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
  Purpose

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.


Condition Intervention
Language Impairment in School-years
Behavioral: Syntax treatment via sentence-combining method
Behavioral: Syntax treatment managed by narrative-based treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Treatment Efficacy of Two Syntactic Treatment Procedures for Children With Specific Language Impairment (SLI): A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 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.


Enrollment: 52
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sentence combining 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.

Active Comparator: Narrative based method 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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765348

Locations
Hong Kong
Carol K. S. TO
Hong Kong, HK, Hong Kong, HK
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Carol K. S. To, PhD The University of Hong Kong
  More Information

No publications provided

Responsible Party: TO Kit Sum, Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01765348     History of Changes
Other Study ID Numbers: HKU 753610H, HKU 753610H
Study First Received: December 23, 2012
Last Updated: January 8, 2013
Health Authority: The University of Hong Kong: Institutional Review Board

Keywords provided by The University of Hong Kong:
language impairment
language disorders
syntax treatment
narrative-based treatment

Additional relevant MeSH terms:
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014