Clinical trial NCT05929859: Intensive Speech Motor Chaining Treatment for Residual Speech Sound Disorders
Official title: Intensive Speech Motor Chaining Treatment for Residual Speech Sound Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Speech Sound Disorder
Lead sponsor: Syracuse University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: State University of New York - Upstate Medical University
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2023-07-03
Enrollment: 84
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Change in percent correct for treated sound, rated by blinded listeners.
timeFrame: Before the initiation of treatment and again 10 weeks later.
Secondary outcomes:
measure: Proportion of responders and non-responders in each group.
timeFrame: 10 weeks after the start of treatment.
measure: Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being.
timeFrame: Before the initiation of treatment and again 10 weeks later.
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
affiliation: Syracuse University
name: Jonathan Preston, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.