Building Complex Language

Sponsor

Governors State University (Other)

Overall Status

Completed

CT.gov ID

NCT01337232

Collaborator

Rush University (Other)

Enrollment

Locations

Arms

Duration (Months)

15.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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 or Disease	Intervention/Treatment	Phase
Language Development Disorders Learning Disorders	Behavioral: Complex sentence treatment protocol	Phase 1/Phase 2

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

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Building Complex Language: Effect of Treatment and Dosage

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Changes in Scores on Norm-Referenced and Criterion-Referenced Language Tests [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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