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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05953077
Other study ID # DLD-Tx1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 7, 2023
Est. completion date January 30, 2025

Study information

Verified date January 2024
Source University of Arizona
Contact Elena Plante, PhD
Phone 520-621-5080
Email eplante@arizona.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date January 30, 2025
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 4 Years to 6 Years
Eligibility 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 Design


Intervention

Behavioral:
Conversational recasting
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.

Locations

Country Name City State
United States University of Arizona Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the use of treated grammatical forms in untreated contexts 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
Primary Change in the use of grammatical forms in untreated contexts 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
Primary Retention of trained grammatical forms 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.
Primary Retention of untrained grammatical forms 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 Change in spontaneous use 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.
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