Language Development DisordersPhase 1/2NCT01337232
Building Complex Language
A Phase 1/2 study testing Complex sentence treatment protocol in people with Language Development Disorders and Learning Disorders, run by Governors State University at 2 sites in United States.
Trial summary
This study is designed to examine how much therapy is needed in order to make significant gains in knowledge and use of complex sentences. Students will be randomly placed in individual treatment sessions that take place either once or twice per week for nine weeks. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Language Development Disorders, Learning Disorders
- What is being tested?
- Complex sentence treatment protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Sep 2013
- Phase
- Phase 1/2
- 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 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Disability: documented language or learning disorder
- Nonverbal IQ within 1 standard deviation of mean for age
- Oral language score 1 or more standard deviations below mean for age
- Problem areas: difficulty with language in any of the following areas - reading comprehension, writing, following verbal instructions, verbal expression
Who cannot join
- hearing impairment
- autism spectrum disorder
- developmental delay
- genetic syndrome
- brain injury
- cerebral palsy
- seizure disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
Governors State University
University Park, Illinois, 60484
About this study
Official title: Building Complex Language: Effect of Treatment and Dosage
This study is designed to examine how much therapy is needed in order to make significant gains in knowledge and use of complex sentences. Students will be randomly placed in individual treatment sessions that take place either once or twice per week for nine weeks. All will receive the same type of treatment, which consists of a focused series of oral and written language activities. While it is anticipated that students in both groups will benefit from treatment, we hypothesize that the twice-weekly session frequency will have a significantly greater impact on level of performance and maintenance of skills after treatment.
Read the detailed description
The objective of this project is to examine outcomes of a treatment intervention designed to increase functional use of complex (multi-clausal) sentences in school-age students with primary language impairments that impact literacy and academic achievement. The treatment protocol includes: (1) three types of complex sentences (adverbial, relative, object complement), (2) encounters with complex sentences in real texts and across all modalities (speaking, listening, reading, writing, and (3) activities that engage metalinguistic understanding of complex sentences. Specific objectives are to (1) document treatment effect in terms of size and scope of impact in decontextualized as well as naturalistic language contexts, (2) document the effect of treatment intensity (dosage), (3) explore effects of sentence complexity subtype and treatment outcomes, and (4) explore relationships between treatment outcomes and participant variables (pre-treatment knowledge of complex sentences, verbal working memory, and non-verbal cognition).
The study will utilize two designs. Approximately 10 participants per year will complete the treatment, randomly assigned to one of two treatment levels. As each participant finishes, efficacy and effect size will be measured using a multiple-baseline single-subject design. Once all 30 participants have completed the treatment, effect size and the impact of dosage (treatment intensity) will be evaluated using a pretest-posttest group design, and correlations between participant characteristics and individual patterns of performance will be carefully described and analyzed.
This study targets school-age students with a Speech-Language Impairment and/or a Specific Learning Disability between the ages of 10 and 14 who are receiving services from a Speech-Language Pathologist (SLP) for one or more higher-level language behaviors. It is expected that participants will demonstrate higher levels of fluency with complex sentences compared with pretreatment baseline levels and that treatment effects will be reflected in several modalities and in naturalistic language contexts.
- Conditions
- Language Development Disorders, Learning Disorders
- Being tested
- Complex sentence treatment protocol
- Keywords
- language development disorders, learning disorders, sentences, syntax, school-age, language
- Medical subject headings
- Language Development Disorders, Learning Disabilities, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex sentence treatment protocolBehavioural
Treatment: listening, speaking, reading, and writing activities that teach three types of complex sentences. Individual sessions are 40 minutes in length, delivered by or under the supervision of a certified, trained speech-language pathologist.
| Study group | Role | What they receive |
|---|---|---|
| 1 session per week | Active comparator | Not described Receives: Behavioral: Complex sentence treatment protocol |
| 2 sessions per week | Experimental | Not described Receives: Behavioral: Complex sentence treatment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Scores on Norm-Referenced and Criterion-Referenced Language Tests
A battery of language comprehension and production measures given pre-treatment will be administered again following treatment. The measures include broad norm-referenced oral and written language tests and a specific criterion-referenced measure of complex sentence production.
