Recruiting

Observational Study

Sponsor:

University of Arizona

Code:

NCT05921214

Conditions

Language Development Disorders

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Not accepted

Interventions

VAULT Phase 5

Study Details

Brief 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.

Conditions

Language Development Disorders

Study ID

NCT05921214

Start date

Jun 10, 2025

Status verified date

Jul, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Not accepted

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 Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

VAULT Phase 5

This is an input-based vocabulary learning treatment based on principles of statistical learning.

Primary outcome measure

  • Treatment Effect Size [ Time Frame: Change from baseline through treatment, which will average an 8-week time frame. ]
  • Number/Rate of Words Learned [ Time Frame: Change from Initial Evaluation through Follow-up, which will average a 6-month time frame. ]

Central Contacts and Locations

Central contacts

Mary Alt, PhD

520-626-6180malt@arizona.edu

Nora Evans-Reitz, MS

520-626-6885nevansreitz@arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85721

Contacts

Nora Evans-Reitz, M.S.

520-626-6885nevansreitz@arizona.edu

Cecilia Figueroa, M.S.

520-626-6885cecilm@arizona.edu

Principal Investigator:

Mary Alt, PhD

More Information

Sponsor

University of Arizona

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Late Talkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-07-13.