Building Complex Language

This study has been completed.
Sponsor:
Collaborator:
Rush University
Information provided by (Responsible Party):
Catherine Balthazar, Governors State University
ClinicalTrials.gov Identifier:
NCT01337232
First received: April 13, 2011
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Language Development Disorders
Learning Disorders
Behavioral: Complex sentence treatment protocol
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Building Complex Language: Effect of Treatment and Dosage

Resource links provided by NLM:


Further study details as provided by Governors State University:

Primary Outcome Measures:
  • Changes in Scores on Norm-Referenced and Criterion-Referenced Language Tests [ Time Frame: within one month post treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 31
Study Start Date: April 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 session per week Behavioral: Complex sentence treatment protocol
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.
Experimental: 2 sessions per week Behavioral: Complex sentence treatment protocol
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.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • hearing impairment
  • autism spectrum disorder
  • developmental delay
  • genetic syndrome
  • brain injury
  • cerebral palsy
  • seizure disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337232

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Governors State University
University Park, Illinois, United States, 60484
Sponsors and Collaborators
Governors State University
Rush University
Investigators
Principal Investigator: Catherine H Balthazar, PhD Governors State University
Principal Investigator: Cheryl M Scott, PhD Rush University Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Catherine Balthazar, Chair, Department of Communication Disorders, Governors State University
ClinicalTrials.gov Identifier: NCT01337232     History of Changes
Other Study ID Numbers: 1 R15 DC011165-01
Study First Received: April 13, 2011
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Governors State University:
language development disorders
learning disorders
sentences
syntax
school-age
language

Additional relevant MeSH terms:
Language Development Disorders
Learning Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2014