- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06250101
Training Grammar With Meaning
Study 5: Effects of Semantic Support
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children between 4 years, 0 months and 6 years 11 months are eligible. A diagnosis of developmental language disorders will be confirmed as normal nonverbal cognitive function, passing a pure-tone audiometric screening, and a test score consistent with developmental language disorder on a standardized language test, and parent report of no other diagnosed handicapping condition. Speech skills and vocabulary skills will be described via standardized testing.
Children enrolled in treatment are seen for up to 28 consecutive weekdays. The study starts with three days of baseline assessment of morpheme use for potential treatment targets. Two are selected for study, with one treated and one tracked over the course of treatment. Treatment is embedded in child-friendly activities like games, book reading, and craft activities. Children are prompted to use the treated morpheme in conversation. Immediately following this attempt, the treating clinician repeats the child's utterance, correcting any ungrammatical forms. Half of the children will also receive explanations of what the key words in sentences mean (e.g., to twirl means to turn around fast). Generalization to untreated contexts is assessed 2-3 times weekly. Retention of learning is measured about six weeks after the end of treatment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elena Plante, PhD
- Phone Number: 520-621-5080
- Email: eplante@arizona.edu
Study Contact Backup
- Name: Rebecca Vance, MS
- Phone Number: 520-626-9332
- Email: rbvance@arizona.edu
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85721
- Recruiting
- The University of Arizona
-
Contact:
- Elena Plante, PhD
- Phone Number: 520-621-5080
- Email: eplante@arizona.edu
-
Contact:
- Rebecca Vance, MS
- Phone Number: 520-626-9332
- Email: rbvance@arizona.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Language scores consistent with a developmental language disorder nonverbal cognitive scores consistent with normal-range intellectual functioning
Exclusion Criteria:
hearing loss Intellectual disability Other handicapping conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Grammar treatment including semantic support
Children receiving grammatical treatment will also receive a simple explanation concerning the meaning of verbs used to elicit grammatical forms.
|
In the context of child-friendly activities, the clinician prompts the child to attempt to use the grammatical form targeted in the treatment.
The clinician immediately restates the child's attempt (i.e., the recast), correcting any ungrammatical elements.
Clinicians elicit and recasts 24 utterances per session.
|
Active Comparator: Grammatical treatment excluding semantic support
Children receiving grammatical treatment will not receive any explanation concerning the meaning of verbs used to elicit grammatical forms.
|
In the context of child-friendly activities, the clinician prompts the child to attempt to use the grammatical form targeted in the treatment.
The clinician immediately restates the child's attempt (i.e., the recast), correcting any ungrammatical elements.
Clinicians elicit and recasts 24 utterances per session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the use of treated grammatical forms in untreated contexts
Time Frame: 2-3 days per week over 6 weeks
|
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions.
This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'generalization probe'.
Change is assessed throughout the treatment period.
|
2-3 days per week over 6 weeks
|
Change in the use of grammatical forms in untreated contexts
Time Frame: 2-3 days per week over 6 weeks
|
Clinicians elicit ten uses of the untrained grammatical form using toys, activities, and vocabulary with-held from treatment sessions.
This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'generalization probe'.. Change is assessed throughout the treatment period.
|
2-3 days per week over 6 weeks
|
Retention of trained grammatical forms
Time Frame: 2-3 days per week over 6 weeks
|
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions .
This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'generalization probe'.
|
2-3 days per week over 6 weeks
|
Retention of untrained grammatical forms
Time Frame: 2-3 days per week over 6 weeks
|
Clinicians elicit ten uses of the untrained grammatical form using toys, activities, and vocabulary with-held from treatment sessions.
This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'retention probe'.
|
2-3 days per week over 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spontaneous use of trained grammatical forms
Time Frame: 5 days a week for six weeks
|
The number of times over the course of treatment that children correctly use their treated form unprompted.
|
5 days a week for six weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Plante E, Ogilvie T, Vance R, Aguilar JM, Dailey NS, Meyers C, Lieser AM, Burton R. Variability in the language input to children enhances learning in a treatment context. Am J Speech Lang Pathol. 2014 Nov;23(4):530-45. doi: 10.1044/2014_AJSLP-13-0038.
- Meyers-Denman CN, Plante E. Dose Schedule and Enhanced Conversational Recast Treatment for Children With Specific Language Impairment. Lang Speech Hear Serv Sch. 2016 Oct 1;47(4):334-346. doi: 10.1044/2016_LSHSS-15-0064.
- Plante E, Mettler HM, Tucci A, Vance R. Maximizing Treatment Efficiency in Developmental Language Disorder: Positive Effects in Half the Time. Am J Speech Lang Pathol. 2019 Aug 9;28(3):1233-1247. doi: 10.1044/2019_AJSLP-18-0285. Epub 2019 Jul 25.
- Sweeney L, Plante E, Mettler HM, Hall J, Vance R. Less Versus More: The Effect of Recast Length in Treatment of Grammatical Errors. Lang Speech Hear Serv Sch. 2024 Jan 11;55(1):152-165. doi: 10.1044/2023_LSHSS-23-00049. Epub 2023 Dec 1.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLD-Tx2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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