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Manipulating Linguistic Complexity to Improve Child Language Treatment Outcomes

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ClinicalTrials.gov Identifier: NCT03977701
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Jessica Barlow, San Diego State University

Brief Summary:
Phonological disorder (PD) and specific language impairment (SLI) directly impact a child's ability to communicate and are among the most prevalent developmental disorders. The proposed experiments manipulate the complexity of treatment targets to identify the most efficacious treatment approaches for English- and Spanish-speaking children aged 3 to 6 years who present with these disorders. This research will reveal the nature of interactions between sound and structure in language for these children and will have significant implications for a unique approach to target selection when treating persistent phonological and grammatical difficulties in children with PD, SLI, or both.

Condition or disease Intervention/treatment Phase
Language Development Disorders Speech Sound Disorder Behavioral: Phonological treatment Behavioral: Morpheme treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Manipulating Linguistic Complexity to Improve Child Language Treatment Outcomes
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : May 2023

Arm Intervention/treatment
Experimental: Mono-morphemic Singleton PD
Speech sound treatment on mono-morphemic singleton consonants for children with PD.
Behavioral: Phonological treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of speech sound targets following the methodology of Gierut and colleagues. Up to 100 productions will be targeted per 1-hour session.

Experimental: Mono-morphemic Singleton PD-SLI
Speech sound treatment on mono-morphemic singleton consonants for children with PD-SLI.
Behavioral: Phonological treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of speech sound targets following the methodology of Gierut and colleagues. Up to 100 productions will be targeted per 1-hour session.

Experimental: Mono-morphemic Cluster PD
Speech sound treatment on mono-morphemic consonant clusters for children with PD.
Behavioral: Phonological treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of speech sound targets following the methodology of Gierut and colleagues. Up to 100 productions will be targeted per 1-hour session.

Experimental: Mono-morphemic Cluster PD-SLI
Speech sound treatment on mono-morphemic consonant clusters for children with PD-SLI.
Behavioral: Phonological treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of speech sound targets following the methodology of Gierut and colleagues. Up to 100 productions will be targeted per 1-hour session.

Experimental: Bi-morphemic Singleton PD
Treatment on singletons in bi-morphemic contexts for children with PD.
Behavioral: Phonological treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of speech sound targets following the methodology of Gierut and colleagues. Up to 100 productions will be targeted per 1-hour session.

Experimental: Bi-morphemic Singleton PD-SLI
Treatment on singletons in bi-morphemic contexts for children with PD-SLI.
Behavioral: Phonological treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of speech sound targets following the methodology of Gierut and colleagues. Up to 100 productions will be targeted per 1-hour session.

Behavioral: Morpheme treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of targeted morphemes following the methodology of Plante and colleagues. A minimum of 50 productions will be targeted per 1-hour session.

Experimental: Bi-morphemic Cluster PD
Treatment on bi-morphemic consonant clusters for children with PD.
Behavioral: Phonological treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of speech sound targets following the methodology of Gierut and colleagues. Up to 100 productions will be targeted per 1-hour session.

Experimental: Bi-morphemic Cluster PD-SLI
Treatment on bi-morphemic consonant clusters for children with PD-SLI.
Behavioral: Phonological treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of speech sound targets following the methodology of Gierut and colleagues. Up to 100 productions will be targeted per 1-hour session.

Behavioral: Morpheme treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of targeted morphemes following the methodology of Plante and colleagues. A minimum of 50 productions will be targeted per 1-hour session.

Experimental: Bi-morphemic Singleton SLI
Treatment on singletons in bi-morphemic contexts for children with SLI.
Behavioral: Phonological treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of speech sound targets following the methodology of Gierut and colleagues. Up to 100 productions will be targeted per 1-hour session.

Behavioral: Morpheme treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of targeted morphemes following the methodology of Plante and colleagues. A minimum of 50 productions will be targeted per 1-hour session.

Experimental: Bi-morphemic Cluster SLI
Treatment on bi-morphemic consonant clusters for children with SLI.
Behavioral: Phonological treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of speech sound targets following the methodology of Gierut and colleagues. Up to 100 productions will be targeted per 1-hour session.

Behavioral: Morpheme treatment
The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of targeted morphemes following the methodology of Plante and colleagues. A minimum of 50 productions will be targeted per 1-hour session.




Primary Outcome Measures :
  1. Treatment Probe Accuracy Change [ Time Frame: Change from first treatment session to final treatment session; up to 6 weeks. ]
    The Treatment Probe is made of the selected treatment stimuli (words) that are consistent with the child's assigned experimental condition, and evaluates production accuracy of the stimuli. These words have a consonant singleton or consonant cluster ("tee" vs. "tree", "sees" vs. "seats"), and are mono- or bi-morphemic contexts ("tease" vs. "sees"). Children will be asked to pronounce each word following presentation of a corresponding picture and a verbal prompt. The Treatment Probe allows us to track the effectiveness of treatment on the treated stimuli.

