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Clinical Trials/NCT05921188
NCT05921188
Completed
Phase 2

Identification of Treatment Parameters That Maximize Language Treatment Efficacy for Children

University of Arizona1 site in 1 country22 target enrollmentJune 1, 2023

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Language Development Disorders
Sponsor
University of Arizona
Enrollment
22
Locations
1
Primary Endpoint
Treatment Effect Size
Status
Completed
Last Updated
10 months ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
June 6, 2025
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 at start of study
  • MCDI expressive scales \<10th percentile

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

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 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.

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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