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Addressing Treatment Nonresponders

Primary Purpose

Language Development Disorders

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
VAULT Phase 6
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 at start of study MacArthur-Bates Communicative Development Inventories (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

    Alternative Treatment Including Augmentative and Alternative Communication

    Usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment

    Arm Description

    Once children are shown to not respond to the usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment, they will be placed in this arm, which will train them to use an Augmentative and Alternative Communication device as an additional means to use to 'say' a word.

    Children who do appear to respond to treatment will continue with the full course of usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) intervention.

    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 the treatment.

    Secondary Outcome Measures

    Post Treatment Retention
    We will use probe data or specific words 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
    NCT05921227
    Brief Title
    Addressing Treatment Nonresponders
    Official Title
    Identification of Treatment Parameters the 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 2025 (Anticipated)
    Primary Completion Date
    June 2027 (Anticipated)
    Study Completion Date
    August 2027 (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 see if providing late talking toddlers who are not responding to the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment with a different way of communicating will help them improve their word learning. Participants will start with VAULT word learning treatment. If, in the first few sessions, it looks like they won't respond well, they will be provided with a Big Mack Augmentative and Alternative Communication device (a button that says a word when you press it) to use for their responses. The investigators will see if this modification will help with word learning.
    Detailed Description
    Children will begin Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment. If, after three sessions, they do not show an initial response to treatment, they will be provided with a Big Mack Augmentative and Alternative Communication device which will allow them to 'say' the treatment words with the device. Treatment will continue until the children have had 8 total weeks of treatment (2x/wk for 30 minutes per session). The investigators will measure word learning across time tracking both spoken productions and productions made with the device.

    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
    Sequential Assignment
    Model Description
    All participants will start in the traditional Vocabulary Acquisition and Usage for Late Talkers (VAULT) model. Those who do not respond to treatment early on will be moved to the Augmentative and Alternative Communication Device arm of the treatment.
    Masking
    ParticipantCare Provider
    Masking Description
    The children and their caregivers will not be told which condition they are assigned to. However, the Augmentative and Alternative Communication device is quite obvious, so although caregivers will not be explicitly told, it is likely they will be aware their child is in that arm.
    Allocation
    Non-Randomized
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Alternative Treatment Including Augmentative and Alternative Communication
    Arm Type
    Experimental
    Arm Description
    Once children are shown to not respond to the usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment, they will be placed in this arm, which will train them to use an Augmentative and Alternative Communication device as an additional means to use to 'say' a word.
    Arm Title
    Usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment
    Arm Type
    Active Comparator
    Arm Description
    Children who do appear to respond to treatment will continue with the full course of usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    VAULT Phase 6
    Intervention Description
    VAULT is an input-based word learning intervention 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 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
    We will use probe data or specific words 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 at start of study MacArthur-Bates Communicative Development Inventories (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, m
    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

    Addressing Treatment Nonresponders

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