The Effect of Prior Learning on Word Learning

• Sponsor: University of Arizona (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05921188
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
• Enrollment: 32
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Language Development Disorders	Behavioral: VAULT Phase 4	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The investigators will use treatment effect sizes to compare children to themselves (treatment v. control) and across groups (More Familiar Sounds v. Less Familiar Sounds).The investigators will use treatment effect sizes to compare children to themselves (treatment v. control) and across groups (More Familiar Sounds v. Less Familiar Sounds).
• Masking: Double (Participant, Care Provider)
• Masking Description: The children in the study and their caregivers will not be told which treatment group their child is in.
• Primary Purpose: Treatment
• Official Title: Identification of Treatment Parameters That Maximize Language Treatment Efficacy for Children
• Actual Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2025
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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; Children will receive an input-based word learning treatment that is designed based on principles of statistical learning.
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; Children will receive an input-based word learning treatment that is designed 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 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 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 of the 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85721

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: NCT05921188
• Other Study ID Numbers: Late Talker Phase 4; 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