NCT03238677

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

May 1, 2023

Enrollment Period

4.8 years

First QC Date

August 1, 2017

Results QC Date

April 19, 2023

Last Update Submit

May 30, 2023

Conditions

Keywords

speech sound disorder

Outcome Measures

Primary Outcomes (1)

  • Speech Sound Accuracy

    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

Study Arms (4)

Biofeedback, Massed->Distributed

EXPERIMENTAL

Sequenced biofeedback Mass Practice--\> Distributed Scheduling

Behavioral: BiofeedbackBehavioral: Massed --> Distributed Practice

No Biofeedback, Distributed

ACTIVE COMPARATOR

Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks

Behavioral: Speech Motor Chaining without BiofeedbackBehavioral: Distributed Practice

Biofeedback, Distributed

EXPERIMENTAL

Sequenced biofeedback, 2 sessions/wk for 10 weeks

Behavioral: BiofeedbackBehavioral: Distributed Practice

No Biofeedback, Massed-> Distributed

EXPERIMENTAL

Speech Motor Chaining with no biofeedback. Mass Practice--\> Distributed Scheduling

Behavioral: Speech Motor Chaining without BiofeedbackBehavioral: Massed --> Distributed Practice

Interventions

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

No Biofeedback, DistributedNo Biofeedback, Massed-> Distributed
BiofeedbackBEHAVIORAL

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.

Biofeedback, DistributedBiofeedback, Massed->Distributed

2 sessions per week for 10 weeks

Biofeedback, DistributedNo Biofeedback, Distributed

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

Biofeedback, Massed->DistributedNo Biofeedback, Massed-> Distributed

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

Location

Related Publications (2)

  • Preston JL, Leece MC, Maas E. Intensive Treatment with Ultrasound Visual Feedback for Speech Sound Errors in Childhood Apraxia. Front Hum Neurosci. 2016 Aug 30;10:440. doi: 10.3389/fnhum.2016.00440. eCollection 2016.

    PMID: 27625603BACKGROUND
  • Preston JL, Leece MC, McNamara K, Maas E. Variable Practice to Enhance Speech Learning in Ultrasound Biofeedback Treatment for Childhood Apraxia of Speech: A Single Case Experimental Study. Am J Speech Lang Pathol. 2017 Aug 15;26(3):840-852. doi: 10.1044/2017_AJSLP-16-0155.

    PMID: 28715554BACKGROUND

Related Links

MeSH Terms

Conditions

ApraxiasSpeech Sound Disorder

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Psychomotor DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCommunication DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Limitations and Caveats

The interruptions due to the COVID-19 pandemic resulted an imbalance in participants in the Ultrasound vs No Ultrasound conditions, which limits statistical power. Participants were not randomized to telepractice vs face-to-face. Also, the treatment emphasizes speech sound accuracy. There is not a direct focus on teaching other features such as lexical stress. Other approaches, such as Rapid Syllable Transition Training would be more appropriate to address other elements of speech production.

Results Point of Contact

Title
Jonathan Preston
Organization
Syracuse University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Individuals who conduct the phonetic transcriptions that will be used for the primary outcome data will be blinded as to whether the recordings were collected before or after treatment, and also blinded as to the group assignment of the participant.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 2 x 2 design Scheduling: Mass--\>Distributed vs. Distributed only Visual feedback: Sequenced Ultrasound Biofeedback vs. No biofeedback
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 3, 2017

Study Start

August 1, 2017

Primary Completion

May 9, 2022

Study Completion

June 7, 2022

Last Updated

June 22, 2023

Results First Posted

June 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations