Intensive Speech Motor Chaining Treatment for Residual Speech Sound Disorders (iChain)

November 20, 2023 updated by: Syracuse University

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

Recruiting

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jonathan Preston, PhD
  • Phone Number: 315-443-1351
  • Email: jopresto@syr.edu

Study Contact Backup

Study Locations

    • New York
      • Syracuse, New York, United States, 13244
        • Recruiting
        • Syracuse University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

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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