Clinical trial NCT06250101: Training Grammar With Meaning
Official title: Study 5: Effects of Semantic Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Language Disorders in Children
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 24
Sex: ALL
Minimum age (years): 48
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid single subject/group design
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the use of treated grammatical forms in untreated contexts
timeFrame: 2-3 days per week over 6 weeks
measure: Change in the use of grammatical forms in untreated contexts
timeFrame: 2-3 days per week over 6 weeks
measure: Retention of trained grammatical forms
timeFrame: 2-3 days per week over 6 weeks
measure: Retention of untrained grammatical forms
timeFrame: 2-3 days per week over 6 weeks
Secondary outcomes:
measure: Spontaneous use of trained grammatical forms
timeFrame: 5 days a week for six weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona
state: Arizona
Study officials:
References:
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.
citation: 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.
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.
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.