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The Effect of Semantic Support on Word Learning

Sponsor
University of Arizona (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05921214
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
32
Enrollment
2
Arms
30
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: VAULT Phase 5
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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).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).
Masking:
Double (Participant, Care Provider)
Masking Description:
The late talkers and their caregivers will not explicitly be told what condition their child is in.
Primary Purpose:
Treatment
Official Title:
Identification of Treatment Parameters That Maximize Language Treatment Efficacy For Children
Anticipated Study Start Date :
Jun 1, 2024
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Familiar Words

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
This is an input-based vocabulary learning treatment based on principles of statistical learning.
Active Comparator: Less-Familiar Words

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

Outcome Measures

Primary Outcome Measures

  1. Treatment Effect Size [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).

  2. Number/Rate of Words Learned [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 Outcome Measures

  1. Post Treatment Retention [Change from end of treatment to follow up, which will average 4-6 weeks.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 4 Years
Sexes Eligible for Study:
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

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Arizona
  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Mary Alt, PhD, University of Arizona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arizona
ClinicalTrials.gov Identifier:
NCT05921214
Other Study ID Numbers:
  • Late Talker Phase 5
  • 2R01DC015642-06
First Posted:
Jun 27, 2023
Last Update Posted:
Jun 27, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Arizona
Late Talkers
Additional relevant MeSH terms:
Language Development Disorders

Study Results

No Results Posted as of Jun 27, 2023