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CompletedNCT05921188Updated Jun 27, 2025

The Effect of Prior Learning on Word Learning

A Phase 2 interventional study of VAULT Phase 4 in Language Development Disorders, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 2 Years to 4 Years. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by University of Arizona · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
2 Years to 4 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Language Development Disorders

Keywords

  • Late Talkers
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In context

Language Development Disorders

114 studies on the registry are indexed under Language Development Disorders; 47 are open to participants now.

This study's enrollment of 22 is below the median of 71 across 100 interventional studies indexed under Language Development Disorders.

Browse Language Development Disorders studies →

Lead sponsor

University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 4 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
22 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralVAULT Phase 4

    Children will receive an input-based word learning treatment that is designed based on principles of statistical learning.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Change from baseline through treatment, which will average an 8-week time frame.

  2. 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.

    Time frame: Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.

Secondary outcomes

  1. Post Treatment Retention

    The investigators will use probe data and parental report to determine how many of the words the child retained from treatment.

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

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Study locations

1 site
  • University of Arizona
    Tucson, Arizona 85721, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05921188
Lead sponsor
University of Arizona
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Responsible party
Sponsor
First posted
Jun 27, 2023
Start date
Jun 1, 2023
Primary completion
Jun 6, 2025
Completion
Jun 6, 2025
Last update
Jun 27, 2025

Study contacts

Mary Alt, PhD
principal investigator · University of Arizona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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