The Effect of Prior Learning on Word Learning

Identification of Treatment Parameters That Maximize Language Treatment Efficacy for Children

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.

Study Overview

• Status: Completed
• Conditions: Language Development Disorders
• Intervention / Treatment: Behavioral: VAULT Phase 4

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: More Familiar Sounds; Children in this condition will learn new words whose sounds are more like the sounds in the words the child already understands.	Behavioral: VAULT Phase 4; Children will receive an input-based word learning treatment that is designed based on principles of statistical learning.
Active Comparator: Less Familiar Sounds; Children in this condition will learn new words whose sounds are less like the sounds in the words the child already understands.	Behavioral: VAULT Phase 4; Children will receive an input-based word learning treatment that is designed based on principles of statistical learning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Mary Alt, PhD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 6, 2025
• Study Completion (Actual): June 6, 2025

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Late Talkers
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Language Development Disorders
• Other Study ID Numbers: Late Talker Phase 4; 2R01DC015642-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No