- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05953077
The Effect of Prior Learning on Treatment of Morpheme Errors
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 only be treated for 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
Conditions
Intervention / Treatment
Detailed Description
This is a early-efficacy treatment study designed to determine whether learning of a very low-use grammatical form can be made more efficient by beginning treatment with a form that is partially, but not fully acquired. Children qualify for the study by showing evidence of impaired language skills in the absence of intellectual disability, hearing loss, or other parent-reported handicapping conditions that could affect language skills. Preschool children with a developmental language disorder are provided 24 teaching episodes of Enhanced Conversational Recast daily for up to 25 days. Treatment gains are measured as change from baseline use of probes designed to measure generalization to untreated grammatical forms.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85721
- University of Arizona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Native English speaking
- Passed a pure-tone hearing screening
- 4-6 years of age
- Structured Photographic Expressive Language Test-Preschool 2 (language) test score of < 87
- Kaufman Assessment Battery for Children-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
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 Only
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 for the entire treatment period |
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 |
|---|---|---|
|
The Average Percent Correct Use of Treated Grammatical Forms in Untreated Contexts
Time Frame: Three sessions conducted on three separate days during the sixth week of treatment.
|
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done on each of three days at the end of the treatment period. The percent use calculated as (#correct/10)*100 is calculated over three days at the end of treatment, and these values are averaged for each child. Note that only performance on the hard target is considered in the analysis, even for children previously treated on an easier target. This tests the hypothesis that prior treatment of an easy target speeds learning of a hard target, compared to starting treatment with a hard target. The easy target is not compared to the hard target because, by design, this target to a high level of use, whereas learning levels for the hard target are free to vary. |
Three sessions conducted on three separate days during the sixth week of treatment.
|
|
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 and the percent correct use is calculated as (#correct/10)*100. |
One session, approximately 6 weeks after treatment concludes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Treatment Efficacy
Time Frame: Three sessions conducted on three separate days during the sixth week of treatment.
|
This analysis tests the hypothesis that the treatment in general (collapsed across treatment arms) leads to gains in the use of treated grammatical forms compared with no treatment of grammatical forms. Measures reporting single-participant treatment effect size are typically reported with a Unit of Measure in treatment effect size d. Single-subject treatment effect size d metric reflects gains in morpheme use from baseline levels to the end of treatment, for each individual child. This is calculated for each of the Target and Control morphemes as "Generalization d = ((end treatment percent correct mean - pretreatment percent correct mean)/ (end treatment standard deviation)). Note that the percent correct means are based on the average percent correct use for three sessions pretreatment and during the 6th week of treatment. |
Three sessions conducted on three separate days during the sixth week of treatment.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elena Plante, PhD, University of Arizona
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLD-Tx1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
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.