NCT05921214

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

June 14, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
2 years until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

June 14, 2023

Last Update Submit

June 23, 2025

Conditions

Keywords

Late Talkers

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Post Treatment Retention

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

Study Arms (2)

Familiar Words

EXPERIMENTAL

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

Less-Familiar Words

ACTIVE COMPARATOR

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

Interventions

VAULT Phase 5BEHAVIORAL

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

Familiar WordsLess-Familiar Words

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Native English Speaking
  • Pass pure tone hearing screening or medical report of normal hearing
  • Years of age
  • MCDI expressive scale \<10th percentile

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

RECRUITING

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mary Alt, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Alt, PhD

CONTACT

Nora Evans-Reitz, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The late talkers and their caregivers will not explicitly be told what condition their child is in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Using treatment effect sizes, children will be compared to themselves (treatment words v. control words) and across groups (familiar word group v. less-familiar word group).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 27, 2023

Study Start

June 10, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations