search
Back to results

Speech Treatment for Minimally Verbal Children With ASD and CAS (TxMVASD+CAS)

Primary Purpose

Developmental Verbal Dyspraxia, Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CAS Treatment for Minimally Verbal Children with Autism
Sponsored by
MGH Institute of Health Professions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Verbal Dyspraxia focused on measuring childhood apraxia of speech, autism, motor speech disorder, speech development

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meets criteria for Autism Spectrum Disorder
  • Able to correctly repeat at least 2 syllables
  • Meets criteria for Childhood Apraxia of Speech
  • Produces no more than 20 different words and no productive phrase speech during language sample
  • Lives in an environment where child is exposed to English at least 50% of the time

Exclusion Criteria:

  • Poorly controlled seizures
  • Factors such as blindness or deafness that contribute to minimally verbal status
  • Lives in an environment where English is not spoken at least 50% of the time
  • Child experiences behavioral challenges that preclude participation in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CAS Treatment for MV ASD

    Arm Description

    Participants will receive CAS treatment, modified for minimally verbal children with autism

    Outcomes

    Primary Outcome Measures

    Attempts Correct
    Number or percent of target items that were produced correctly
    Phonemes Correct
    Number or percent of phonemes (vowels, consonants) in the target items that were produced correctly

    Secondary Outcome Measures

    Lip aperture movement variability
    Amount of variability in lip opening area during production of multiple attempts at the same target
    Phoneme distinctiveness
    Acoustic distinctiveness of different phonemes

    Full Information

    First Posted
    September 16, 2021
    Last Updated
    September 22, 2021
    Sponsor
    MGH Institute of Health Professions
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05066178
    Brief Title
    Speech Treatment for Minimally Verbal Children With ASD and CAS
    Acronym
    TxMVASD+CAS
    Official Title
    Speech Treatment for Minimally Verbal Children With ASD and CAS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    November 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    MGH Institute of Health Professions

    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
    Comorbid Childhood Apraxia of Speech (CAS) may be one factor that limits speech development in some minimally verbal children with autism. CAS is a disorder affecting speech movement planning. This study tests whether CAS-specific treatment, appropriately modified for minimally verbal children with autism, improves their speech.
    Detailed Description
    Although one in four children with autism remain minimally verbal past age five, not all the factors that limit spoken language in these minimally verbal children are known. One powerful contributor may be a motor speech disorder, Childhood Apraxia of Speech (CAS). CAS is an impairment in the ability to plan and sequence for speech, which makes speech inconsistent and imprecise. This project proposes to investigate whether CAS makes the speech of minimally verbal children with autism unintelligible, and then to test whether treating the CAS improves children's speech. First, a cohort of 20 minimally verbal children with both autism and CAS is identified. The prediction is that the more severe the CAS, the more inconsistent and imprecise a child's speech, and therefore the lower their intelligibility will be. Then, a set of mono- and bisyllabic words is selected that contain the disordered movements that each child shows and use those in treatment. Treatment will take the form of 15 one-hour sessions where speech practice is embedded in a naturalistic, play-based milieu that is centered on each child's own developmental level. It will involve principles of motor learning (intensive practice of a few words, sometimes all in a row and sometimes mixed up). Different types of cues (touch cues, simultaneous production, etc.) will also be employed to help children say their words correctly, fading back these supports as the child's speech improves. Both of these techniques have been shown to be effective for treating CAS. Our outcome measures will include both (1) "by-ear" assessments of intelligibility and (2) acoustic and kinematic measurements of children's speech after 15 treatment sessions. The findings will inform clinical practice for minimally verbal children with autism and may lead to the development of novel interventions for this severely affected population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Developmental Verbal Dyspraxia, Autism Spectrum Disorder
    Keywords
    childhood apraxia of speech, autism, motor speech disorder, speech development

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Multiple-baseline single-case design
    Masking
    None (Open Label)
    Masking Description
    Outcome assessor will be blind to assessment date (pre-, mid-, or post-treatment).
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CAS Treatment for MV ASD
    Arm Type
    Experimental
    Arm Description
    Participants will receive CAS treatment, modified for minimally verbal children with autism
    Intervention Type
    Behavioral
    Intervention Name(s)
    CAS Treatment for Minimally Verbal Children with Autism
    Intervention Description
    Treatment involves principles of motor learning embedded in a naturalistic developmental milieu
    Primary Outcome Measure Information:
    Title
    Attempts Correct
    Description
    Number or percent of target items that were produced correctly
    Time Frame
    5 weeks
    Title
    Phonemes Correct
    Description
    Number or percent of phonemes (vowels, consonants) in the target items that were produced correctly
    Time Frame
    5 weeks
    Secondary Outcome Measure Information:
    Title
    Lip aperture movement variability
    Description
    Amount of variability in lip opening area during production of multiple attempts at the same target
    Time Frame
    5 weeks
    Title
    Phoneme distinctiveness
    Description
    Acoustic distinctiveness of different phonemes
    Time Frame
    5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meets criteria for Autism Spectrum Disorder Able to correctly repeat at least 2 syllables Meets criteria for Childhood Apraxia of Speech Produces no more than 20 different words and no productive phrase speech during language sample Lives in an environment where child is exposed to English at least 50% of the time Exclusion Criteria: Poorly controlled seizures Factors such as blindness or deafness that contribute to minimally verbal status Lives in an environment where English is not spoken at least 50% of the time Child experiences behavioral challenges that preclude participation in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karen V Chenausky, Ph.D.
    Phone
    617-726-2405
    Email
    kvchenausky@mghihp.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Speech Treatment for Minimally Verbal Children With ASD and CAS

    We'll reach out to this number within 24 hrs