Evaluating Treatment Efficacy of Two Syntactic Treatment Procedures for Children With Specific Language Impairment (SLI): A Randomized Controlled Trial
| Tracking Information | |||||
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| First Received Date ICMJE | December 23, 2012 | ||||
| Last Updated Date | January 8, 2013 | ||||
| Start Date ICMJE | March 2012 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changes from baseline in language scores based on a standardized language assessment [ Time Frame: Children were followed up to 6 months ] [ Designated as safety issue: No ] 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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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01765348 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluating Treatment Efficacy of Two Syntactic Treatment Procedures for Children With Specific Language Impairment (SLI): A Randomized Controlled Trial | ||||
| Official Title ICMJE | Evaluating Treatment Efficacy of Two Syntactic Treatment Procedures for Children With Specific Language Impairment (SLI): A Randomized Controlled Trial | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Language Impairment in School-years | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 52 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Hong Kong | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01765348 | ||||
| Other Study ID Numbers ICMJE | HKU 753610H, HKU 753610H | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | TO Kit Sum, The University of Hong Kong | ||||
| Study Sponsor ICMJE | The University of Hong Kong | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The University of Hong Kong | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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