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Trial registered on ANZCTR


Registration number
ACTRN12622001135707
Ethics application status
Approved
Date submitted
21/06/2022
Date registered
17/08/2022
Date last updated
16/11/2023
Date data sharing statement initially provided
17/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Speech therapy for children with Childhood Apraxia of Speech (CAS): DTTC provided via a blocked schedule (1 x 3hr/ week) or a distributed schedule (3 x 1hr/ week) across 8 weeks.
Scientific title
Dynamic Temporal and Tactile Cueing (DTTC) for children with Childhood Apraxia of Speech (CAS):. Parallel Single Case Experimental Design investigations of dose frequency: blocked (1 x 3-hr / week) and distributed (3 x 1-hr / week)
Secondary ID [1] 307402 0
Nil known
Universal Trial Number (UTN)
U1111-1279-6193
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Apraxia of Speech 326735 0
Condition category
Condition code
Physical Medicine / Rehabilitation 323969 323969 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Speech therapy using Dynamic Temporal and Tactile Cuing Treatment (DTTC, Strand 2020). Participants are taught 5 - 20 functional words or phrases (e.g. 'my turn', 'no way'). During the therapy session, the child is instructed to "look at me, copy me". The child copies the clinician's production, and as the child's skills improve, the clinician reduces the support provided (e.g. increasing the time between the clinician's and child's production, increasing the use of tactile cues such as touching the child's chin or cheeks).

Provided by: Speech Pathologists (Australia) or Speech-Langauge Pathologists (USA) who have at least 5 years of experience and have attended a half-day training regarding the intervention procedures.

Mode of delivery: face-to-face, individually

Number of times intervention is administered: Therapy will be provided individually by an experienced speech pathologist for 3 hours per week across 8 weeks. The participants families can select whether they would like to receive (a) one 3-hr session week or (b) three 1-hr sessions per week. Following the treatment, participants will attend follow-up sessions at one day , one week, one month, and three months.

Location of intervention: The intervention and follow-up sessions will be held in speech pathology clinics of research partners who are working in private practice. We anticipate working with private practitioners in NSW and in the USA.

Personalisation of the treatment: Each participant will have a unique set of 20 treatment items (words or phrases). DTTC treatment is always individualized and uses items that are functionally relevant for each child. This is so that the child is motivated to learn to say the therapy words and phrases. The individualisation of the treatment will occur between the eligibility assessment and the baseline sessions. It will be done by the research team using information about the child's current consonant inventory, word shapes, and motivating words and phrases.

Treatment fidelity will be assessed by research team members (Dr Elizabeth Murray and Jenya Iuzzini-Seigel). It will be performed on 6 hours of treatment, using an established checklist for DTTC fidelity. Three hours of therapy in the first week will be examined for fidelity and the remaining 3 hours per participant will be randomly selected. The treating clinician will be provided with feedback about the fidelity rating and coaching to improve any areas of concern. The feedback is provided prior to the child's next session
Intervention code [1] 323841 0
Treatment: Other
Comparator / control treatment
No control group. This study will collect data from two parallel single case experimental design (SCED) studies, each investigating one dose frequency, either blocked (1 x 3hr/ week) or distributed (3 x 1hr/ week) for 8 weeks. Each study will have a baseline phase with where the children's accuracy will be monitored across 3 -5 baseline sessions (number of baselines to be randomly allocated). The baseline sessions will be conducted twice per week, meaning that children's speech is monitored across a 2-3 week baseline period prior to the commencement of treatment. Each participant serves as their own control, with their baseline data being the 'control' treatment condition.

