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Evaluating Treatment Efficacy of Two Syntactic Treatment Procedures for Children With Specific Language Impairment (SLI): A Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TO Kit Sum, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01765348
First received: December 23, 2012
Last updated: January 8, 2013
Last verified: January 2013

December 23, 2012
January 8, 2013
March 2012
August 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01765348 on ClinicalTrials.gov Archive Site
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Evaluating Treatment Efficacy of Two Syntactic Treatment Procedures for Children With Specific Language Impairment (SLI): A Randomized Controlled Trial
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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Language Impairment in School-years
  • Behavioral: Syntax treatment via sentence-combining method

    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.

  • Behavioral: Syntax treatment managed by narrative-based treatment
    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.
  • Experimental: Sentence combining
    Intervention: Behavioral: Syntax treatment via sentence-combining method
  • Active Comparator: Narrative based method
    Intervention: Behavioral: Syntax treatment managed by narrative-based treatment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
December 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT01765348
HKU 753610H, HKU 753610H
No
TO Kit Sum, The University of Hong Kong
The University of Hong Kong
Not Provided
Principal Investigator: Carol K. S. To, PhD The University of Hong Kong
The University of Hong Kong
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP