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Clinical Trials/NCT05921214
NCT05921214
Recruiting
N/A

Identification of Treatment Parameters That Maximize Language Treatment Efficacy For Children

University of Arizona1 site in 1 country32 target enrollmentJune 10, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Language Development Disorders
Sponsor
University of Arizona
Enrollment
32
Locations
1
Primary Endpoint
Treatment Effect Size
Status
Recruiting
Last Updated
10 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2025
End Date
December 1, 2026
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Treatment Effect Size

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

The investigators will count the number of spontaneous and probed productions of target and control words and calculate a treatment effect size (d).

Number/Rate of Words Learned

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

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.

Secondary Outcomes

  • Post Treatment Retention(Change from end of treatment to follow up, which will average 4-6 weeks.)

Study Sites (1)

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