- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05929859
Intensive Speech Motor Chaining Treatment for Residual Speech Sound Disorders (iChain)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonathan Preston, PhD
- Phone Number: 315-443-1351
- Email: jopresto@syr.edu
Study Contact Backup
- Name: Nina Benway, PhD
- Email: nrbenway@syr.edu
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13244
- Recruiting
- Syracuse University
-
Contact:
- Jonathan Preston, PhD
- Phone Number: 315-443-3143
- Email: jopresto@syr.edu
-
Contact:
- Nicole Caballero, MS
- Phone Number: 315-443-1185
- Email: nfcaball@syr.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 scaled score of at least 5 on the Listening Comprehension and Story Retelling subtests of the Test of Integrated Language and Literacy Skills (TILLS)
- Must receive a percentile score of 5 or below on the Goldman-Fristoe Test of Articulation-3 (GFTA-3) Sounds in Words subtest.
- Must have 1 scorable response with 5+ consecutive correct /pataka/ with > 3.4 syllables per second in the MRR-Tri task of the Maximum Performance Tasks OR must demonstrate no childhood apraxia of speech (CAS-only) features in BOTH articulatory and rate/prosody domains of the ProCAD.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intensive Treatment
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)
|
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.
|
Experimental: Distributed Treatment
Speech Motor Chaining will be delivered twice weekly for 8 weeks
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in percent correct for treated sound, rated by blinded listeners.
Time Frame: Before the initiation of treatment and again 10 weeks later.
|
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.
|
Before the initiation of treatment and again 10 weeks later.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being.
Time Frame: Before the initiation of treatment and again 10 weeks later.
|
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.
|
Before the initiation of treatment and again 10 weeks later.
|
Proportion of responders and non-responders in each group.
Time Frame: 10 weeks after the start of treatment.
|
A chi-square test will be used to analyze the proportion of responders and non-responders (i.e., those above/below 15% change on the probes) in each group.
|
10 weeks after the start of treatment.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan Preston, PhD, Syracuse University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-426
- 1R01DC020959-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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