The data from each of these SCED will be analysed separately. There will be no direct comparison of the two dose frequencies. This is because each dose frequency has an n of 4 and the study is intended to establish initial evidence for the efficacy of the session schedule, combining a SCED design and thematic analysis from parents and clinicians regarding their experiences of the session scheduling
Control group
Active

Outcomes
Primary outcome [1] 331770 0
Whole word accuracy as measure on the 64-item speech assessment task as measured with the 0,1,2 scale (Strand et al., 2020)
Timepoint [1] 331770 0
Due to the SCED design, the primary timepoints are baseline (3-5 baseline points per participant, randomly allocated), treatment phase (immediately prior to the 7th, 13th and 19th hour of therapy) and follow-up (1 day, 1 week, 4 weeks and 3 months post-treatment)
Secondary outcome [1] 411065 0
Percentage of Consonants Correct on a 64-item speech production task. The task has 20 treatment words and 44 untreated items.
Timepoint [1] 411065 0
Due to the SCED design, the timepoints are baseline (3-5 baseline points per participant, randomly allocated), treatment phase (immediately prior to the 7th, 13th and 19th hour of therapy) and follow-up (1 day, 1 week, 4 weeks and 3 months post-treatment)
Secondary outcome [2] 411076 0
Functional communication changes reported by parents using the Functional Outcomes of Communication Under Six (FOCUS 34)
Timepoint [2] 411076 0
Initial assessment compared with one month post-treatment
Secondary outcome [3] 413014 0
Percentage of consonants correct (PCC) on treated items on the 64-item speech assessment task
Timepoint [3] 413014 0
Baseline (3-5 baseline points per participant, randomly allocated), treatment phase (immediately prior to the 7th, 13th and 19th hour of therapy) and follow-up (1 day, 1 week, 4 weeks and 3 months post-treatment)
Secondary outcome [4] 413015 0
Thematic analysis of semi-structured interviews with carers . The interviews will be one hour in length and explore the participants' experiences of (a) participating in the research study, (b) the dose frequency [either 1 x 3 hr/ week, or 3 x 1hr/ week]0, and (c) the treatment used [DTTC, Strand 202]). The data will be analysed using reflexive thematic analysis (Braun & Clakre, 2021)
Timepoint [4] 413015 0
Collected between 1- and 4-weeks post-treatment
Secondary outcome [5] 413016 0
Goldman Fristoe Test of Articulation - third edition (GFTA-3) standard score
Timepoint [5] 413016 0
one month post treatment
Secondary outcome [6] 413017 0
Inconsistency Severity Percentage (Iuzzini-Seigel, 2017)
Timepoint [6] 413017 0
One month post-treatment
Secondary outcome [7] 413019 0
Intelligibility as reported by parent on the Intelligiblity in Context Scale (McLeod et al., 2012)
Timepoint [7] 413019 0
One month post treatment
Secondary outcome [8] 413020 0
Thematic analysis of semi-structured interviews with clinicians. The interviews will be one hour in length and explore the participants' experiences of (a) participating in the research study, (b) the dose frequency [either 1 x 3 hr/ week, or 3 x 1hr/ week]0, and (c) the treatment used [DTTC, Strand 202]). The data will be analysed using reflexive thematic analysis (Braun & Clakre, 2021)
Timepoint [8] 413020 0
Collected between one week and one month post treatment (at participants' convenience)

Eligibility
Key inclusion criteria
The inclusion criteria are:
Children will:
a) have a primary diagnosis of CAS meeting all methods of identifying CAS
b) be aged 3-7 years (the core age group of the original DTTC design and efficacy studies)
c) have a Receptive Language Index standard score of 70 or greater (within 2 standard deviations of the mean) on the Clinical Evaluation of Language Fundamentals – Preschool 2nd edition or Clinical Evaluation of Language Fundamentals – 5th edition (Semel, Wiig, & Secord, 2004; Wiig, Secord, & Semel, 2006; Wiig, Semel, & Secord, 2013, 2017)
d) have a standard score of 70 or greater (within 2 standard deviations of the mean) on the nonverbal index of the Reynolds Intellectual Assessment Scales – 2nd edition (RIAS-2, Reynolds & Kamphaus, 2015) to ensure appropriate non-verbal intelligence
e) have at least 20 words they use regularly (allowing for speech inaccuracy and inconsistency) and with communicative intent, as measured using the US or AUS -normed version of the MacArthur Bates (CDI) parent questionnaire (Fenson et al., 2007).
Minimum age
3 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Abnormalities of oral structures (e.g. cleft palate)
Does not speaks English, and have at least one parent who speaks English
Has uncorrected hearing or vision problem
Has other developmental problems (e.g., autism spectrum disorder, global developmental delay)

