Language Impairment in School-years Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | December 2012 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years to 12 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Carol K. S. TO | Hong Kong | HK |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Hong Kong |
Hong Kong,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes from baseline in language scores based on a standardized language assessment | 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. | Children were followed up to 6 months | No |