The Effect of Prior Learning on Word Learning

NCT05921188 | Completed Phase 2

• 2 other identifiers: Late Talker Phase 42R01DC015642-06
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Language Development Disorders

Keywords

Late Talkers

Outcome Measures

Primary Outcomes (2)

• Treatment Effect Size

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

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

• Number/Rate of Words Learned

  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.

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

Secondary Outcomes (1)

• Post Treatment Retention

  Change from end of treatment to follow up, which will average 4-6 weeks.

Study Arms (2)

More Familiar Sounds

EXPERIMENTAL

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

Less Familiar Sounds

ACTIVE COMPARATOR

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

Interventions

VAULT Phase 4 BEHAVIORAL

Children will receive an input-based word learning treatment that is designed based on principles of statistical learning.

Less Familiar Sounds; More Familiar Sounds

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Native English Speaking
• Pass pure tone hearing screening or medical report of normal hearing
• Years of age at start of study
• MCDI expressive scales \<10th percentile

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Alt, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The children in the study and their caregivers will not be told which treatment group their child is in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 27, 2023
• Study Start: June 1, 2023
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)