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


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Parallel SCEDs (Multiple baselines across participants). Participants will select which of two dose frequency groups they would like to enrol in, either (a) one 3-hr/ week session, or (b) three 1-hr/ week sessions. Four participants will be allocated to each condition. Once four participants have been recruited to each dose frequency, no further participants will be recruited for that dose frequency.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary method of analysis is visual analysis. DAta will be analysed to determine whether performance in the baseline phase is stable, and the introduction of treatment resulted in an improvement in the child's (a) treated items, (b) untreated items, and (c) whether any treatment or generalisation gains were retained in the follow-up period. These effects will be confirmed with Helmert Planned Orthogonal Contrasts comparing performance across phases (i.e treatment effect analysed by baseline phase performance vs treatment and follow-up phase performance; maintenancy analysed by treatment phase performance vs follow-up phase performance).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
8
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 41692 0
2213 - Panania
Recruitment postcode(s) [2] 41693 0
2250 - Erina
Recruitment outside Australia
Country [1] 24847 0
United States of America
State/province [1] 24847 0
Vermont

Funding & Sponsors
Funding source category [1] 311678 0
Charities/Societies/Foundations
Name [1] 311678 0
The Once Upon a Time Foundation
Country [1] 311678 0
United States of America
Primary sponsor type
University
Name
Marquette University
Address
Marquette University
1250 W. Wisconsin Avenue
Milwaukee, WI 53233
Country
United States of America
Secondary sponsor category [1] 313135 0
None
Name [1] 313135 0
Address [1] 313135 0
Country [1] 313135 0
Other collaborator category [1] 282333 0
University
Name [1] 282333 0
The University of Sydney
Address [1] 282333 0
Western Avenue
Camperdown
NSW 2006
Country [1] 282333 0
Australia
Other collaborator category [2] 282874 0
University
Name [2] 282874 0
University of Vermont
Address [2] 282874 0
The Eleanor M. Luse Center for Communication: Speech, Language and Hearing Pomeroy Hall, 489 Main St. Burlington, VT 05405
Country [2] 282874 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311133 0
The University of Sydney
Ethics committee address [1] 311133 0
Ethics committee country [1] 311133 0
Australia
Date submitted for ethics approval [1] 311133 0
28/02/2022
Approval date [1] 311133 0
08/04/2022
Ethics approval number [1] 311133 0
2022/155
Ethics committee name [2] 311135 0
Marquette University
Ethics committee address [2] 311135 0
Ethics committee country [2] 311135 0
United States of America
Date submitted for ethics approval [2] 311135 0
01/08/2021
Approval date [2] 311135 0
01/09/2021
Ethics approval number [2] 311135 0
3946

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

Contacts
Principal investigator
Name 120058 0
Dr Jenya Iuzzini-Seigel
Address 120058 0
Marquette University
Harriet Barker Cramer Hall,
604 N. 16th St
Room 230G
Milwaukee, WI 53201-1881
Country 120058 0
United States of America
Phone 120058 0
+14142881528
Fax 120058 0
Email 120058 0
jenya.iuzzini-seigel@marquette.edu
Contact person for public queries
Name 120059 0
Jenya Iuzzini-Seigel
Address 120059 0
Marquette University
Harriet Barker Cramer Hall, Room 230G
604 N. 16th St
Milwaukee, WI 53201-1881
Country 120059 0
United States of America
Phone 120059 0
+14142881528
Fax 120059 0
Email 120059 0
jenya.iuzzini-seigel@marquette.edu
Contact person for scientific queries
Name 120060 0
Jenya Iuzzini-Seigel
Address 120060 0
Marquette University
Harriet Barker Cramer Hall, Room 230G
604 N. 16th St
Milwaukee, WI 53201-1881
Country 120060 0
United States of America
Phone 120060 0
+14142881528
Fax 120060 0
Email 120060 0
jenya.iuzzini-seigel@marquette.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Our participants are children. Their carers will be invited to make their de-identified data available, but they have the option to decline this request.


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
No additional documents have been identified.