline (Week 0), week 5 and week 9 post-intervention commencement.
Secondary outcome [1] 389506 0
Untreated words in picture naming and direct imitation judged by a blinded assessor using a three-point scale; 2 = correct, 1 = one or two errors, 0 = more than two errors (Strand et al., 2013).

Instrument: Single word assessment tool (Generalisation Probe created by the research team).
Timepoint [1] 389506 0
For both arms of the study: Baseline (Week 0), week 5 and week 9 post-intervention commencement.
Secondary outcome [2] 389507 0
Performance on Speech Prosody Score, using the method as outlined in McCabe, Preston, Evans & Heard (submitted for publication). The single word assessment tool (Generalisation Probe created by the research team) will be used to calculate the Speech Prosody Score.
Timepoint [2] 389507 0
For both arms of the study: Baseline (Week 0), week 5 and week 9 post-intervention commencement.
Secondary outcome [3] 391686 0
Quality of life.

Instrument: The CHU-9D (Chen et al., 2014).
Timepoint [3] 391686 0
For both arms of the study: Baseline (Week 0), week 5 and week 9 post-intervention commencement.
Secondary outcome [4] 393868 0
Communicative participation.

Instrument: FOCUS-34 questionnaire (Thomas-Stonell et al., 2013).
Timepoint [4] 393868 0
For both arms of the study: Baseline (Week 0), week 5 and week 9 post-intervention commencement.
Secondary outcome [5] 393869 0
Speech Participation.

Instrument: The Speech Participation and Activity Assessment for Children (SPAA-C) (McLeod & McCormack, 2007).
Timepoint [5] 393869 0
For both arms of the study: Baseline (Week 0), week 5 and week 9 post-intervention commencement.
Secondary outcome [6] 407508 0
Cost effectiveness of speech pathology treatment. Instrument: Health Economics Survey (developed by the research team).
Timepoint [6] 407508 0
For both arms of the study: Baseline (Week 0), week 5 and week 9 post-intervention commencement.

Eligibility
Key inclusion criteria
1. Confirmed diagnosis of Apraxia using the criteria operationalised in the Diagnostic Evaluation of Motor Speech Skills (DEMSS).
2. Aged 3 years old- 7 years and 11 months at the time of the baseline probe.
3. Speech impairment in moderate-severe range as per the Goldman-Fristoe Test of Articulation-3 (Goldman & Fristoe, 2015).
4. Normal hearing and vision with or without corrective devices [glasses, hearing aids].
5. English as primary language of the child.
Minimum age
36 Months
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Concomitant genetic or neurodevelopmental disorder e.g. autism, global developmental delay, primary dysarthria diagnosis.
2. Oral or facial structural deficit e.g. cleft palate.

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)
The Clinic Site Lead will assign the child to one of the treating clinicians and request a random assignment from the Central Data Manager. The Central Data Manager will use a pre-randomised data sheet to allocate the participant to a group with blinding.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).

Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
NUMBER OF PARTICIPANTS

A total of 120 children (aged 3.0 years-7;11 years) with apraxia will be recruited. The pooled Improvement Rate Difference (the Single Case analogue to Risk Difference) obtained from the five experimental single case design studies reported in Table 1 is 0.65. According to guidelines reported by Parker, Vannest and Brown (2009), an IRD of 0.7 equates to a large effect size, with values 0.5 to 0.7 equating to moderate effect sizes. These values would convert an IRD of 0.65 to an approximate d = 0.75 or r = 0.45. With power set to 0.9 and alpha to 0.05, the primary comparison of percent phonemes correct after 18 sessions of DTTC (over 5 weeks) versus usual care would require an approximate sample size of 42 people per group, not allowing for the effects of nesting within treatment centres. The magnitude of nesting effects is unknown and data are not available to estimate it, so a conservative decision was made to increase sample sizes by 25% to account for loss of power through nesting, leading to a required sample size of 55 per group over 2 groups. Adding 10% for possible attrition we will recruit 120 children over three years. Based on our previous work, to achieve a total of 120 enrolled children across the 10 sites, we anticipate assessment of 150 potential participants (Murray, McCabe, & Ballard, 2015). Child verbal assent and carer written consent will be obtained.

STATISTICAL METHODS/ ANALYSIS PLAN

Initial analysis will use basic descriptive statistics: Means and standard deviations for the ratio-level primary outcome measures of percent phonemes correct and statistical control measures, such as age in months, and frequency counts for categorical demographic measures, such as country of residence and type of standard care. The planned analysis is a series of multi-level linear models for each of the primary outcome measures (percent phonemes correct for treated words and untreated words). The models will firstly test if the variables "clinician" and “site” are related to outcome and, if they are, treat them as a random variable, to enhance generalisability of findings to clinicians and sites not part of the study. Because the arms will be randomly allocated rather than matched, the models will also adjust for age of client and severity of condition, as potential confounders.
The overall effectiveness of the intervention will involve comparison of time points between the two primary arms (Aim 1):

1. Comparing baseline performance for both arms compared to immediate post (i.e., 5 weeks post baseline) to ascertain acquisition;
2. Comparing performance at immediate post (i.e., week 5) and subsequent follow up probes (i.e., week 9) to ascertain retention.
The Speech Prosody score and the Quality-of-Life measures will be analysed using multilevel linear models, as with the primary outcome measures.
Exploratory comparison of the two arms (A, B) will also be completed (Aim 2) using multilevel linear models as above.
3. Comparing baseline performance for both Arms A and B with immediate post (i.e., week 5).
4. Comparing baseline performance for both Arms A and B with performance at 4 weeks following completion of therapy (i.e., week 9).

Health Economics Evaluation (Aim 3)

A within-trial analysis will assess the cost-effectiveness of introducing Dynamic Therapy in two ways. First, a cost per improvement in child outcome measures (listed above) will be estimated. Cost collection will include the cost of Dynamic Therapy and the time taken for SP/ professionals to complete the assessments. Second, analyses will convert responses on the CHU-9D into utility values, using the CHU-9D algorithm for Australian and US populations. These utility values will be used in the calculation of a cost per quality-adjusted life year (QALY), also known as an incremental cost effectiveness ratio (ICER). Uncertainty will be investigated using univariate and multi-variate sensitivity analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/02/2022
Actual
1/06/2022
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
120
Accrual to date
54
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,WA,VIC
Recruitment postcode(s) [1] 32291 0
2006 - The University Of Sydney
Recruitment postcode(s) [2] 32292 0
2617 - University Of Canberra
Recruitment postcode(s) [3] 32293 0
6102 - Bentley
Recruitment postcode(s) [4] 32294 0
4811 - James Cook University
Recruitment postcode(s) [5] 33217 0
3053 - Carlton
Recruitment postcode(s) [6] 37075 0
7310 - Devonport
Recruitment outside Australia
Country [1] 23271 0
United States of America
State/province [1] 23271 0
Philadelphia
Country [2] 23446 0
United States of America
State/province [2] 23446 0
New York

Funding & Sponsors
Funding source category [1] 307366 0
Government body
Name [1] 307366 0
The National Health and Medical Research Council (NHMRC)
Country [1] 307366 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 308121 0
None
Name [1] 308121 0
Address [1] 308121 0
Country [1] 308121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307453 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 307453 0
Ethics committee country [1] 307453 0
Australia
Date submitted for ethics approval [1] 307453 0
05/02/2021
Approval date [1] 307453 0
07/04/2021
Ethics approval number [1] 307453 0
Project Number: 2021/117
Ethics committee name [2] 307455 0
The Sydney Children's Hospitals Network Human Research Ethics Committee (SCHN HREC)
Ethics committee address [2] 307455 0
Ethics committee country [2] 307455 0
Australia
Date submitted for ethics approval [2] 307455 0
21/05/2021
Approval date [2] 307455 0
Ethics approval number [2] 307455 0
Ethics committee name [3] 307526 0
The Office of Research Integrity and Protections, Syracuse University
Ethics committee address [3] 307526 0
Ethics committee country [3] 307526 0
United States of America
Date submitted for ethics approval [3] 307526 0
30/04/2021
Approval date [3] 307526 0
Ethics approval number [3] 307526 0

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

Contacts
Principal investigator
Name 107286 0
Prof Patricia McCabe
Address 107286 0
Susan Wakil Health Building D18
Western Avenue, The University of Sydney, Camperdown, NSW 2006
Country 107286 0
Australia
Phone 107286 0
+61 2 9351 9747
Fax 107286 0
Email 107286 0
tricia.mccabe@sydney.edu.au
Contact person for public queries
Name 107287 0
Maryane Gomez
Address 107287 0
Susan Wakil Health Building D18
Western Avenue, The University of Sydney, Camperdown, NSW 2006
Country 107287 0
Australia
Phone 107287 0
+61 2 9351 0996
Fax 107287 0
Email 107287 0
dttc.trial@sydney.edu.au
Contact person for scientific queries
Name 107288 0
Patricia McCabe
Address 107288 0
Susan Wakil Health Building D18
Western Avenue, The University of Sydney, Camperdown, NSW 2006
Country 107288 0
Australia
Phone 107288 0
+61 2 9351 9747
Fax 107288 0
Email 107288 0
tricia.mccabe@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
For the purposes of confidentiality and participant safety, individual participant data will not be made available for this trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9967Study protocol https://dynamic.sydney.edu.au/  The study protocol can be requested by emailing Pr... [More Details]
9968Statistical analysis plan https://dynamic.sydney.edu.au/  The statistical plan can be requested by emailing ... [More Details]
10076Clinical study report https://dynamic.sydney.edu.au/  The clinical study report can be requested by emai... [More Details]
10757Ethical approval https://dynamic.sydney.edu.au/  Ethical approval has been granted by The Universit... [More Details]
10759Analytic code https://dynamic.sydney.edu.au/  The analytic code can be requested by emailing Pro... [More Details]
10760Informed consent form https://dynamic.sydney.edu.au/  The consent form can be requested by emailing Dr M... [More Details]



Results publications and other study-related documents

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