Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000571774
Ethics application status
Approved
Date submitted
31/03/2022
Date registered
14/04/2022
Date last updated
14/04/2022
Date data sharing statement initially provided
14/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Helping Children Say Long Words: the effect of a minimal pair approach on the ability of children with speech sound disorders to say long words accurately
Scientific title
Helping Children Say Long Words: a trial of minimal pairs for weak syllable deletion
Secondary ID [1] 306719 0
Nil known
Universal Trial Number (UTN)
U1111-1276-2628
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Speech Sound Disorder 325769 0
Phonological Impairment 325770 0
Condition category
Condition code
Physical Medicine / Rehabilitation 323106 323106 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children with speech sound disorders often have phonological processes, or patterns of sound errors, in their speech. One common pattern is deleting the weak or unstressed syllables in words. The aim of this study is to investigate a potential intervention for weak syllable deletion.

This study will investigate the use of minimal pair therapy, a well-established speech pathology intervention for treating phonological processes. This will involve asking children to practice saying pairs of words that only differ by the presence or absence of a weak syllable, e.g. ‘nana’ and ‘banana’. The study will consist of initial eligibility assessment, a 3-6 week baseline phase with data collection once per week, a six week intervention phase (2x 45 minute sessions per week), a post-intervention assessment and a follow up assessment one month later.

Intervention sessions will occur twice per week for 45 minutes either in a school or home setting. If this study is impacted by social distancing guidelines, these sessions may take place via telehealth. Intervention session one will consist of familiarising the participant with the first five target minimal pairs and auditory discrimination tasks using target minimal pairs, where the child is asked to listen and find the picture the speech pathologist names. Intervention sessions two to six will consist of 30 trials of auditory discrimination followed by 60-80 trials of production activities, both using target minimal pairs. One trial consists of the child identifying or naming both pictures in the minimal pair.

If the child does not produce the target word accurately, they will be given feedback that reinforces the idea that miscommunication has occurred and asked to revise their answer. If the child is unable to say the target words, facilitative cues and support will be offered.

Intervention Session 7 will introduce the second five minimal pairs, using the same familiarisation methodology, and intervention sessions eight to twelve will involve practice of all ten target minimal pairs. This procedure is based on the well-known and widely used minimal pairs approach.

At least two sessions per participant will be reviewed by a different member of the research team to assess the intervention for fidelity.
Intervention code [1] 323210 0
Treatment: Other
Intervention code [2] 323226 0
Behaviour
Comparator / control treatment
Prior to intervention, children's speech will be monitored weekly for 3-6 weeks during a baseline phase. In this phase, no intervention will be provided. Each participant serves as their own control, with their baseline data being the no treatment condition.
Control group
Active

Outcomes
Primary outcome [1] 330887 0
Percentage occurrence of word initial weak syllable deletion in trained words. This will be measured by asking children to name the 10 pictures of target words with word initial weak syllables practiced during therapy sessions.
Timepoint [1] 330887 0
This will be measured at weekly timepoints during both baseline (3-6 weeks) and intervention (6 weeks) phases.
Secondary outcome [1] 407926 0
Percentage occurrence of word initial weak syllable deletion in untrained words. This will be measured by asking children to name 10 pictures of words with word initial weak syllables that the child has not practiced during therapy sessions.
Timepoint [1] 407926 0
This will be measured at weekly timepoints during both baseline (3-6 weeks) and intervention (6 weeks) phases.
Secondary outcome [2] 407927 0
Percentage occurrence of word internal weak syllable deletion in untrained words. This will be measured by asking children to name 10 pictures of words with word internal weak syllables that the child has not practiced during therapy sessions.
Timepoint [2] 407927 0
This will be measured at weekly timepoints during both baseline (3-6 weeks) and intervention (6 weeks) phases.
Secondary outcome [3] 407928 0
Percentage occurrence of weak syllable deletion during a conversation-level task. This will be measured by asking the child to retell a story that has many multisyllabic words in it and calculating how many occurrences of weak syllable deletion were observed compared to the total number of multisyllabic words the child attempted.
Timepoint [3] 407928 0
This will be measured during initial assessment (pre-baseline phase), immediately post-intervention and at one month follow up assessment.

Eligibility
Key inclusion criteria
Eligibility will be determined using routine speech pathology assessment tools that involve either listening to an adult say words and pointing to the picture or looking at pictures and naming them. Children will be between 4 years and 5 year 11 months and have English as their first language.

Additionally, children will need to have receptive vocabulary within 1.5 SD of the mean as measured by the Peabody Picture Vocabulary Test, 5th edition (PPVT-5; Dunn, 2019). In the PPVT-5, the adult says a word and asks the child to look at a large book and choose the corresponding picture from four options.

Participants must have a the most common type of speech sound disorder—phonological impairment (identified by the Diagnostic Evaluation of Articulation and Phonology; DEAP, Dodd et al., 2002). In the DEAP, the adult shows the child pictures and asks the child to name them. If the child doesn’t know the answer, they will first be given two options (e.g. “Is it a cat or a dog?”) and if still incorrect asked to copy the adult. Participants must also meet the following speech criteria:
• At least four occurrences of word initial weak syllable deletion as measured on the Preschool Polysyllable Test (POP; Baker, 2013), a test that involves asking the child to name pictures of objects or actions with long (polysyllabic) names, e.g. ‘medicine’ or ‘avocado’.
• Able to say words with a strong-weak-strong stress pattern
• A phonemic inventory that includes nasals, plosives, fricatives and glides
• No established pattern of initial consonant deletion, glottal or /h/ replacement
Minimum age
4 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children will be excluded from participation if they:
• produce five or more words inconsistently on the DEAP screener, as this is indicative of a different type of speech sound disorder warranting a different type of therapy approach.
• present with clinical features or diagnosis of Childhood Apraxia of Speech or dysarthria, hearing loss, cleft lip and/or palate, global developmental delay or autism spectrum disorder.
• have already had speech intervention directly targeting multisyllabic words or weak syllable deletion.

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


The people assessing the outcomes
Intervention assignment
Other
Other design features
This is a single case experimental design using a multiple baseline across participants methodology. All participants will start with a baseline phase followed by an intervention phase (note that participants will be randomly allocated to different baseline lengths).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed through a combination of visual analysis and Tau-U statistical analysis. Visual analysis will involve both within-condition and between-condition analysis. Individual conditions or phases (e.g., baseline or intervention phase) will be analysed for level (mean outcome measure within a phase), trend (the slope of the best-fitting line) and variability (range and standard deviation). In addition, data patterns across phases will be compared, looking at the immediacy of the effect (some outcome measures, especially untrained words, are predicted to show a delayed effect), overlap of data between phases, and the consistency of data with similar phases (e.g. comparing intervention phase data across participants) (Kratchowill et al., 2013)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2022
Actual
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
31/10/2022
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 311046 0
University
Name [1] 311046 0
The University of Sydney
Country [1] 311046 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Sydney School of Health Sciences
Faculty of Medicine and Health,
Susan Wakil Health Building,
D18 Western Avenue
The University of Sydney
Camperdown NSW, 2006
Australia
Country
Australia
Secondary sponsor category [1] 312449 0
None
Name [1] 312449 0
Address [1] 312449 0
Country [1] 312449 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310594 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 310594 0
Ethics committee country [1] 310594 0
Australia
Date submitted for ethics approval [1] 310594 0
22/11/2021
Approval date [1] 310594 0
18/02/2022
Ethics approval number [1] 310594 0
2021/941

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

Contacts
Principal investigator
Name 118202 0
Prof Kirrie Ballard
Address 118202 0
Sydney School of Health Sciences
The University of Sydney
Susan Wakil Health Building
D18 Western Avenue
The University of Sydney
Camperdown NSW 2006
Australia
Country 118202 0
Australia
Phone 118202 0
+61 431416936
Fax 118202 0
Email 118202 0
[email protected]
Contact person for public queries
Name 118203 0
Claire King Bamford
Address 118203 0
Sydney School of Health Sciences
The University of Sydney
Susan Wakil Health Building
D18 Western Avenue
The University of Sydney
Camperdown NSW 2006
Australia
Country 118203 0
Australia
Phone 118203 0
+61 431416936
Fax 118203 0
Email 118203 0
[email protected]
Contact person for scientific queries
Name 118204 0
Claire King Bamford
Address 118204 0
Sydney School of Health Sciences
The University of Sydney
Susan Wakil Health Building
D18 Western Avenue
The University of Sydney
Camperdown NSW 2006
Australia
Country 118204 0
Australia
Phone 118204 0
+61 431416936
Fax 118204 0
Email 118204 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.