Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000969662
Ethics application status
Approved
Date submitted
5/06/2014
Date registered
10/09/2014
Date last updated
10/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phonological Treatment of Arabic-Speaking Children in Kuwait (Kuwaiti/ Gulf Area dialect)
Scientific title
In Arabic speaking children will phonological intervention improve speech intelligibility on treated sounds in comparison to untreated sounds?
Secondary ID [1] 284739 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Speech disorders/ Phonological disorders 292102 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292438 292438 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This single case experimental design study will provide phonological therapy which has been shown to be effective in English in Arabic. The therapy is a traditional face–to-face session with speech pathologist. Each child will have individually selected treatment targets addressed in a behavioural intervention as per standard speech pathology clinical practice. Treatment will be provided three times per week for 10 weeks for one hour per session- a maximum total of 30 hours of therapy.
Intervention code [1] 289524 0
Treatment: Other
Comparator / control treatment
The research is using a multiple baselines within participants design so
some sounds will be treated and others will be held in reserve
(untreated) but measured to show that they do not change. If the
treated sounds change and the untreated ones do not then we will have
demonstrated both experimental control and treatment efficacy.
Control group
Active

Outcomes
Primary outcome [1] 292293 0
Primary outcome measure: Percentage Consonant Correct Pre-Treatment and Post-Treatment. Assessment tool is standardized language assessment which will provide us with the child's speech repertoire.
Test name: A 58-word picture naming Arabic articulation test will be used to evoke responses representing the initial, medial, and final consonants of Arabic (Amayreh, 2000).
Timepoint [1] 292293 0
The child's speech will be assessed prior and post treatment to assess change. Since the study is a multiple baseline design, some children will have more baselines than others, and therefore, the post treatment assessment will be at least after 12 weeks and maximum after 14 weeks.
Secondary outcome [1] 308662 0
Nil
Timepoint [1] 308662 0
Nil

Eligibility
Key inclusion criteria
The inclusion criteria will include monolingual Arabic-Kuwaiti speaking children who have identified/ or suspected to have a phonological/speech impairment without having any known concomitant difficulties such as hearing loss, cleft-lip/ or palate, stuttering, or neurological impairment.
Minimum age
3 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non Arabic speaker children.
Bilingual children
Other medical conditions that effect speech such as :hearing loss, cleft-lip/ or palate, stuttering, or neurological impairment.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a multiple baselines within participant design study. Each participant will start at different time while the others will continue to come to clinic to collect baseline from them. In this case we will have different baselines from each client to help us assess change due treatment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is difficult to determine what sample size is needed from previous research as studies on phonological contrast therapy available in the published research literature all have recruitment samples ranging between 1-6 participants. Only three cross-linguistic studies have used phonological contrast therapy with the following languages and number of participants; Cantonese with one participant only, Turkish with two participants only, and Portuguese with 14 participants. The research team has agreed on this particular size as the sample size depending on the availability of clients in Kuwait, and the ability to manage and control the study in the time frame given. Moreover, this sample size is adequate to provide statistical information regarding the effect size by using d statistic from Cohen (1988) as calculated by Busk and Serlin, 1992.

According to Beeson & Robey, 2006, any new treatment study is best to be examined in small number of clients to observe treatment effect. Therefore, this is a phase one study that we hope will answer if phonological contrast therapy applied in Arabic is effective or not.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2014
Actual
25/03/2014
Date of last participant enrolment
Anticipated
31/03/2014
Actual
31/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment outside Australia
Country [1] 6095 0
Kuwait
State/province [1] 6095 0
Kuwait

Funding & Sponsors
Funding source category [1] 289354 0
University
Name [1] 289354 0
Kuwait University
Country [1] 289354 0
Kuwait
Primary sponsor type
University
Name
Kuwait University
Address
Kuwait University
Cultural Relations Office
P.O Box 5969, Safat 13060, Kuwait
Country
Kuwait
Secondary sponsor category [1] 288039 0
None
Name [1] 288039 0
Address [1] 288039 0
Country [1] 288039 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291123 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 291123 0
Ethics committee country [1] 291123 0
Australia
Date submitted for ethics approval [1] 291123 0
Approval date [1] 291123 0
08/01/2014
Ethics approval number [1] 291123 0
2013/921

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

Contacts
Principal investigator
Name 48966 0
Mrs Manal Alsaad
Address 48966 0
75 East St, Lidcombe NSW 2141, Australia
The University of sydney, Rm S153, Cumberland Campus, The University of Sydney, Lidcombe NSW , 1825
Country 48966 0
Australia
Phone 48966 0
+61450048055
Fax 48966 0
Email 48966 0
[email protected]
Contact person for public queries
Name 48967 0
Patricia McCabe
Address 48967 0
Rm S153, Cumberland Campus , The University of Sydney Lidcombe NSW . 1825

Faculty of Health Sciences
Cumberland Campus C42
75 East Street
Country 48967 0
Australia
Phone 48967 0
+61 2 9351 9747
Fax 48967 0
+61 2 9351 9173
Email 48967 0
[email protected]
Contact person for scientific queries
Name 48968 0
Patricia McCabe
Address 48968 0
Rm S153, Cumberland Campus, The University of Sydney Lidcombe NSW 1825

Faculty of Health Sciences
Cumberland Campus C42
75 East Street
Country 48968 0
Australia
Phone 48968 0
+61 2 9351 9747
Fax 48968 0
Email 48968 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
SourceTitleYear of PublicationDOI
EmbaseThe application of the maximal opposition therapy approach to an Arabic-speaking child.2019https://dx.doi.org/10.1016/j.jcomdis.2019.105913
N.B. These documents automatically identified may not have been verified by the study sponsor.