Language Impairment in School-yearsNCT01765348
Evaluating Treatment Efficacy of Two Syntactic Treatment Procedures for Children With Specific Language Impairment (SLI): A Randomized Controlled Trial
A study testing Syntax treatment via sentence-combining method and Syntax treatment managed by narrative-based treatment in people with Language Impairment in School-years, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Language Impairment in School-years
- What is being tested?
- Syntax treatment via sentence-combining method and Syntax treatment managed by narrative-based treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- children with sensory impairment and other diagnosed developmental disorders such as autism.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Language Impairment in School-years
- Being tested
- Syntax treatment via sentence-combining method, Syntax treatment managed by narrative-based treatment
- Keywords
- language impairment, language disorders, syntax treatment, narrative-based treatment
- Medical subject headings
- Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syntax treatment via sentence-combining methodBehavioural
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.
Syntax treatment managed by narrative-based treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sentence combining | Experimental | Not described Receives: Behavioral: Syntax treatment via sentence-combining method |
| Narrative based method | Active comparator | Not described Receives: Behavioral: Syntax treatment managed by narrative-based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Children were followed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language Impairment in School-yearsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TO Kit Sum, The University of Hong Kong
- Investigators
- Carol K. S. To, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765348
- Sponsor's protocol ID
- HKU 753610H
- Other IDs
- HKU 753610H
- Status last verified
- Jan 2013
- First submitted
- 23 Dec 2012
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Treatment Efficacy of Two Syntactic Treatment Procedures for Children With Specific Language Impairment (SLI): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01765348
- Acronym / sponsor ID
- HKU 753610H
- Conditions
- Language Impairment in School-years
- Keywords
- language impairment, language disorders, syntax treatment, narrative-based treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentence combining | Experimental | Behavioral: Syntax treatment via sentence-combining method |
| Narrative based method | Active comparator | Behavioral: Syntax treatment managed by narrative-based treatment |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- children with sensory impairment and other diagnosed developmental disorders such as autism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syntax treatment via sentence-combining methodSentence 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. | Behavioural | Sentence combining |
| Syntax treatment managed by narrative-based treatmentTarget 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. | Behavioural | Narrative based method |
Primary outcome
Changes from baseline in language scores based on a standardized language assessment
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol K. S. To, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syntax treatment via sentence-combining method and Syntax treatment managed by narrative-based treatment in people with Language Impairment in School-years, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in language scores based on a standardized language assessment (time frame: Children were followed up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.