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The Effect of Semantic Support on Word Learning

Primary Purpose

Language Development Disorders

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
VAULT Phase 5
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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Familiar Words

    Less-Familiar Words

    Arm Description

    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.

    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.

    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 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

    Post Treatment Retention
    The investigators will use probe data and parental report to determine how many 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
    NCT05921214
    Brief Title
    The Effect of Semantic Support 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
    Not yet recruiting
    Study Start Date
    June 2024 (Anticipated)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    December 2026 (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 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.
    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.

    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
    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
    ParticipantCare Provider
    Masking Description
    The late talkers and their caregivers will not explicitly be told what condition their child is in.
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Familiar Words
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Less-Familiar Words
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    VAULT Phase 5
    Intervention Description
    This is an input-based vocabulary learning treatment 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 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.
    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 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 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
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of Semantic Support on Word Learning

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