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Recruiting NCT05921214

The Effect of Semantic Support on Word Learning

No phase Interventional Language Development Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VAULT Phase 5.
Who it may be relevant to
Registry conditions: Language Development Disorders. Basic parameters: 2 years — 4 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Identification of Treatment Parameters That Maximize Language Treatment Efficacy For Children

Overview

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.

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.

Interventions

  • Behavioral VAULT Phase 5
    This is an input-based vocabulary learning treatment based on principles of statistical learning.

Primary outcome measures

  • 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.]
Secondary outcome measures (1)
  • Post Treatment Retention [Time frame: Change from end of treatment to follow up, which will average 4-6 weeks.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Arizona — Tucson

Identifiers

NCT: NCT05921214 · Late Talker Phase 5 · 2R01DC015642-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