NCT03623100

Brief Summary

Children with speech sound disorders (SSD) are thought to be unable to detect subtle differences between sounds, though there is little understanding of the underlying perceptual mechanisms implicated in SSD. The investigators suggest that children with SSD may have difficulty creating phonological representations due to inaccurate perception and representation of speech sounds, which then directly impacts speech production abilities. Children will be randomly assigned to one of two treatment conditions in the present study: 1) Traditional speech treatment alone or 2) Traditional speech treatment in conjunction with speech perceptual training. By identifying an underlying mechanism of the disorder, the clinical approach to the treatment of SSD will be better informed and treatment approaches targeting all deficient areas can be utilized.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress98%
Aug 2014Jul 2026

Study Start

First participant enrolled

August 1, 2014

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

10 years

First QC Date

July 23, 2018

Last Update Submit

May 6, 2025

Conditions

Keywords

ChildrenPhonologyEEGERPABRFFR

Outcome Measures

Primary Outcomes (1)

  • Change from baseline treated sound production accuracy at four months

    Each treated sound will be point-by-point identified as being correct or incorrect in relation to its target phoneme. From these values, generalization data from each child will be examined from both descriptive and quantitative perspectives. Generalization will be descriptively defined using the learning criterion level of 10% or greater accuracy change in treated phonemes (Gierut \& Morrisette, 2012a). For each child and each condition, generalization will be examined to see if the 10% criterion is met. Quantitatively, the amount of change from pre- to post-intervention in treated phoneme accuracy will be calculated separately for each child.

    an average of 4 months

Secondary Outcomes (6)

  • Change from baseline Mismatch Negativity (MMN) mean amplitude at four months

    an average of 4 months

  • Change from baseline P1/P2 mean amplitude at four months

    an average of 4 months

  • Event-related spectral perturbation (ERSP) channel analyses

    an average of 4 months

  • Change from baseline frequency following responses (FFRs) at four months

    an average of 4 months

  • Event-related spectral perturbation (ERSP) independent component (IC) analyses

    an average of 4 months

  • +1 more secondary outcomes

Study Arms (2)

Speech Treatment

EXPERIMENTAL

Half of the children will be assigned to the traditional speech treatment program which will focus on how to produce sounds in academic vocabulary words.

Behavioral: Speech Production Treatment.

Speech Treatment & Perception

EXPERIMENTAL

Half of the children will be assigned to the traditional speech treatment program and speech perception training program combination. This treatment program will teach children not only how to produce sounds in academic vocabulary words, but to also identify correctly and incorrectly produced sounds in words.

Behavioral: Speech Production + Speech Perception Treatment.

Interventions

Speech production treatment will be delivered in two phases: Imitation and Spontaneous Production. Treatment will be provided two times weekly in 1-hour sessions, for up to 19 sessions. Every child's intervention program will target a single phoneme that was excluded from his or her phonemic inventory. Each treatment phoneme will be targeted through the production of five words that will be initially introduced to the child using a storybook reading format. Imitation treatment will continue until a child maintains 75% accurate production of the treated phoneme over two consecutive sessions (i.e. performance-based criterion) or until seven consecutive sessions are completed (i.e. time-based criterion). Spontaneous Production will continue until the child maintains either a performance-based criterion of 90% accurate production of the treated phoneme over 3 consecutive sessions, or a time-based criterion of 12 consecutive sessions.

Speech Treatment

This speech treatment condition will be administered in the same way as the Speech Production treatment. The difference in conditions will be that speech treatment in this condition will last for 50 minutes rather than 60 minutes. The remaining 10 minutes of each session will involve the speech perception training. These speech perception tasks will involve previously recorded word-level productions focusing on the same phoneme that is addressed in speech production treatment in word-initial position. A variety of words produced correctly and incorrectly by adults and children will be presented in pairs and the children will have to determine if the words contain the same word-initial phoneme or two different phonemes.

Speech Treatment & Perception

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Between the ages of 4;0 and 6;0 years
  • English monolingual speakers
  • Typical hearing abilities
  • Typical overall development
  • No apparent organic anomalies of the speech mechanism
  • No global cognitive delays
  • No receptive language impairments
  • Speech production abilities below the 10th percentile
  • Exclude a minimum of 4 English consonants from sound repertoire
  • No prior speech and/or language intervention services
  • Prior diagnosis of speech sound disorder (SSD)
  • \- All speech and language measures in the typical range

You may not qualify if:

  • Speaking a language other than (or in addition to) English
  • Being above the age of 6 years or under 4 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Idaho State University - Meridian

Meridian, Idaho, 83642-7991, United States

Location

MeSH Terms

Conditions

Speech Sound Disorder

Condition Hierarchy (Ancestors)

Communication DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Alycia E Cummings, Ph.D.

    Idaho State University - Meridian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A single-subject staggered multiple baseline design will be used in the speech treatment program. Following procedures for this design, the children with SSD will be randomly assigned to one of two treatment conditions. These groups will be evaluated independently and in combination. Every subject will be evaluated in a baseline period in which no treatment is provided. Every subject will first complete a full baseline assessment. Subsequent baselines will consist only of a shorter baseline probe that specifically targets the phonemes each child did not produce during the initial baseline session. Thus, the first subject in each condition will have 2 baselines and then begin treatment. Each subsequent subject within each condition will have 1 additional baseline before beginning treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 9, 2018

Study Start

August 1, 2014

Primary Completion

July 31, 2024

Study Completion (Estimated)

July 31, 2026

Last Updated

May 9, 2025

Record last verified: 2025-05

Locations