  2. Generalization Probe Accuracy Change [ Time Frame: Change from baseline to immediately following final treatment session; up to 6 weeks. ]
    The Generalization Probe consists of words and phrases that target each consonant, cluster, and morpho-syntactic constructs a minimum of 10 times across relevant contexts (i.e., word- and utterance-position). The Generalization Probe allows us to track the effects of treatment (generalization) to untreated stimuli and to monitor control variables by measuring production accuracy of stimuli.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Participants will be recruited through announcements to schools and community organizations. Data will include caregiver-reported demographic data, scores on the standardized tests, digital recordings of subjects' spontaneous language, treatment probes and generalization probes, computerized analyses of speech/language samples and probes, and transcribed responses from speech/language samples and probes. All such data will be collected following caregiver consent and child assent. Further, all data will be collected at the SDSU clinic, with the exception of the caregiver report, which may be completed by the caregiver at home.

Screening procedures will include administration of the following:

  • Caregiver report of child history and language background, binaural hearing screening,
  • Goldman-Fristoe Test of Articulation 3 (GFTA3; English) or Bilingual English-Spanish Assessment (BESA; Spanish),
  • Preschool Language Scales (PLS; English or Spanish),
  • Leiter-R, spontaneous language sample, and
  • Protocol for the Assessment of English Phonotactics (PEEP; English) or Assessment of Spanish Phonology (ASP; Spanish).

Children who meet the inclusionary criteria below will be classified as having PD, SLI, or PD-SLI, per those criteria.

INCLUSIONARY CRITERIA:

All participating children must meet the following inclusionary criteria:

  • between the ages of 3 and 6 years of age;
  • speak Spanish (Experiment 1) or English (Experiments 2 and 3);
  • present with phonological disorder (PD, n = 22), specific language impairment (SLI, n = 6), or co-occurring PD-SLI (n = 18) (see below for additional criteria for inclusion).

The research program will over-recruit at 60 children, to reach the desired 46 participants. Participants will complete a battery of assessment measures. Information gleaned from these measures will be used to further determine eligibility for the proposed study, which include both quantitative and qualitative criteria. Specifically, all PD (Experiments 1 and 2) and PD-SLI (Experiment 2 and 3) participants must:

  • exhibit 5 or more sounds in error across three or more speech sound manner classes;
  • score ≤ 1.5 standard deviations below the mean on the GFTA3, if English-speaking;
  • score ≤ 1.5 standard deviations below the mean on the Phonology subtest of the BESA, if Spanish-speaking; and
  • exhibit ≤ 20% accuracy on consonants and clusters independent of tense morphemes.

Moreover, all SLI (Experiment 3) and PD-SLI (Experiments 2 and 3) participants must:

  • score ≤ 1 standard deviation below the mean on the Preschool Language Scales (PLS), a test of expressive and receptive language; and
  • exhibit a mean length of utterance (MLU) ≤ 1 standard deviation below the mean for age- and demographic-matched peers, based on a language sample.

EXCLUSIONARY CRITERIA:

All participants (Experiments 1, 2, and 3) must:

  • not be receiving speech/language services elsewhere;
  • pass a binaural hearing screening at 20 decibels;
  • achieve score above a standard score of 70 on a test of nonverbal cognition (Leiter-R); and
  • have typical intellectual, hearing, social-emotional, and neurological development, per parent report.

In addition, to rule out concomitant difficulty in other domains of language all PD participants (Experiments 1 and 2) must:

  • score > 1 standard deviation below the mean on the PLS, if English-speaking;
  • have an MLU > 1 standard deviation below the mean for age- and demographic-matched peers, based on a language sample.

To rule out concomitant difficulty in phonology, the SLI participants (Experiment 3) must:

  • score > 1.5 standard deviations below the mean on the GFTA3; and
  • exhibit fewer than 5 sounds in error and > 20% accuracy on final consonants and clusters independent of tense morphemes.

If the above criteria are not met, a child will be excluded from participation.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977701


Contacts
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Contact: Principal Investigator 619-594-0243 jbarlow@sdsu.edu

Locations
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United States, California
San Diego State University Speech-Language Clinic Recruiting
San Diego, California, United States, 92182
Contact: Jessica A Barlow, PhD    619-594-0243    jbarlow@sdsu.edu   
Sponsors and Collaborators
San Diego State University
National Institute on Deafness and Other Communication Disorders (NIDCD)
  Study Documents (Full-Text)

Documents provided by Jessica Barlow, San Diego State University:

Publications:

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Responsible Party: Jessica Barlow, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT03977701     History of Changes
Other Study ID Numbers: HS-2019-0021
R21DC017201 ( U.S. NIH Grant/Contract )
F31DC017697 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica Barlow, San Diego State University:
PHONOLOGY
MORPHOLOGY
Additional relevant MeSH terms:
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Language Development Disorders
Disease
Speech Sound Disorder
Pathologic Processes
Communication Disorders
Neurodevelopmental Disorders
Mental Disorders
Language Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms