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Intensive Speech Motor Chaining Treatment for Residual Speech Sound Disorders (iChain)

Primary Purpose

Speech Sound Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speech Motor Chaining
Sponsored by
Syracuse University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Speech Sound Disorder

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must speak American English as a dominant language. Must have began learning English by at least the age of 3 years. Must be between 9;0 to 17;11 years of age. Must have reported difficulty with /ɹ/ and/or /s/ production Must pass pure tone hearing screening at 25 dB at 1000, 2000, and 4000 Hz. Must receive a Standard score of 80 or above on the Receptive Language Index of the Clinical Evaluation of Language Fundamentals-5 (CELF-5). Must receive a percentile score of 5 or below on the Goldman-Fristoe Test of Articulation-3 (GFTA-3) Sounds in Words subtest. Must score <40% accurate on /ɹ/ and/or /s/ probes assessing these sounds at the word level. Must express a desire to modify their speech. Exclusion Criteria: Must have no known history of autism spectrum disorder, Down Syndrome, cerebral palsy, intellectual disability, permanent hearing loss, or brain injury. Must not have current cleft palate or voice disorder. Must not score within the "likely apraxic" or "likely dysarthric" range on Maximum Performance Task. Sub-study 2: Must have no known history of autism spectrum disorder, Down Syndrome, cerebral palsy, intellectual disability, permanent hearing loss, epilepsy/antiepileptic medication, or brain injury/neurosurgery/stroke. Must not have diagnosis of ADHD, ADD, Tourette's, or OCD. Must have no orthodontic appliances that block the roof of the mouth (e.g., palate expanders). Must not have current cleft palate, fluency disorder, or voice disorder. Must not score within the "likely apraxic" or "likely dysarthric" range on Maximum Performance Task.

Sites / Locations

  • Syracuse University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intensive Treatment

Distributed Treatment

Arm Description

Speech Motor Chaining will be delivered in an intensive fashion. Week 1: 8 sessions (2 sessions per day on 4 different days) Week 2: 3 sessions (1 per day on 3 different days) Week 3: 3 sessions (1 per day on 3 different days) Week 4: 2 sessions (1 per day on 2 different days)

Speech Motor Chaining will be delivered twice weekly for 8 weeks

Outcomes

Primary Outcome Measures

Change in percent correct for treated sound, rated by blinded listeners.
To assess generalization of treatment gains to untreated words, participants will read a 200-word probe list eliciting the treated sound (/ɹ/ or /s/). Stimuli in each probe will be presented individually in randomized order. No auditory models will be provided; for children with reading difficulty, semantic cues will be provided to elicit the intended word. Individual words will be isolated from the audio record of each word probe and presented in randomized order for binary rating (correct/incorrect) by listeners who are blind to treatment condition and time point (but will see the written representation of each target word). We will use the change in percent correct as our primary measure of perceptually rated accuracy.

Secondary Outcome Measures

Proportion of responders and non-responders in each group.
Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being.
This survey asks parents and participants to report the impact of speech disorder on their child's/their social, emotional, and academic well-being. Parents and participants are asked to select a number from 1 to 5 (1 = Strongly disagree, 3 = Neutral, 5 = Strongly agree). For all questions, a higher score indicates a greater degree of negative impact of speech disorder on social, emotional, or academic well-being.

