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Trial registered on ANZCTR


Registration number
ACTRN12624000946516
Ethics application status
Approved
Date submitted
25/05/2024
Date registered
5/08/2024
Date last updated
5/10/2024
Date data sharing statement initially provided
5/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Dynamic Tactile Temporal Cueing in improving speech and communicative participation in children with cerebral palsy: An exploratory sequential mixed methods study
Scientific title
Effectiveness of Dynamic Tactile Temporal Cueing in improving speech and communicative participation in children with cerebral palsy aged 3 to 8 years: An exploratory sequential mixed methods study
Secondary ID [1] 311538 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 332891 0
Dysarthria speech disorder 332892 0
Condition category
Condition code
Neurological 329608 329608 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dynamic Tactile Temporal Cuing (DTTC) is a motor speech intervention designed for young children with severe motor speech disorders including childhood apraxia of speech (CAS), a similar condition to dysarthria in cerebral palsy. DTTC focuses on learning to move the muscles required for speaking while learning to say words.
DTTC involves stimulation techniques of “look at me, listen to me, say what I say”. A set of 20 meaningful target words that contain sounds that the child already can produce and those sounds that are emerging are practiced in intensive drill.
The speech pathologist systematically works toward independent (non-imitated) production of the words by fading cues in a cueing hierarchy. The cues include slow speaking rate, the length of time between clinician model and child’s response, and tactile cues to demonstrate articulatory configurations (the movements and placement of the tongue, cheeks, and lips). Rapid reinforcers (feedback on the correctness of the production and on how to produce the word/ phrase) are used to maximize the number of practice trials per session. Cues are individual to the child and the clinician moves along the cuing hierarchy to facilitate accurate production while moving towards independent production.

DTTC intervention will be provided three times a week for six weeks by speech pathologists trained in DTTC intervention. Each session runs for one hour. The sessions will be in-person at a Cerebral Palsy Alliance site closest to the participant's home.

All treating speech pathologists will undergo training for DTTC a minimum of one month before the commencement of the intervention. The following training will take place:
1. Complete DTTC online training https://childapraxiatreatment.org/dttc/.
2. Complete a three-hour training on the implementation of DTTC, delivered over two or three sessions depending on the speech pathologist’s availability. The CI or the other speech pathologists in the research team will provide the training individually to each speech pathologist or in groups of two online or in-person. A standardized DTTC intervention manual will be developed and used in the training.
3. The CI or the other speech pathologists in the team will observe the treating clinician’s first or the second treatment session with their first participant after which they will provide coaching feedback to the speech pathologist.

Adherence to DTTC intervention will be monitored by the Chief Investigator (CI) and the other speech pathologists in the research team. In addition to the initial clinician observation, the CI or the other speech pathologists will also observe three more randomly selected treatment sessions to observe fidelity to the DTTC intervention. If Fidelity drops below 90%, the speech pathologist will be provided with further training and support by the Chief Investigator or other speech pathologists in the research team.

The length of baselines:
Following the pre-treatment assessment, children will be randomized to complete 3, 4 or 5 pre-treatment probe assessments during baseline period. Children will be randomized to one of the following conditions:
- 3 pre-treatment probes: 2 x on 1 week before treatment and 1x on the first week of treatment
- 4 pre-treatment probes: 1 x on 2 weeks before treatment, 2 x 1 week before treatment, 1 x 1 on
the first week of treatment.
- 5 pre-treatment probes: 2 x on 2 weeks before treatment, 2 x 1 week before treatment, 1 x 1 on
the first week of treatment
Intervention code [1] 327996 0
Treatment: Other
Comparator / control treatment
The multiple baseline measures in this single-case experimental study will be used to establish stable pre-treatment probe measures. The same probe measures will continue to be taken weekly throughout the treatment and five more time after the treatment. To calculate treatment effect, the baseline probe measures will be compared to the probe measures during the treatment within each individual participant. There are no control groups in this study. Each participant is measured against their own behavior.
The probe measures will be a 50-item wordlist, individualized to each child which includes 20 to-be-treated (the intervention target words), 20 untreated-but-related (words similar to the target words but not treated) and 10 control words (individually chosen for each child that are not predicted to improved based on DTTC treatment.
Control group
Active

Outcomes
Primary outcome [1] 337405 0
Percentage of phonemes correct in the target words (PPC_TrW)
Assessment method [1] 337405 0
The assessment method of the primary outcome of percentage of phonemes correct will involve the calculation of the percentage of phonemes correct in 20 target words obtained with the Diagnostic Evaluation of Articulation and Phonology (Dood et al., 2002)
Timepoint [1] 337405 0
The primary outcome measure will be taken at: 1) At pre-commencement, minimum of 3 weeks before commencement of therapy. 2) At baseline 1 or 2 weeks before commencement of therapy (the participants will be randomised to 3,4 or 5 baseline measures). 3) Once a week for the duration of therapy. 4) 2 times at 1 week post intervention completion. 5) 2 times at 2 weeks post intervention. 6) 1 time at 4 weeks post intervention.
Secondary outcome [1] 431740 0
Percentage of phonemes correct in 20 untreated single words (PPC_UtrSW)
Assessment method [1] 431740 0
The assessment method of the primary outcome of percentage of phonemes correct will involve the calculation of the percentage of phonemes correct in 20 untreated words obtained with the Diagnostic Evaluation of Articulation and Phonology (Dood et al., 2002)
Timepoint [1] 431740 0
The secondary outcome measure will be taken at: 1) At pre-commencement, minimum of 3 weeks before commencement of therapy. 2) At baseline 1 or 2 weeks before commencement of therapy (the participants will be randomised to 3,4 or 5 baseline measures). 3) Once a week for the duration of therapy. 4) 2 times at 1 week post intervention completion. 5) 2 times at 2 weeks post intervention. 6) 1 time at 4 weeks post intervention.
Secondary outcome [2] 435502 0
Intelligibility in words (Int_W)
Assessment method [2] 435502 0
The Word Intelligibility by Picture Identification test (WIPI) will be used. Six phonetically similar words, represented as pictures on one page, are presented to the participant who names one of the words. The rater matches the word against the pictures on the page and rates it in intelligibility. The rating scale: 0 = not able to identify the word because of unintelligibility 1 = able to identify the word but speech is difficult to understand 2 = able to identify the word and speech is easy to understand A percentage of intelligibility is calculated from the rating scale score.
Timepoint [2] 435502 0
The secondary outcome measure will be taken: 1) At pre-commencement, minimum of 3 weeks before commencement of therapy. 2) 2 weeks after the completion of the intervention block.
Secondary outcome [3] 435503 0
Parent reported outcomes on communicative participation (FOCUS)
Assessment method [3] 435503 0
Focus On Communication Under Six assessment (FOCUS; (Thomas-Stonell et al., 2010) form will be emailed to the participating families to fill in. Once completed, the family will email the assessment form back to the CI.
Timepoint [3] 435503 0
The secondary outcome measure will be taken: 1) At pre-commencement, minimum of 3 weeks before commencement of therapy. 2) 2 weeks after the completion of the intervention block.
Secondary outcome [4] 435506 0
Parent reported outcomes on intelligibility and participation (ICS)
Assessment method [4] 435506 0
The Intelligibility on Context Scale (ICS) (McLeod et al., 2015) form will be emailed to the participating families to fill in. Once completed, the family will email the assessment form back to the CI.
Timepoint [4] 435506 0
The secondary outcome measure will be taken: 1) At pre-commencement, minimum of 3 weeks before commencement of therapy. 2) 2 weeks after the completion of the intervention block.
Secondary outcome [5] 435508 0
Parent reported outcome on performance (COPM_P)
Assessment method [5] 435508 0
The Canadian Occupation Performance measure – Performance (COPM_P) (ØstensjØ et al., 2008) orm will be emailed to the participating families to fill in. Once completed, the family will email the assessment form back to the CI.
Timepoint [5] 435508 0
The secondary outcome measure will be taken: 1) At pre-commencement, minimum of 3 weeks before commencement of therapy. 2) 2 weeks post-completion of the intervention block
Secondary outcome [6] 436500 0
Parent/ guardian acceptability of DTTC (TFAQ_Pa)
Assessment method [6] 436500 0
The parent/ guardian will access the Theoretical Framework of Acceptability Questionnaire (Sekhon et al., 2017 ) and fill in online from The University of Sydney REDCap.
Timepoint [6] 436500 0
The secondary outcome measure will be taken: 1) 2 weeks after the completion of the intervention block.
Secondary outcome [7] 436501 0
The treating speech pathologist acceptability of DTTC (TFAQ_SP)
Assessment method [7] 436501 0
The treating speech pathologist will access the Theoretical Framework of Acceptability Questionnaire (Sekhon et al., 2017 ) and fill in online from The University of Sydney REDCap.
Timepoint [7] 436501 0
The secondary outcome measure will be taken: 1) 1 week after the completion of the intervention block.
Secondary outcome [8] 436502 0
Parent’s/ Guardian’s reflections on experiences with DTTC. (Int_Pa)
Assessment method [8] 436502 0
The parent/ guardian will attend a semi-structured interview with one member of the research team (Sarah Reedman) to discuss their reflections and experiences with DTTC to capture barriers and facilitators to implementation (Breimaier et al., 2015)
Timepoint [8] 436502 0
The secondary outcome measure will be taken: 1) Within 4 weeks after the completion of the intervention block.
Secondary outcome [9] 436503 0
The treating speech pathologist's reflections on experiences with DTTC. (Int_SP)
Assessment method [9] 436503 0
The treating speech pathologists will attend a semi-structured interview with one member of the research team to discuss their reflections and experiences with DTTC to capture barriers and facilitators to implementation (Breimaier et al., 2015)
Timepoint [9] 436503 0
The secondary outcome measure will be taken: 1) Within 2 weeks after the completion of the intervention block.

