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

Sponsor

The University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT01765348

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Language Impairment in School-years	Behavioral: Syntax treatment via sentence-combining method Behavioral: Syntax treatment managed by narrative-based treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Changes from baseline in language scores based on a standardized language assessment [Children were followed up to 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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