The Effect of Semantic Support on Word Learning

Language Development Disorders Clinical Trial

Official title:

Identification of Treatment Parameters That Maximize Language Treatment Efficacy For Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05921214
• Other study ID #: Late Talker Phase 5
• Secondary ID: 2R01DC015642-06
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2023
• Source: University of Arizona
• Contact: Mary Alt, PhD
• Phone: 520-626-6180
• Email: malt[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Language Development Disorders

Intervention

Behavioral:
• VAULT Phase 5
This is an input-based vocabulary learning treatment based on principles of statistical learning.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Institute on Deafness and Other Communication Disorders (NIDCD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Effect Size	The investigators will count the number of spontaneous and probed productions of target and control words and calculate a treatment effect size (d).	Change from baseline through treatment, which will average an 8-week time frame.
Primary	Number/Rate of Words Learned	The investigators will measure the number of words learned and rate of words learned as reported by the parent on the MCDI starting prior to treatment, and measured during, immediately following, and 4-6 weeks after treatment.	Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
Secondary	Post Treatment Retention	The investigators will use probe data and parental report to determine how many words the child retained from treatment.	Change from end of treatment to follow up, which will average 4-6 weeks.