Speech Sound DisorderPhase 1/2iChainNCT05929859
Intensive Speech Motor Chaining Treatment for Residual Speech Sound Disorders
A Phase 1/2 study testing Speech Motor Chaining in people with Speech Sound Disorder, run by Syracuse University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Speech Sound Disorder
- What is being tested?
- Speech Motor Chaining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2023to 29 Feb 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nina Benway, PhD contact
United States1 site, 1 recruiting
- Recruiting
Syracuse University
Syracuse, New York, 13244
Jonathan Preston, PhD, 315-443-3143, jopresto@syr.edu
Nicole Caballero, MS, 315-443-1185, nfcaball@syr.edu
About this study
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.
Read the 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.
- Conditions
- Speech Sound Disorder
- Being tested
- Speech Motor Chaining
- Medical subject headings
- Speech Sound Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech Motor ChainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Treatment | Experimental | 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) Receives: Behavioral: Speech Motor Chaining |
| Distributed Treatment | Experimental | Speech Motor Chaining will be delivered twice weekly for 8 weeks Receives: Behavioral: Speech Motor Chaining |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the initiation of treatment and again 10 weeks later.
Secondary outcomes (2)
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.
Measured: 10 weeks after the start of treatment.
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.
Measured: Before the initiation of treatment and again 10 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start26 Oct 2023
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Speech Sound DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), State University of New York - Upstate Medical University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Jonathan Preston, PhD, Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929859
- Sponsor's protocol ID
- 22-426
- Other IDs
- 1R01DC020959-01
- Acronym
- iChain
- Status last verified
- Jan 2026
- First submitted
- 20 Jun 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31051085
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Speech Motor Chaining Treatment for Residual Speech Sound Disorders
- ClinicalTrials.gov ID
- NCT05929859
- Acronym / sponsor ID
- iChain / 22-426
- Conditions
- Speech Sound Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), State University of New York - Upstate Medical University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intensive Treatment | Experimental | Behavioral: Speech Motor ChainingSpeech 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) |
| Distributed Treatment | Experimental | Behavioral: Speech Motor ChainingSpeech Motor Chaining will be delivered twice weekly for 8 weeks |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech Motor ChainingSessions 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. | Behavioural | Distributed Treatment, Intensive Treatment |
Primary outcome
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.
2 secondary outcomes
Proportion of responders and non-responders in each group.
Time frame: 10 weeks after the start of treatment.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 31051085Preston 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.
- Lab website with recruitment informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nina Benway, PhD contact
Jonathan Preston, PhD principal investigator
Syracuse University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Speech Motor Chaining in people with Speech Sound Disorder, run by Syracuse University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Preston, PhD (315-443-1351, jopresto@syr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent correct for treated sound, rated by blinded listeners. (time frame: Before the initiation of treatment and again 10 weeks later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.