NCT05929859

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
21mo left

Started Oct 2023

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Oct 2023Feb 2028

First Submitted

Initial submission to the registry

June 20, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 26, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2028

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

4.3 years

First QC Date

June 20, 2023

Last Update Submit

January 12, 2026

Conditions

Speech Sound Disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before the initiation of treatment and again 10 weeks later.

Secondary Outcomes (2)

  • Proportion of responders and non-responders in each group.

    10 weeks after the start of treatment.

  • Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being.

    Before the initiation of treatment and again 10 weeks later.

Study Arms (2)

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)

Behavioral: Speech Motor Chaining

Distributed Treatment

EXPERIMENTAL

Speech Motor Chaining will be delivered twice weekly for 8 weeks

Behavioral: Speech Motor Chaining

Interventions

Speech Motor ChainingBEHAVIORAL

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.

Distributed TreatmentIntensive Treatment

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

RECRUITING

Related 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.

    PMID: 31051085BACKGROUND

Related Links

MeSH Terms

Conditions

Speech Sound Disorder

Condition Hierarchy (Ancestors)

Communication DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jonathan Preston, PhD

    Syracuse University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Preston, PhD

CONTACT

315-443-1351jopresto@syr.edu

Nina Benway, PhD

CONTACT

nrbenway@syr.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 3, 2023

Study Start

October 26, 2023

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

February 29, 2028

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

US(1)