Treating Childhood Apraxia of Speech

May 30, 2023 updated by: Jonathan Preston, Syracuse University

Treating Childhood Apraxia of Speech: Role of Biofeedback & Practice Distribution

The study will test two modifications to speech therapy for 40 school-age children with childhood apraxia of speech to determine how to improve treatment outcomes. The study will compare treatment that includes real-time visual feedback of the tongue during speech using ultrasound vs traditional therapy that does not include ultrasound visual feedback. Additionally, some children will be treated with a traditional schedule of 2 sessions per week, whereas others will be provided with treatment that begins with intensive training (10 hours of therapy in one week) and progresses to a more distributed treatment schedule.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Childhood apraxia of speech is a developmental speech sound disorder that may lead to persisting speech errors, often despite years of treatment. Such impairments may lead to social, academic, and vocational limitations. Thus, there is a need to explore alternate treatment approaches. This study will explore how to improve speech sound production in school-age children with CAS by modifying a standard speech therapy program. Two adaptations to speech therapy will be tested in a 2 x 2 randomized group design.

In Aim 1, a standard treatment schedule of 2 one-hour sessions per week will be compared against a treatment sequence beginning with an intensive therapy schedule (10 hrs of treatment in one week), which will then transition to a more distributed practice schedule. This treatment modification is intended to minimize erred practice between training sessions in the early stages of learning, then foster generalization through increased time between practice sessions.

In Aim 2, a standard treatment that includes only verbal feedback to the client during speech practice will be compared against a treatment sequence that initially includes real-time ultrasound visual feedback of the tongue during speech, which will be faded over the course of treatment. Ultrasound visual feedback is designed to train articulatory movements. It may enhance children's understanding of the articulatory goals of speech movement patterns by comparing executed tongue movements with intended movements. Prior case reports and single subject experimental designs have shown that speech sound production may be enhanced by including ultrasound visual feedback, although no prior randomized group studies have been conducted.

Beside these modifications, the other aspects of treatment will be held constant. Outcomes will be evaluated by tracking changes in percent consonants correct from a large speech sample, scored by individuals who are blind to treatment status. The four groups will be compared to determine the extent to which speech sound therapy can be enhanced through a treatment sequence that begins with intensive practice and/or with ultrasound visual feedback.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13244
        • Syracuse University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Native English speakers who hear English as the dominant language in their home setting.
  • Must pass a hearing screening.
  • Score at or better than -2 standard deviations from the mean on the Matrix Reasoning Task of the Wechsler Abbreviated Scale of Intelligence - 2nd Edition (WASI-2; t-score ≥ 30), Peabody Picture Vocabulary Test - 4th Edition (PPVT-4; standard score ≥ 70), and the Following Directions subtest of the Clinical Evaluation of Language Fundamentals - 5th Edition (CELF-5; scaled score ≥ 3).
  • Goldman-Fristoe Test of Articulation - 3rd Edition (GFTA-3) percentile ≤ 5th).
  • A diagnosis of CAS will be verified based on a polysyllable picture naming task, diadochokinetic task (puh-tuh-kuh), and syllable repetition task.

Exclusion Criteria:

  • Parent report or direct evaluation reveals oral-facial structural abnormalities (e.g., cleft palate).
  • Parental report of neurobehavioral disorders (e.g., autism spectrum disorders, ADHD, obsessive-compulsive disorder), or vision problems that are corrected with glasses/contacts.
  • Fail a hearing screening, or failure to meet criteria listed above as Inclusionary

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Biofeedback, Massed->Distributed
Sequenced biofeedback Mass Practice--> Distributed Scheduling
Behavioral: Biofeedback
Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.
Behavioral: Massed --> Distributed Practice
Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment
Active Comparator: No Biofeedback, Distributed
Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks
Behavioral: Speech Motor Chaining without Biofeedback
These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html
Behavioral: Distributed Practice
2 sessions per week for 10 weeks
Experimental: Biofeedback, Distributed
Sequenced biofeedback, 2 sessions/wk for 10 weeks
Behavioral: Biofeedback
Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.
Behavioral: Distributed Practice
2 sessions per week for 10 weeks
Experimental: No Biofeedback, Massed-> Distributed
Speech Motor Chaining with no biofeedback. Mass Practice--> Distributed Scheduling
Behavioral: Massed --> Distributed Practice
Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment
Behavioral: Speech Motor Chaining without Biofeedback
These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Speech Sound Accuracy
Time Frame: 10 weeks from the start of treatment
Percent consonants correct for target sounds: The primary outcome measure was percent correct for each participant's target sound-positions in untreated phrase. Participants imitated 20 pre-recorded phrases, each containing the target sound pattern 2 times per stimulus (e.g., for /l/ onset, "leave the location"), resulting in 40 attempts at each sound-position. For each session, 3 transcribers independently transcribed in Phon software (Hedlund & Rose, 2022) and accuracy was averaged across transcribers. Instances where IPA symbols for the Actual transcription differed from the Target transcription was scored as incorrect.
10 weeks from the start of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Speech sound accuracy
Time Frame: After 15 weeks from the start of treatment
Percent consonants correct
After 15 weeks from the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Syracuse University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Deafness and Other Communication Disorders (NIDCD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-177
  • R15DC016426 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Childhood Apraxia of Speech

Clinical Trials on Biofeedback

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings