Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000573651
Ethics application status
Approved
Date submitted
9/05/2014
Date registered
29/05/2014
Date last updated
29/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive flexibility and rule abstraction therapy in three year old children with atypical phonology: using practice to test theory.
Scientific title
For three year old children with atypical phonology is rule abstraction and cognitive flexibility therapy effective in improving cognitive flexibility, rule abstraction, phonology and phonological awareness.
Secondary ID [1] 284572 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Speech Disorder 291852 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292210 292210 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will attend 2 baseline sessions then 16 therapy sessions and a further 2 sessions to collect post-therapy data. Each therapy session will consist of games which focus on rule abstraction and cognitive flexibility.
a) Therapy sessions will be held twice weekly with each session lasting approximately 45 minutes. Therapy will last for 8 weeks.
b) Sessions will be individualised with the child and parent. Sessions will be administered by a Speech Pathology Honours student. c) Games will consist of puzzles, book sharing, play with toys such as farm animals which are familiar and appropriate for three year old children.
Each baseline session will last for approximately 45 minutes, and be held within the same week. During the post-therapy session data will be collected on cognitive flexibility, rule abstraction, phonology and phonological awareness.
Intervention code [1] 289346 0
Treatment: Other
Comparator / control treatment
The research design is repeated measures single-case study research design thus each participant will act as their own control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292082 0
Pre-and post-therapy outcomes will be measured using the Diagnostic Evaluation of Articulation and Phonology (DEAP) (Dodd, Hua, Crosbie, Holm, Ozanne 2006) to measure percent consonants correct, percent vowels correct and number of atypical errors.
Timepoint [1] 292082 0
1 week after the final therapy session.
Primary outcome [2] 292110 0
The Flexible Item Selection Task (FIST) (Jacques and Zelazo 2001) will be used to measure improvement in cognitive flexibility and rule abstraction during therapy.
Timepoint [2] 292110 0
1 week following completion of therapy block.
Primary outcome [3] 292137 0
The Cracking the Code phonological awareness measure (Kelly and Cicerello 2014) will be used to measure emergence of phonological awareness.
Timepoint [3] 292137 0
1 week after the final therapy session
Secondary outcome [1] 308179 0
A 40 word picture naming task will be used to measure speech sound errors, and number of atypical errors.
Timepoint [1] 308179 0
Baseline, one week after the final therapy session, and at the beginning of each therapy session.

Eligibility
Key inclusion criteria
Six participants from a larger longitudinal study will be invited to participate in the intervention study. All participants must be aged between 3;0 and 3;11 at the commencement of intervention, and have made more than 10 atypical errors on the Toddler Phonology Test when assessed at the age of 2.
Minimum age
36 Months
Maximum age
47 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will have hearing within normal limits, and have not attended formal speech and language therapy since being assessed.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289205 0
Self funded/Unfunded
Name [1] 289205 0
Country [1] 289205 0
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 287881 0
None
Name [1] 287881 0
Address [1] 287881 0
Country [1] 287881 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290979 0
Curtin Unviersity HREC
Ethics committee address [1] 290979 0
Ethics committee country [1] 290979 0
Australia
Date submitted for ethics approval [1] 290979 0
Approval date [1] 290979 0
03/04/2014
Ethics approval number [1] 290979 0
HR85/2013

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

Contacts
Principal investigator
Name 48238 0
Dr Mary Claessen
Address 48238 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth WA 6845
Country 48238 0
Australia
Phone 48238 0
61 8 92663472
Fax 48238 0
Email 48238 0
[email protected]
Contact person for public queries
Name 48239 0
Mary Claessen
Address 48239 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth WA 6845
Country 48239 0
Australia
Phone 48239 0
61 8 92663472
Fax 48239 0
Email 48239 0
[email protected]
Contact person for scientific queries
Name 48240 0
Mary Claessen
Address 48240 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth WA 6845
Country 48240 0
Australia
Phone 48240 0
61 8 92663472
Fax 48240 0
Email 48240 0
[email protected]

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.