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Building Complex Language

NCT ID: NCT01337232

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-09-30

Brief Summary

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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

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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

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Language Development Disorders Learning Disorders

Keywords

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language development disorders learning disorders sentences syntax school-age language

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1 session per week

Group Type ACTIVE_COMPARATOR

Complex sentence treatment protocol

Intervention Type BEHAVIORAL

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.

2 sessions per week

Group Type EXPERIMENTAL

Complex sentence treatment protocol

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University

OTHER

Sponsor Role collaborator

Governors State University

OTHER

Sponsor Role lead

Responsible Party

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Catherine Balthazar

Chair, Department of Communication Disorders

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine H Balthazar, PhD

Role: PRINCIPAL_INVESTIGATOR

Governors State University

Cheryl M Scott, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Governors State University

University Park, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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1R15DC011165-01

Identifier Type: NIH

Identifier Source: org_study_id

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