The Effect of Prior Learning 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: Recruiting

Administrative data

• NCT number: NCT05921188
• Other study ID #: Late Talker Phase 4
• Secondary ID: 2R01DC015642-06
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2023
• Est. completion date: June 2025

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 two treatment conditions for late talking toddlers. In 8 weeks of word learning treatment, toddlers will be taught words that sound more like the words they already know or sound less like the words they already know. The investigators see which group learns more, to understand if choosing words that let children use the knowledge they already have helps with learning.

Description:

Late talking toddlers will be assigned to be in the More Familiar Sounds condition or the Less Familiar Sounds condition. Both groups will receive 8 weeks of Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment (2x/week for 30 minutes per session) using their words. The investigators will compare learning within children (taught words v. control words that are not explicitly taught) to make sure the learning that is happening is due to the treatment and not just maturation. The investigators will compare across groups to see if the group treated with More Familiar Sounding words learns more than the group treated with Less Familiar Sounding words.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• 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 at start of study

• MCDI expressive scales <10th percentile

Exclusion Criteria:

• Parental reports 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 4
Children will receive an input-based word learning treatment that is designed based on principles of statistical learning.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

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 the 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 the 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 of the words the child retained from treatment.	Change from end of treatment to follow up, which will average 4-6 weeks.