NCT01905449

Brief Summary

Children with speech sound disorders will receive speech therapy using real-time images of the tongue from ultrasound. These images will be used to cue the child to change the tongue position when producing speech sounds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2013

Typical duration for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

3.2 years

First QC Date

July 16, 2013

Last Update Submit

April 1, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent correct for target speech sound

    Change in accuracy after 7 one-hour treatment sessions (3.5 weeks), and after 14 one-hour treatment sessions (7 weeks)

Study Arms (2)

Ultrasound plus prosodic cues

EXPERIMENTAL

One sound in error is treated with ultrasound visual feedback while also cueing prosodic variation (7 one-hour sessions). Another sound in error is treated with the ultrasound visual feedback with no prosodic variation (7 one-hour sessions). Prosodic variations are cues to coordinate production of the target sound with intonation patterns such as questions (rising intonations), commands (loud/emphatic), or statements (neutral)

Behavioral: Ultrasound visual feedback

Ultrasound vs Traditional treatment

EXPERIMENTAL

One sound in errors is treated with ultrasound visual feedback for approximately half of each session and traditional treatment for half of the session (7 one-hour sessions). Another sound in error is treated with no ultrasound visual feedback, using traditional treatment for the entire session (7 one-hour sessions). These traditional cues include verbal instructions on how to move the tongue to achieve a particular speech sound.

Behavioral: Ultrasound visual feedback

Interventions

Real-time visual displays of the tongue are used to cue participants to modify the tongue position/shape as they articulate speech sounds

Ultrasound plus prosodic cuesUltrasound vs Traditional treatment

Eligibility Criteria

Age8 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants must be native English-speaking children with no known hearing or vision deficits. Participants must be within the specified age range and have been identified as having speech production difficulties by a local speech-language therapist.

You may not qualify if:

  • Participants will be excluded if there is a history of oral structural impairment (e.g., cleft palate), hearing or vision impairment, history of neurological impairment or injury, developmental disabilities such as Down Syndrome or Autism, or intellectual disability.
  • During initial testing, participants must score below a standard score of 75 on the Goldman-Fristoe Test of Articulation-2 and also score below 20% accurate on a probe list of words assessing accuracy of the /r/ sound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haskins Laboratories

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Speech Sound Disorder

Condition Hierarchy (Ancestors)

Communication DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jonathan Preston, PhD

    Haskins Laboratories

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2013

First Posted

July 23, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 3, 2020

Record last verified: 2020-04

Locations