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

Primary Purpose

Language Impairment in School-years

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Syntax treatment via sentence-combining method
Syntax treatment managed by narrative-based treatment
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Language Impairment in School-years focused on measuring language impairment, language disorders, syntax treatment, narrative-based treatment

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carol K. S. TO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sentence combining

Narrative based method

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 23, 2012
Last Updated
January 8, 2013
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01765348
Brief Title
Evaluating Treatment Efficacy of Two Syntactic Treatment Procedures for Children With Specific Language Impairment (SLI): A Randomized Controlled Trial
Official Title
Evaluating Treatment Efficacy of Two Syntactic Treatment Procedures for Children With Specific Language Impairment (SLI): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Impairment in School-years
Keywords
language impairment, language disorders, syntax treatment, narrative-based treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sentence combining
Arm Type
Experimental
Arm Title
Narrative based method
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Syntax treatment via sentence-combining method
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Syntax treatment managed by narrative-based treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline in language scores based on a standardized language assessment
Description
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.
Time Frame
Children were followed up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol K. S. To, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carol K. S. TO
City
Hong Kong
State/Province
HK
ZIP/Postal Code
HK
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

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

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