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
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
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
NCT ID
NCT05066178
First Posted
September 16, 2021
Last Updated
September 22, 2021
Sponsor
MGH Institute of Health Professions
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
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