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The Effect of Prior Learning on Word Learning

Primary Purpose

Language Development Disorders

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VAULT Phase 4
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Language Development Disorders focused on measuring Late Talkers

Eligibility Criteria

2 Years - 4 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of ArizonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

More Familiar Sounds

Less Familiar Sounds

Arm Description

Children in this condition will learn new words whose sounds are more like the sounds in the words the child already understands.

Children in this condition will learn new words whose sounds are less like the sounds in the words the child already understands.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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

Full Information

First Posted
June 14, 2023
Last Updated
June 26, 2023
Sponsor
University of Arizona
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT05921188
Brief Title
The Effect of Prior Learning on Word Learning
Official Title
Identification of Treatment Parameters That Maximize Language Treatment Efficacy for Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Development Disorders
Keywords
Late Talkers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantCare Provider
Masking Description
The children in the study and their caregivers will not be told which treatment group their child is in.
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
More Familiar Sounds
Arm Type
Experimental
Arm Description
Children in this condition will learn new words whose sounds are more like the sounds in the words the child already understands.
Arm Title
Less Familiar Sounds
Arm Type
Active Comparator
Arm Description
Children in this condition will learn new words whose sounds are less like the sounds in the words the child already understands.
Intervention Type
Behavioral
Intervention Name(s)
VAULT Phase 4
Intervention Description
Children will receive an input-based word learning treatment that is designed based on principles of statistical learning.
Primary Outcome Measure Information:
Title
Treatment Effect Size
Description
The investigators will count the number of spontaneous and probed productions of target and control words and calculate a treatment effect size (d).
Time Frame
Change from baseline through treatment, which will average an 8-week time frame.
Title
Number/Rate of Words Learned
Description
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.
Time Frame
Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
Secondary Outcome Measure Information:
Title
Post Treatment Retention
Description
The investigators will use probe data and parental report to determine how many of the words the child retained from treatment.
Time Frame
Change from end of treatment to follow up, which will average 4-6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Alt, PhD
Phone
520-626-6180
Email
malt@arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nora Evans-Reitz, MS
Phone
520-626-6885
Email
nevansreitz@arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Alt, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nora Evans-Reitz, MS
Phone
520-626-6885
Email
nevansreitz@arizona.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Prior Learning on Word Learning

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