The Effect of Prior Learning on Word Learning

Phase 2

Recruiting

• Conditions: Language Development Disorders
• Interventions: Behavioral: VAULT Phase 4

• Registration Number: NCT05921188
• Lead Sponsor: University of Arizona

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-06-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Less Familiar Sounds	VAULT Phase 4	Children in this condition will learn new words whose sounds are less like the sounds in the words the child already understands.
More Familiar Sounds	VAULT Phase 4	Children in this condition will learn new words whose sounds are more like the sounds in the words the child already understands.

Primary Outcome Measures

Name	Time	Method
Treatment Effect Size	Change from baseline through treatment, which will average an 8-week time frame.	The investigators will count the number of spontaneous and probed productions of target and control words and calculate a treatment effect size (d).
Number/Rate of Words Learned	Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.	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.

Secondary Outcome Measures

Name	Time	Method
Post Treatment Retention	Change from end of treatment to follow up, which will average 4-6 weeks.	The investigators will use probe data and parental report to determine how many of the words the child retained from treatment.

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States