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Trial registered on ANZCTR


Registration number
ACTRN12616000849493
Ethics application status
Approved
Date submitted
24/06/2016
Date registered
29/06/2016
Date last updated
18/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a parent-delivered intervention for speech problems in children
Scientific title
Speech P.E.A.S: The Role of Parents in Intervention for Speech Problems in Children
Secondary ID [1] 289536 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Speech Sound Disorder 299244 0
Phonological Impairment 299246 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299257 299257 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to determine if intervention for speech problems in preschool-aged children is effective when delivered by parents and a speech pathologist. Specifically, this study will determine if “multiple oppositions” intervention, an approach established as effective when delivered intensively by a speech pathologist, is still effective when modified and delivered by parents in conjunction with a speech pathologist, with children who have a speech sound disorder.

The multiple oppositions approach is an evidence-based treatment for childhood speech sound disorders. It was developed from linguistic and behavioural principles, and is known to be effective when treating children with moderate to severe speech sound disorders.

Children and one of their parents will attend 1 one-to-one session lasting 60 minutes per week for 9 weeks. At this session, one of the researchers (who is also a speech pathologist) will deliver the multiple oppositions approach to the child and will train parents in how to deliver the multiple oppositions approach to their child. Parents will then provide the treatment at home (“home practice”) for up to 30 minutes twice per week.

The outline of the study is as follows:
*Eligibility assessment to determine if the child/parent meet the inclusion criteria for the study
*3 – 6 weeks of baseline data collection (children will be randomised to receive either 3, 4 , 5 or 6 baseline probes, in which a speech sample is collected from a child once per week monitor their speech)
*9 weeks of treatment in the clinic where the intervention is delivered by the researcher/speech pathologist and parents are trained. Sessions lasting 1 hour will be delivered once per week. During the 9 weeks, parents will be asked to do home practice for up to 30 minutes on two days.
*Immediate follow-up assessment lasting 60 minutes to monitor changes to the child’s speech
*Final follow-up assessment of child’s speech, four weeks after the immediate follow-up. At this session, parents will be interviewed about their experience of delivering the intervention at home. In total, this session will last 90 minutes.

Adherence will be monitored through parent self-report of home practice.
Intervention code [1] 295128 0
Treatment: Other
Intervention code [2] 295129 0
Behaviour
Comparator / control treatment
Children's speech will be monitored during a baseline period of 3-6 weeks prior to the commencement of intervention. This will serve as the control for each participant. No treatment will be administered during this period.
Control group
Active

Outcomes
Primary outcome [1] 298736 0
Pre-treatment and post-treatment comparison of performance on: the Diagnostic Evaluation of Articulation and Phonology (Dodd, Hua, Crosbie, Holm & Ozanne, 2002); the Phonological Assessment of Collapses of Contrast (Baker, 2013); the Polysyllable Preschool Test (Baker, 2013); through a connected speech sample, and; on probes of treated and untreated words (e.g. the baseline probe). These are all measures of speech accuracy, and form a composite outcome.
Timepoint [1] 298736 0
These will be collected at the initial (pre-treatment) assessment, immediate follow-up assessment (immediately following the final treatment session) and final follow-up assessment (four weeks after the final treatment session).

Probe data will be collected once per week during the baseline phase (e.g. 3 to 6 times depending on which baseline group the child is randomised to), and weekly during the treatment phase. It will also be conducted at the immediate follow-up assessment (immediately following the final treatment session) and final follow-up assessment (four weeks after the final treatment session).
Secondary outcome [1] 325105 0
Parents’ ability to implement the multiple oppositions approach, as measured by analysis of treatment fidelity.

This will include: assessment of number of home treatment sessions completed according to a home treatment diary, and; inclusion of key aspects of the intervention, as measured through parent self-report and an audio recording of four randomly allocated home-based sessions.
Timepoint [1] 325105 0
Parents will be asked to record how often they completed home treatment each week.