Eligibility
Key inclusion criteria
1. Diagnosis of CP
2. Viking Speech Scale (VSS) II-IV
3. No diagnosed intellectual disability
4. Normal or adjusted-to-normal hearing and vision
5. English as primary language
Minimum age
3 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Concomitant genetic or neurodevelopmental disorder
2. Oral or facial structural deficit

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)
Allocation to the number of baseline measures 3,4 or 5 will take place in the following way:
A University of Sydney staff who is unrelated to the study will draw an unmarked envelope that will indicate the number of baseline probe assessments.
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
Other
Other design features
This is an n or 1 randomised controlled trial, an experimental study featuring a non-concurrent, randomised multiple-baseline across subjects design followed by a single intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Single case experimental design – sequential mixed methods across multiple baselines with participants

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315835 0
Charities/Societies/Foundations
Name [1] 315835 0
Cerebral Palsy Alliance Emerging Researcher Grant
Country [1] 315835 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Country
Australia
Secondary sponsor category [1] 317963 0
None
Name [1] 317963 0
Country [1] 317963 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314690 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 314690 0
Ethics committee country [1] 314690 0
Australia
Date submitted for ethics approval [1] 314690 0
25/03/2024
Approval date [1] 314690 0
29/07/2024
Ethics approval number [1] 314690 0
2024/HE000616

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 132406 0
Dr Marjut (Johanna) Korkalainen
Address 132406 0
Cerebral Palsy Alliance, 187 Allambie Road, Allambie Heights, NSW 2100
Country 132406 0
Australia
Phone 132406 0
+61 456236323
Email 132406 0
jkorkalainen@cerebralpalsy.org.au
Contact person for public queries
Name 132407 0
Johanna (Marjut) Korkalainen
Address 132407 0
Cerebral Palsy Alliance, 187 Allambie Road, Allambie Heights, NSW 2100
Country 132407 0
Australia
Phone 132407 0
+61 299758719
Email 132407 0
jkorkalainen@cerebralpalsy.org.au
Contact person for scientific queries
Name 132408 0
Marjut (Johanna) Korkalainen
Address 132408 0
Cerebral Paly Alliance, 187 Allambie Road, Allambie Heights, NSW 2100
Country 132408 0
Australia
Phone 132408 0
+61 456236323
Email 132408 0
jkorkalainen@cerebralpalsy.org.au

Data sharing statement
Will the study consider sharing individual participant data?
No


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.