The Effect of Semantic Support on Word Learning

Identification of Treatment Parameters That Maximize Language Treatment Efficacy For Children

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.

Study Overview

• Status: Recruiting
• Conditions: Language Development Disorders
• Intervention / Treatment: Behavioral: VAULT Phase 5

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Alt, PhD; Phone Number: 520-626-6180; Email: malt@arizona.edu
• Study Contact Backup: Name: Nora Evans-Reitz, MS; Phone Number: 520-626-6885; Email: nevansreitz@arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • Recruiting
      • University of Arizona
      • Contact: Nora Evans-Reitz, M.S.; Phone Number: 520-626-6885; Email: nevansreitz@arizona.edu
      • Contact: Cecilia Figueroa, M.S.; Phone Number: 520-626-6885; Email: cecilm@arizona.edu
      • Principal Investigator: Mary Alt, PhD

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
• 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

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: Familiar Words; In this condition, children will learn new words that come from semantic categories (e.g., animals, body parts) from which they currently understand at least several words.	Behavioral: VAULT Phase 5; This is an input-based vocabulary learning treatment based on principles of statistical learning.
Active Comparator: Less-Familiar Words; In this condition, children will learn new words that come from semantic categories (e.g., animals, body parts) from which they currently understand few or no words.	Behavioral: VAULT Phase 5; This is an input-based vocabulary learning treatment 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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

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 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

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 (Estimated): June 25, 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 5; 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
• product manufactured in and exported from the U.S.: No