Measured: within one month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language Development DisordersStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Governors State University
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University
- Responsible party
- Principal investigator, Catherine Balthazar, Governors State University
- Investigators
- Catherine H Balthazar, PhD, Principal investigator, Governors State UniversityCheryl M Scott, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337232
- Sponsor's protocol ID
- 1R15DC011165-01
- Status last verified
- Nov 2013
- First submitted
- 13 Apr 2011
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Complex Language: Effect of Treatment and Dosage
- ClinicalTrials.gov ID
- NCT01337232
- Acronym / sponsor ID
- 1R15DC011165-01
- Conditions
- Language Development Disorders, Learning Disorders
- Keywords
- language development disorders, learning disorders, sentences, syntax, school-age, language
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Governors State UniversityUniversity, hospital or other
- Collaborators
- Rush University
- Study start
- Apr 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Apr 2011 (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.
This study is designed to examine how much therapy is needed in order to make significant gains in knowledge and use of complex sentences. Students will be randomly placed in individual treatment sessions that take place either once or twice per week for nine weeks. All will receive the same type of treatment, which consists of a focused series of oral and written language activities. While it is anticipated that students in both groups will benefit from treatment, we hypothesize that the twice-weekly session frequency will have a significantly greater impact on level of performance and maintenance of skills after treatment.
Detailed description
The objective of this project is to examine outcomes of a treatment intervention designed to increase functional use of complex (multi-clausal) sentences in school-age students with primary language impairments that impact literacy and academic achievement. The treatment protocol includes: (1) three types of complex sentences (adverbial, relative, object complement), (2) encounters with complex sentences in real texts and across all modalities (speaking, listening, reading, writing, and (3) activities that engage metalinguistic understanding of complex sentences. Specific objectives are to (1) document treatment effect in terms of size and scope of impact in decontextualized as well as naturalistic language contexts, (2) document the effect of treatment intensity (dosage), (3) explore effects of sentence complexity subtype and treatment outcomes, and (4) explore relationships between treatment outcomes and participant variables (pre-treatment knowledge of complex sentences, verbal working memory, and non-verbal cognition).
The study will utilize two designs. Approximately 10 participants per year will complete the treatment, randomly assigned to one of two treatment levels. As each participant finishes, efficacy and effect size will be measured using a multiple-baseline single-subject design. Once all 30 participants have completed the treatment, effect size and the impact of dosage (treatment intensity) will be evaluated using a pretest-posttest group design, and correlations between participant characteristics and individual patterns of performance will be carefully described and analyzed.
This study targets school-age students with a Speech-Language Impairment and/or a Specific Learning Disability between the ages of 10 and 14 who are receiving services from a Speech-Language Pathologist (SLP) for one or more higher-level language behaviors. It is expected that participants will demonstrate higher levels of fluency with complex sentences compared with pretreatment baseline levels and that treatment effects will be reflected in several modalities and in naturalistic language contexts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 session per week | Active comparator | Behavioral: Complex sentence treatment protocol |
| 2 sessions per week | Experimental | Behavioral: Complex sentence treatment protocol |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Disability: documented language or learning disorder
- Nonverbal IQ within 1 standard deviation of mean for age
- Oral language score 1 or more standard deviations below mean for age
- Problem areas: difficulty with language in any of the following areas - reading comprehension, writing, following verbal instructions, verbal expression
Key exclusion criteria (7 listed)
- hearing impairment
- autism spectrum disorder
- developmental delay
- genetic syndrome
- brain injury
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 |
|---|---|---|
| Complex sentence treatment protocolTreatment: listening, speaking, reading, and writing activities that teach three types of complex sentences. Individual sessions are 40 minutes in length, delivered by or under the supervision of a certified, trained speech-language pathologist. | Behavioural | 1 session per week, 2 sessions per week |
Primary outcome
Changes in Scores on Norm-Referenced and Criterion-Referenced Language Tests
Time frame: within one month post treatment
A battery of language comprehension and production measures given pre-treatment will be administered again following treatment. The measures include broad norm-referenced oral and written language tests and a specific criterion-referenced measure of complex sentence production.
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 25 Nov 2013.
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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.
Catherine H Balthazar, PhD principal investigator
Governors State University
Cheryl M Scott, PhD principal investigator
Rush University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Complex sentence treatment protocol in people with Language Development Disorders and Learning Disorders, run by Governors State University at 2 sites in United States.
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 4 inclusion and 7 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 in Scores on Norm-Referenced and Criterion-Referenced Language Tests (time frame: within one month post treatment). 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 25 Nov 2013.