NCT05066178

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
55mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
May 2024Nov 2030

First Submitted

Initial submission to the registry

September 16, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
2.6 years until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2030

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2030

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

September 16, 2021

Last Update Submit

March 25, 2026

Conditions

Keywords

childhood apraxia of speechautismmotor speech disorderspeech development

Outcome Measures

Primary Outcomes (2)

  • Attempts Correct

    Number or percent of target items that were produced correctly

    5 weeks

  • Phonemes Correct

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

    5 weeks

Secondary Outcomes (2)

  • Lip aperture movement variability

    5 weeks

  • Phoneme distinctiveness

    5 weeks

Study Arms (1)

CAS Treatment for MV ASD

EXPERIMENTAL

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

Behavioral: CAS Treatment for Minimally Verbal Children with Autism

Interventions

Treatment involves principles of motor learning embedded in a naturalistic developmental milieu

CAS Treatment for MV ASD

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH Institute of Health Professions

Boston, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

ApraxiasAutism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Psychomotor DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Karen V Chenausky, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Outcome assessor will be blinded to participant session
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Multiple-baseline single-case design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 16, 2021

First Posted

October 4, 2021

Study Start

May 1, 2024

Primary Completion (Estimated)

April 30, 2030

Study Completion (Estimated)

November 30, 2030

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations