NCT01337232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2011

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

2.4 years

First QC Date

April 13, 2011

Last Update Submit

November 21, 2013

Conditions

Keywords

language development disorderslearning disorderssentencessyntaxschool-agelanguage

Outcome Measures

Primary Outcomes (1)

  • 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.

    within one month post treatment

Study Arms (2)

1 session per week

ACTIVE COMPARATOR
Behavioral: Complex sentence treatment protocol

2 sessions per week

EXPERIMENTAL
Behavioral: Complex sentence treatment protocol

Interventions

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.

1 session per week2 sessions per week

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • hearing impairment
  • autism spectrum disorder
  • developmental delay
  • genetic syndrome
  • brain injury
  • cerebral palsy
  • seizure disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Governors State University

University Park, Illinois, 60484, United States

Location

MeSH Terms

Conditions

Language Development DisordersLearning DisabilitiesLanguage

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersCommunicationBehavior

Study Officials

  • Catherine H Balthazar, PhD

    Governors State University

    PRINCIPAL INVESTIGATOR
  • Cheryl M Scott, PhD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Communication Disorders

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 18, 2011

Study Start

April 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations