- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01765348
Evaluating Treatment Efficacy of Two Syntactic Treatment Procedures for Children With Specific Language Impairment (SLI): A Randomized Controlled Trial
Specific-language-impairment (SLI) is defined as a significant disorder in language development, which affects one's daily functioning, but not attributable to sensory, intellectual or neuropsychological deficit. Children with SLI make up one of the largest subgroups of students with special educational needs (SEN) in Hong Kong. Without appropriate intervention, SLI may persist into adolescence and lead to long-term literacy difficulties and social rejection, which were found to be associated with societal problems like unemployment and crime commitment. Among the language domains, syntax/grammar has been viewed as a core deficit in these children. Speech-Language-Pathologists (SLPs) often provide intervention on this aspect for them. However, very few intervention efficacy studies could be identified.
Without pertinent research evidence, clinical-decision-making in treatment approach selection may be dubious. This study aims to evaluate the efficacy of two procedures for syntax intervention, namely the Sentence-Combining (SC) and Narrative-Based (NAR) procedures using a randomized-controlled-trial (RCT) design. These two procedures have been indicated to be effective in previous case reports and expert opinions. By using the rigorous study design of RCT, this study provides stronger evidence to support clinicians in determining the most effective treatment procedure. To achieve sufficient statistical power to detect the treatment difference, 52 children with SLI will be recruited and randomly assigned to one of the treatment groups. The primary outcome will be measured by a standardized language assessment. Intention-to-treat analysis will be employed. Pre- and post-treatment scores on the outcomes will be subject to analyses of covariance with the pre-treatment scores as the covariate.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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HK
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Hong Kong, HK, Hong Kong, HK
- Carol K. S. TO
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children in school years who were diagnosed as language with or with speech impairment by a qualified speech therapist; and
- children failed in a standardized language assessment
Exclusion Criteria:
- children with sensory impairment and other diagnosed developmental disorders such as autism.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sentence combining
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Sentence combining method is a discrete trial method that teaches children to form complex sentences of a same structure through drilling and modeling. Treatments are conduced by school-speech therapist once two weeks for 8 sessions. |
ACTIVE_COMPARATOR: Narrative based method
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Target structures are embedded into narrative stories.
Children are exposed to these stories and are scaffolded to form the target sentence structure through answering questions, cloze passage and story retell.
Treatment are conduced by school-speech therapist once two weeks for 8 sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in language scores based on a standardized language assessment
Time Frame: Children were followed up to 6 months
|
All the children were followed for about 6 months in the middle of the school year when they received regular therapy from their school speech-therapists.
Children's language skills were assessed by research speech therapists using a standardized language assessment pre and post treatment.
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Children were followed up to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carol K. S. To, PhD, The University of Hong Kong
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKU 753610H (OTHER_GRANT: Hong Kong General Research Fund)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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