- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05066178
Speech Treatment for Minimally Verbal Children With ASD and CAS (TxMVASD+CAS)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karen V Chenausky, Ph.D.
- Phone Number: 617-726-2405
- Email: kvchenausky@mghihp.edu
Study Contact Backup
- Name: Michael Moody
- Phone Number: 617-643-4658
- Email: mjmoody@partners.org
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02129
- Recruiting
- MGH Institute of Health Professions
-
Contact:
- Steve Meyer
- Phone Number: 617-726-2405
- Email: ihpspanlab@mghb.org
-
Contact:
- Karen Chenausky, PhD
- Email: kvchenausky@mghihp.edu
-
Principal Investigator:
- Karen V Chenausky, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meets criteria for Autism Spectrum Disorder
- Able to correctly repeat at least 2 syllables
- Meets criteria for Childhood Apraxia of Speech
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CAS Treatment for MV ASD
Participants will receive CAS treatment, modified for minimally verbal children with autism
|
Treatment involves principles of motor learning embedded in a naturalistic developmental milieu
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attempts Correct
Time Frame: 5 weeks
|
Number or percent of target items that were produced correctly
|
5 weeks
|
Phonemes Correct
Time Frame: 5 weeks
|
Number or percent of phonemes (vowels, consonants) in the target items that were produced correctly
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lip aperture movement variability
Time Frame: 5 weeks
|
Amount of variability in lip opening area during production of multiple attempts at the same target
|
5 weeks
|
Phoneme distinctiveness
Time Frame: 5 weeks
|
Acoustic distinctiveness of different phonemes
|
5 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021P002598
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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