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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05929859
Other study ID # 22-426
Secondary ID 1R01DC020959-01
Status Recruiting
Phase N/A
First received
Last updated
Start date October 26, 2023
Est. completion date December 2027

Study information

Verified date November 2023
Source Syracuse University
Contact Jonathan Preston, PhD
Phone 315-443-1351
Email jopresto@syr.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 84
Est. completion date December 2027
Est. primary completion date November 2027
Accepts healthy volunteers No
Gender All
Age group 9 Years to 17 Years
Eligibility 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 /?/ 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 /?/ 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Speech Motor Chaining
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.

Locations

Country Name City State
United States Syracuse University Syracuse New York

Sponsors (4)

Lead Sponsor Collaborator
Syracuse University National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 (/?/ 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 Proportion of responders and non-responders in each group. 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.
Secondary 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. Before the initiation of treatment and again 10 weeks later.
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