Clinical trial NCT05921214: The Effect of Semantic Support on Word Learning
Official title: Identification of Treatment Parameters That Maximize Language Treatment Efficacy For Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Language Development Disorders
Keywords: Late Talkers
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2023-06-27
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using treatment effect sizes, children will be compared to themselves (treatment words v. control words) and across groups (familiar word group v. less-familiar word group).
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare word learning outcomes in late talking toddlers who are taught different types of words. The main question it aims to answer is if teaching words that come from categories that children already know (e.g., animals) will aid overall word learning. Children will take part in the Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment and be taught words from more familiar or less familiar categories to see which group learns more words overall.

Detailed description: Children will be assigned to either the familiar or less-familiar word group. All children will receive 8 weeks of Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment (2x/wk for 30 minutes each session). The investigators will measure how well children learn the words they are taught as well as the words that are in the environment, but not explicitly taught (control words). This will help us know if their learning is due to treatment or maturation. The investigators will compare children to themselves (taught words v. control words) to ensure that the overall treatment is working. Then, the investigators will compare children in the familiar word group to children in the less-familiar word group to see which group learns more overall.

Eligibility criteria: Inclusion Criteria:

* Native English Speaking
* Pass pure tone hearing screening or medical report of normal hearing
* 2-3 Years of age
* MCDI expressive scale \<10th percentile

Exclusion Criteria:

* Parental report of other diagnoses
* Enrolled in concurrent treatment elsewhere
* Nonverbal IQ \<75 as measured by the Bayley scales
* Parents unable to consistently bring child to treatment sessions

Primary outcomes:
measure: Treatment Effect Size
timeFrame: Change from baseline through treatment, which will average an 8-week time frame.
measure: Number/Rate of Words Learned
timeFrame: Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
Secondary outcomes:
measure: Post Treatment Retention
timeFrame: Change from end of treatment to follow up, which will average 4-6 weeks.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Mary Alt, PhD
role: PRINCIPAL_INVESTIGATOR
References: