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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [1] 289354 0
Kuwait University
Cultural Relations Office
P.O Box 5969, Safat 13060, Kuwait
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
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
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
Aim:
The primary concern of the proposed study is to investigate the efficacy and the ability to apply the phonological contrast therapy approach in Arabic, and to evaluate the effect of the phonological contrast therapy approach on speech accuracy and consistency of word production for children with consistent speech-sound disorder in Arabic.
Hypothesis:
Arabic speaking children with speech disorders will benefit from contrast therapy approach delivered in Arabic Language.
Background information:
Treating consistent speech disorders in children with phonological contrast therapy has proven its efficacy in English (Baker & McLeod, 2011). According to the literature, there are four major contrastive approaches for treating speech disorders: minimal pairs (Weiner, 1981), multiple oppositions (Williams, 2000 & 2003), maximal oppositions (Gierut, 1990) and empty set (Gierut, 1991). The positive benefits of these treatments have been widely documented. Moreover, there are some studies that focused on comparing between these treatment types in an attempt to find out which method is the most effective one (Gierut, 2001) which reflected the complexity of the population. According to Crosbie et.al (2005), phonological contrast approaches target speech error patterns and help with recognizing a child’s linguistic system in order to increase recognition of the similarities and differences of sounds and how these mark differences in meaning. Overall, most of the research that investigated the efficacy of the phonological contrast therapy approach resulted in children with consistent errors benefiting most from phonological contrast therapy. The pilot study on a single case study design has revealed some interesting results including a significant improvement with child’s production accuracy following treatment presented in minimal pairs in Arabic. However, the data elicited from the pilot study is very preliminary as there is no available literature provides any information regarding speech treatment in Arabic. More sample size is required to validate the effectiveness of the treatment in monolingual Arabic speaking children.
Method:
Recruitment
Participants will be recruited from the patients’ waiting list in Salem Al-Ali Centre for Speech and Hearing in Kuwait, and from Hospital of Natural Medicine.
Participants
This study will involve 20 children of ages 3-7. 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.
Procedures:
The participants will complete the following assessments test in order to fulfill the inclusion criteria: Receptive language assessment using an Arabic Standardized version of Peabody Picture Vocabulary Test (Abu Alam & Hadi, 1998); oral motor screening test from the Diagnostic Evaluation of Articulation and Phonology test (Dodd, Hua, Crosbie, Holm, & Ozanne, 2002) ; and pure-tone hearing screening (ASHA, 1997). A 58-word picture naming Arabic articulation test will be used to evoke responses representing the initial, medial, and final consonants of Arabic Lebanese dialect (Amayreh, 2000). These tests will be conducted in Salem Al-Ali centre and the at the Hospital of Natural Medicine. The tests will be conducted over 2 sessions. Parents will be encouraged to observe these sessions from the associated observation rooms.
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
mals1486@uni.sydney.edu.au
Contact person for public queries
Name 48967 0
A/Prof 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
tricia.mccabe@sydney.edu.au
Contact person for scientific queries
Name 48968 0
A/Prof 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
tricia.mccabe@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary