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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06250101
Other study ID # DLD-Tx2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 17, 2024
Est. completion date January 30, 2026

Study information

Verified date January 2024
Source University of Arizona
Contact Rebecca Vance, MS
Phone 520-626-9332
Email rbvance@arizona.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will enroll children between the ages of 4 and 6 years of age who exhibit significant difficulty developing language skills without any other handicapping conditions. Children will receive standardized language, hearing, and cognitive testing to confirm a diagnosis of developmental language disorder. Children will be enrolled in a half-day summer camp program for six weeks during which they will receive treatment designed to improve their language skills. Children will be seen again approximately six weeks after the end of treatment to determine how much learning they have retained.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date January 30, 2026
Est. primary completion date August 30, 2025
Accepts healthy volunteers No
Gender All
Age group 48 Months to 83 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Enhanced Conversational Recast treatment
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.

Locations

Country Name City State
United States The University of Arizona Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 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
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. 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
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 . 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
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. 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 Spontaneous use of trained grammatical forms The number of times over the course of treatment that children correctly use their treated form unprompted. 5 days a week for six weeks
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