Inclusion of key aspects of intervention will be measured at four (4) randomly allocated time points during the 9 week treatment phase of the study. Parents will be asked to complete a self-checklist of their inclusion of key aspects of the intervention, and will audio record these home treatment activities for analysis by the research team.

Eligibility
Key inclusion criteria
Children recruited to this study will meet the following inclusion criteria:
Aged 3 years 0 months to 5 years 11 months
Willing to participate
Diagnosis of a speech sound disorder that is appropriate to treat using the multiple oppositions intervention approach (i.e. at least 6 sounds consistently in error across 2 or 3 manner categories of consonant production)
Normal receptive language, normal hearing and oral structure and function, and no other concomitant developmental diagnoses (e.g., autism)
English as strongest or equal-strongest language

Primary caregivers will meet the following inclusion criteria:
Willingness to attend weekly intervention sessions at The University’s speech pathology in Lidcombe and complete home practice activities between sessions, given training
Functional level of English
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
This is a multiple baseline across participants single-subject design. Participants will be randomly allocated to a baseline condition (i.e. 3, 4, 5 or 6 baseline probes). All participants will receive the same intervention.

Sealed opaque envelopes will be used to conceal allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There are four baseline conditions. We will collect 3, 4, 5 or 6 baseline probes from participating children. Each child will be randomly assigned to a baseline length using concealed allocation. That is, cards with baseline duration (i.e. 3, 4, 5 or 6) will be placed in opaque envelopes.

An independent person will randomly draw an envelope for each participant upon their enrolment in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
This is a multiple baseline across participants single-subject design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data from the intervention study (such as changes to production of speech sounds) will be plotted and analysed using visual analysis (Kazdin, 2011). Additionally, pre-, post- and follow-up assessment results will be compared for each participant using ANOVAs and other statistical methods as appropriate. Effect sizes for intervention will be calculated according to procedures outlined in Gierut et al. (2015).

Qualitative data from the post-intervention interviews will be analysed using thematic analysis. This is a qualitative analysis method commonly used for identifying and reporting patterns within interview data (Braun & Clarke, 2006).

Sample size calculations were not performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2016
Actual
23/09/2016
Date of last participant enrolment
Anticipated
Actual
22/02/2017
Date of last data collection
Anticipated
Actual
5/07/2017
Sample size
Target
12
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293911 0
University
Name [1] 293911 0
The University of Sydney
Country [1] 293911 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Health Sciences, University of Sydney
75 East Street, Lidcombe
NSW 2141
Country
Australia
Secondary sponsor category [1] 292737 0
None
Name [1] 292737 0
Address [1] 292737 0
Country [1] 292737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295332 0
HREC The University of Sydney
Ethics committee address [1] 295332 0
Ethics committee country [1] 295332 0
Australia
Date submitted for ethics approval [1] 295332 0
23/04/2016
Approval date [1] 295332 0
12/08/2016
Ethics approval number [1] 295332 0

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

Contacts
Principal investigator
Name 66906 0
Dr Elise Baker
Address 66906 0
Speech Pathology
Building C43S
Cumberland Campus
The University of Sydney
Lidcombe, NSW, 2141
Country 66906 0
Australia
Phone 66906 0
+61 2 9351 9121
Fax 66906 0
Email 66906 0
elise.baker@sydney.edu.au
Contact person for public queries
Name 66907 0
Ellie Sugden
Address 66907 0
Speech Pathology
Building C43S
Cumberland Campus
The University of Sydney
Lidcombe, NSW, 2141
Country 66907 0
Australia
Phone 66907 0
+61 2 9351 9642
Fax 66907 0
Email 66907 0
ellie.sugden@sydney.edu.au
Contact person for scientific queries
Name 66908 0
Elise Baker
Address 66908 0
Speech Pathology
Building C43S
Cumberland Campus
The University of Sydney
Lidcombe, NSW, 2141
Country 66908 0
Australia
Phone 66908 0
+61 2 9351 9121
Fax 66908 0
Email 66908 0
elise.baker@sydney.edu.au

No information has been provided regarding IPD availability


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.