- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05953077
The Effect of Prior Learning on Treatment of Morpheme Errors
January 23, 2024 updated by: University of Arizona
This is a small-scale treatment study designed to determine which teaching methods result in the best learning.
Treatment focuses on helping children with a developmental language disorder learn parts of grammar.
Preschool children will receive assessments to determine whether they have a developmental language disorder and what parts of grammar they have not mastered.
Children will receive one-on-one behavioral treatment over a six week period.
Half of the children will be first taught a grammatical form they sometimes use and then one they rarely use.
The other half will start with a grammatical form they rarely use.
The study seeks to determine whether starting with something children sometimes use correctly (an easier part of speech) will speed later learning of something that is harder for them.
The children's ability to use the grammatical forms taught to them will be assessed throughout the treatment period and approximately six weeks after treatment ends.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
- University of Arizona
-
Contact:
- Elena Plante, PhD
- Phone Number: 520-621-5080
- Email: eplante@arizona.edu
-
Contact:
- Rebecca Vance, PhD
- Phone Number: 520-626-9332
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Native English speaking
- Passed a pure-tone hearing screening
- 4-6 years of age
- SPELT-P2 (language) test score of < 87
- K-ABC-II Nonverbal Scale (cognition) test score of >75
- Sufficient morpheme errors to serve as treatment and control targets
- Articulations skills sufficient to judge use of language targets
- Able to attend treatment daily
Exclusion Criteria:
- Parent report of other handicapping conditions
- Clinical signs of other disorders
- Enrolled in outside treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Easy first
Children are treated for an emergent grammatical form that is used correctly at least 60% during three pre-treatment probe sessions.
This form is treated until children generalize it's use an average of 90% or more across 3 probe sessions.
Their treatment target is then switched to a grammatical form that is used less than 30% correct across 3 pre-treatment probe sessions.
|
The treatment procedure uses 24 treatment doses embedded into child-friendly activities (crafts, book reading, play).
Each each consists of a clinician eliciting use of a targeted grammatical form, a child's attempt (correct or incorrect) to use that form, and an immediate clinician repetition of the child's attempt (a recast), correcting any ungrammatical elements as needed.
Clinicians must also attempt to gain the child's attention before providing the recast.
Treatment sessions are approximately 30 minutes in duration.
|
Active Comparator: Hard first
Children are treated for a grammatical form that is used accurately less than 30% of the time during 3 pre-treatment probe sessions.
This form is treated until children generalize it's use an average of 90% or more across 3 probe sessions.
Their treatment target is then switched to a grammatical form that is used less than 30% correct across 3 pre-treatment probe sessions.
|
The treatment procedure uses 24 treatment doses embedded into child-friendly activities (crafts, book reading, play).
Each each consists of a clinician eliciting use of a targeted grammatical form, a child's attempt (correct or incorrect) to use that form, and an immediate clinician repetition of the child's attempt (a recast), correcting any ungrammatical elements as needed.
Clinicians must also attempt to gain the child's attention before providing the recast.
Treatment sessions are approximately 30 minutes in duration.
|
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: 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.
Change is assessed throughout the treatment period.
|
3 days per week over 6 weeks
|
Change in the use of grammatical forms in untreated contexts
Time Frame: 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.
Change is assessed throughout the treatment period.
|
3 days per week over 6 weeks
|
Retention of trained grammatical forms
Time Frame: One session, approximately 6 weeks after treatment concludes.
|
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions.
|
One session, approximately 6 weeks after treatment concludes.
|
Retention of untrained grammatical forms
Time Frame: One session, approximately 6 weeks after treatment concludes.
|
Clinicians elicit ten uses of the untrained grammatical form using toys, activities, and vocabulary with-held from treatment sessions.
|
One session, approximately 6 weeks after treatment concludes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in spontaneous use
Time Frame: 5 sessions a week over 6 weeks.
|
The number of unprompted use of the trained grammatical form that occurs during treatment sessions.
Change is measured relative to baseline.
|
5 sessions a week over 6 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 7, 2023
Primary Completion (Estimated)
August 30, 2024
Study Completion (Estimated)
January 30, 2025
Study Registration Dates
First Submitted
June 9, 2023
First Submitted That Met QC Criteria
July 11, 2023
First Posted (Actual)
July 19, 2023
Study Record Updates
Last Update Posted (Estimated)
January 25, 2024
Last Update Submitted That Met QC Criteria
January 23, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLD-Tx1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data, including clinical test scores and outcome measures, are shared in publications and presentations.
Other study data is provided by request from the study PI.
IPD Sharing Time Frame
Data is available for sharing after initial publication and for a minimum of 5 years after publication.
IPD Sharing Access Criteria
Secondary use must be consistent with the intent of the original consent document.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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