Full Information

First Posted
June 20, 2023
Last Updated
June 20, 2023
Sponsor
Syracuse University
Collaborators
National Institutes of Health (NIH), State University of New York - Upstate Medical University, National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT05929859
Brief Title
Intensive Speech Motor Chaining Treatment for Residual Speech Sound Disorders
Acronym
iChain
Official Title
Intensive Speech Motor Chaining Treatment for Residual Speech Sound Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
November 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Syracuse University
Collaborators
National Institutes of Health (NIH), State University of New York - Upstate Medical University, National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this randomized-controlled trial is to compare distributed treatment schedules and intensive treatment schedules in 84 school-age children with residual speech sound disorders. The main question it aims to answer is: How does intensive and distributed treatment affect speech sound learning in residual speech sound disorder? Some participants will be treated with a traditional Distributed schedule of 2 sessions per weeks for 8 weeks (16 hours total), whereas others will be treated with an Intensive schedule and will complete 16 hours of treatment in 4 weeks.
Detailed Description
Residual speech sound disorders are defined as speech sound disorders that persist past ~8-9 years and may lead to social, academic, and vocational limitations. Thus, there is a need to investigate how treatment schedules affect speech sound learning. The overall objective of this study is to optimize a suite of theoretically motivated, high-fidelity, motor-based treatments delivered at the appropriate intensity, despite practical barriers, for the most commonly impacted RSSD sounds: /ɹ, s/. Our central working hypothesis, supported by our preliminary work, is that Speech Motor Chaining is more efficacious when delivered intensively (i.e., closely spaced for a fixed number of sessions). The theoretical rationale is that increasing intensity early in treatment will mitigate erred practice between sessions, improving outcomes relative to more customary practice distributions. To test this hypothesis, children will be randomly assigned to receive a standard Distributed treatment schedule or an Intensive treatment schedule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Sound Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized across two conditions, Distributed and Intensive (1:1 ratio). All participants will complete a Dynamic Assessment (DA) session consisting of 40-minutes of instruction and feedback on how to produce the /ɹ/ or /s/ sound. Following the DA session, participants will imitate 45 syllables containing the /ɹ/ or /s/ sound, and based on their performance, will be classified as High Stimulability or Low Stimulability. Participants will be stratified randomized to receive 16, 50-minute speech sessions in Intensive Treatment or Distributed Treatment.
Masking
Outcomes Assessor
Masking Description
All perceptual ratings will be obtained from raters who are blinded to treatment group and to timepoint. Binary rating responses will be obtained from three listeners per token.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive Treatment
Arm Type
Experimental
Arm Description
Speech Motor Chaining will be delivered in an intensive fashion. Week 1: 8 sessions (2 sessions per day on 4 different days) Week 2: 3 sessions (1 per day on 3 different days) Week 3: 3 sessions (1 per day on 3 different days) Week 4: 2 sessions (1 per day on 2 different days)
Arm Title
Distributed Treatment
Arm Type
Experimental
Arm Description
Speech Motor Chaining will be delivered twice weekly for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Speech Motor Chaining
Intervention Description
Sessions begin with Pre-practice to elicit target sounds, with verbal cueing and shaping strategies. During Structured Practice, items are practice in blocks of 6 consecutive trials (with systematic increases in difficulty), and our web-based software will manipulate the principles of motor learning, including the stimulus prompt, the participant's production, analysis of the clinician's rating, feedback prompts for the clinician, and the variability present in the practice trial. Randomized Practice will also be guided by the software and includes all linguistic levels that were produced correctly during Structured Practice, with items presented in random order.
Primary Outcome Measure Information:
Title
Change in percent correct for treated sound, rated by blinded listeners.
Description
To assess generalization of treatment gains to untreated words, participants will read a 200-word probe list eliciting the treated sound (/ɹ/ or /s/). Stimuli in each probe will be presented individually in randomized order. No auditory models will be provided; for children with reading difficulty, semantic cues will be provided to elicit the intended word. Individual words will be isolated from the audio record of each word probe and presented in randomized order for binary rating (correct/incorrect) by listeners who are blind to treatment condition and time point (but will see the written representation of each target word). We will use the change in percent correct as our primary measure of perceptually rated accuracy.
Time Frame
Before the initiation of treatment and again 10 weeks later.
Secondary Outcome Measure Information:
Title
Proportion of responders and non-responders in each group.
Time Frame
10 weeks after the start of treatment.
Title
Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being.
Description
This survey asks parents and participants to report the impact of speech disorder on their child's/their social, emotional, and academic well-being. Parents and participants are asked to select a number from 1 to 5 (1 = Strongly disagree, 3 = Neutral, 5 = Strongly agree). For all questions, a higher score indicates a greater degree of negative impact of speech disorder on social, emotional, or academic well-being.
Time Frame
Before the initiation of treatment and again 10 weeks later.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must speak American English as a dominant language. Must have began learning English by at least the age of 3 years. Must be between 9;0 to 17;11 years of age. Must have reported difficulty with /ɹ/ and/or /s/ production Must pass pure tone hearing screening at 25 dB at 1000, 2000, and 4000 Hz. Must receive a Standard score of 80 or above on the Receptive Language Index of the Clinical Evaluation of Language Fundamentals-5 (CELF-5). Must receive a percentile score of 5 or below on the Goldman-Fristoe Test of Articulation-3 (GFTA-3) Sounds in Words subtest. Must score <40% accurate on /ɹ/ and/or /s/ probes assessing these sounds at the word level. Must express a desire to modify their speech. Exclusion Criteria: Must have no known history of autism spectrum disorder, Down Syndrome, cerebral palsy, intellectual disability, permanent hearing loss, or brain injury. Must not have current cleft palate or voice disorder. Must not score within the "likely apraxic" or "likely dysarthric" range on Maximum Performance Task. Sub-study 2: Must have no known history of autism spectrum disorder, Down Syndrome, cerebral palsy, intellectual disability, permanent hearing loss, epilepsy/antiepileptic medication, or brain injury/neurosurgery/stroke. Must not have diagnosis of ADHD, ADD, Tourette's, or OCD. Must have no orthodontic appliances that block the roof of the mouth (e.g., palate expanders). Must not have current cleft palate, fluency disorder, or voice disorder. Must not score within the "likely apraxic" or "likely dysarthric" range on Maximum Performance Task.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Preston, PhD
Phone
315-443-1351
Email
jopresto@syr.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Benway, PhD
Email
nrbenway@syr.edu
Facility Information:
Facility Name
Syracuse University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13244
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Preston, PhD
Phone
315-443-3143
Email
jopresto@syr.edu
First Name & Middle Initial & Last Name & Degree
Nicole Caballero, MS
Phone
315-443-1185
Email
nfcaball@syr.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
31051085
Citation
Preston JL, Leece MC, Storto J. Tutorial: Speech Motor Chaining Treatment for School-Age Children With Speech Sound Disorders. Lang Speech Hear Serv Sch. 2019 Jul 12;50(3):343-355. doi: 10.1044/2018_LSHSS-18-0081. Epub 2019 May 3.
Results Reference
background
Links:
URL
https://speechproductionlab.syr.edu/research/
Description
Lab website with recruitment information

Learn more about this trial

Intensive Speech Motor Chaining Treatment for Residual Speech Sound Disorders

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