NCT03977701

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 9, 2023

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

May 31, 2019

Results QC Date

January 12, 2023

Last Update Submit

March 7, 2023

Conditions

Keywords

PHONOLOGYMORPHOLOGY

Outcome Measures

Primary Outcomes (2)

  • Treatment Probe Accuracy Change

    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 treatment target within the verb stimuli. The treatment targets in 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 are 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 target consonant or consonant cluster in the treated stimuli. Accuracy of the consonant or consonant cluster is binary, as 'incorrect' (e.g., "tee" for target "tree") or 'correct' (e.g., "tree" for target "tree").

    Change in percentage of consonant or consonant cluster accuracy (depending on Arm/Group) from first treatment session to final treatment session; up to 6 weeks.

  • Generalization Probe Accuracy Change

    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. The Generalization Probe samples each consonant and consonant cluster of the target language across multiple words and contexts. Children are asked to pronounce each word following presentation of a corresponding picture and a verbal prompt. Accuracy of the consonant or consonant cluster is binary, as 'incorrect' (e.g., "tee" for target "see") or 'correct' (e.g., "see" for target "see").

    Change in percent consonant accuracy from baseline to immediately following final treatment session; up to 6 weeks.

Study Arms (10)

Mono-morphemic Singleton PD

EXPERIMENTAL

Speech sound treatment on mono-morphemic singleton consonants for children with PD.

Behavioral: Phonological treatment

Mono-morphemic Singleton PD-SLI

EXPERIMENTAL

Speech sound treatment on mono-morphemic singleton consonants for children with PD-SLI.

Behavioral: Phonological treatment

Mono-morphemic Cluster PD

EXPERIMENTAL

Speech sound treatment on mono-morphemic consonant clusters for children with PD.

Behavioral: Phonological treatment

Mono-morphemic Cluster PD-SLI

EXPERIMENTAL

Speech sound treatment on mono-morphemic consonant clusters for children with PD-SLI.

Behavioral: Phonological treatment

Bi-morphemic Singleton PD

EXPERIMENTAL

Treatment on singletons in bi-morphemic contexts for children with PD.

Behavioral: Phonological treatment

Bi-morphemic Singleton PD-SLI

EXPERIMENTAL

Treatment on singletons in bi-morphemic contexts for children with PD-SLI.

Behavioral: Phonological treatmentBehavioral: Morpheme treatment

Bi-morphemic Cluster PD

EXPERIMENTAL

Treatment on bi-morphemic consonant clusters for children with PD.

Behavioral: Phonological treatment

Bi-morphemic Cluster PD-SLI

EXPERIMENTAL

Treatment on bi-morphemic consonant clusters for children with PD-SLI.

Behavioral: Phonological treatmentBehavioral: Morpheme treatment

Bi-morphemic Singleton SLI

EXPERIMENTAL

Treatment on singletons in bi-morphemic contexts for children with SLI.

Behavioral: Phonological treatmentBehavioral: Morpheme treatment

Bi-morphemic Cluster SLI

EXPERIMENTAL

Treatment on bi-morphemic consonant clusters for children with SLI.

Behavioral: Phonological treatmentBehavioral: Morpheme treatment

Interventions

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.

Bi-morphemic Cluster PDBi-morphemic Cluster PD-SLIBi-morphemic Cluster SLIBi-morphemic Singleton PDBi-morphemic Singleton PD-SLIBi-morphemic Singleton SLIMono-morphemic Cluster PDMono-morphemic Cluster PD-SLIMono-morphemic Singleton PDMono-morphemic Singleton PD-SLI

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.

Bi-morphemic Cluster PD-SLIBi-morphemic Cluster SLIBi-morphemic Singleton PD-SLIBi-morphemic Singleton SLI

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

San Diego State University Speech-Language Clinic

San Diego, California, 92182, United States

Location

Related Publications (20)

  • Combiths PN, Barlow JA, Potapova I, Pruitt-Lord S. Influences of Phonological Context on Tense Marking in Spanish-English Dual Language Learners. J Speech Lang Hear Res. 2017 Aug 16;60(8):2199-2216. doi: 10.1044/2017_JSLHR-L-16-0402.

    PMID: 28750415BACKGROUND
  • Pruitt S, Oetting J. Past tense marking by African American English-speaking children reared in poverty. J Speech Lang Hear Res. 2009 Feb;52(1):2-15. doi: 10.1044/1092-4388(2008/07-0176). Epub 2008 Aug 11.

    PMID: 18695014BACKGROUND
  • Cummings AE, Barlow JA. A comparison of word lexicality in the treatment of speech sound disorders. Clin Linguist Phon. 2011 Apr;25(4):265-86. doi: 10.3109/02699206.2010.528822. Epub 2010 Dec 15.

    PMID: 21158502BACKGROUND
  • Barlow JA. Phonological change and the representation of consonant clusters in Spanish: a case study. Clin Linguist Phon. 2005 Dec;19(8):659-79. doi: 10.1080/02699200412331279794.

    PMID: 16180282BACKGROUND
  • Pater J, Barlow JA. Constraint conflict in cluster reduction. J Child Lang. 2003 Aug;30(3):487-526.

    PMID: 14513466BACKGROUND
  • Gierut JA. Nexus to Lexis: Phonological Disorders in Children. Semin Speech Lang. 2016 Nov;37(4):280-290. doi: 10.1055/s-0036-1587704. Epub 2016 Oct 4.

    PMID: 27701704BACKGROUND
  • Gierut JA, Morrisette ML, Dickinson SL. Effect Size for Single-Subject Design in Phonological Treatment. J Speech Lang Hear Res. 2015 Oct;58(5):1464-81. doi: 10.1044/2015_JSLHR-S-14-0299.

    PMID: 26184118BACKGROUND
  • Gierut JA, Morrisette ML. Age of word acquisition effects in treatment of children with phonological delays. Appl Psycholinguist. 2012 Jan 1;33(1):121-144. doi: 10.1017/S0142716411000294.

    PMID: 22408279BACKGROUND
  • Gierut JA, Morrisette ML. Effect size in clinical phonology. Clin Linguist Phon. 2011 Nov;25(11-12):975-80. doi: 10.3109/02699206.2011.601392. Epub 2011 Jul 25.

    PMID: 21787149BACKGROUND
  • Gierut JA. Phonological complexity and language learnability. Am J Speech Lang Pathol. 2007 Feb;16(1):6-17. doi: 10.1044/1058-0360(2007/003).

    PMID: 17329671BACKGROUND
  • Gierut JA. Complexity in Phonological Treatment: Clinical Factors. Lang Speech Hear Serv Sch. 2001 Oct 1;32(4):229-241. doi: 10.1044/0161-1461(2001/021).

    PMID: 27764450BACKGROUND
  • Gierut JA. Syllable onsets: clusters and adjuncts in acquisition. J Speech Lang Hear Res. 1999 Jun;42(3):708-26. doi: 10.1044/jslhr.4203.708.

    PMID: 10391634BACKGROUND
  • Gierut JA, Champion AH. Syllable onsets II: three-element clusters in phonological treatment. J Speech Lang Hear Res. 2001 Aug;44(4):886-904. doi: 10.1044/1092-4388(2001/071).

    PMID: 11521781BACKGROUND
  • Van Horne AJO, Fey M, Curran M. Do the Hard Things First: A Randomized Controlled Trial Testing the Effects of Exemplar Selection on Generalization Following Therapy for Grammatical Morphology. J Speech Lang Hear Res. 2017 Sep 18;60(9):2569-2588. doi: 10.1044/2017_JSLHR-L-17-0001.

    PMID: 28796874BACKGROUND
  • Thompson CK, Shapiro LP. Complexity in treatment of syntactic deficits. Am J Speech Lang Pathol. 2007 Feb;16(1):30-42. doi: 10.1044/1058-0360(2007/005).

    PMID: 17329673BACKGROUND
  • Thompson CK. Complexity in language learning and treatment. Am J Speech Lang Pathol. 2007 Feb;16(1):3-5. doi: 10.1044/1058-0360(2007/002).

    PMID: 17329670BACKGROUND
  • Leonard LB, Deevy P. The Changing View of Input in the Treatment of Children With Grammatical Deficits. Am J Speech Lang Pathol. 2017 Aug 15;26(3):1030-1041. doi: 10.1044/2017_AJSLP-16-0095.

    PMID: 28586829BACKGROUND
  • Plante E, Ogilvie T, Vance R, Aguilar JM, Dailey NS, Meyers C, Lieser AM, Burton R. Variability in the language input to children enhances learning in a treatment context. Am J Speech Lang Pathol. 2014 Nov;23(4):530-45. doi: 10.1044/2014_AJSLP-13-0038.

    PMID: 24700145BACKGROUND
  • Leonard LB, Davis J, Deevy P. Phonotactic probability and past tense use by children with specific language impairment and their typically developing peers. Clin Linguist Phon. 2007 Oct;21(10):747-58. doi: 10.1080/02699200701495473.

    PMID: 17882693BACKGROUND
  • Potapova I, Kelly S, Combiths PN, Pruitt-Lord SL. Evaluating English Morpheme Accuracy, Diversity, and Productivity Measures in Language Samples of Developing Bilinguals. Lang Speech Hear Serv Sch. 2018 Apr 5;49(2):260-276. doi: 10.1044/2017_LSHSS-17-0026.

    PMID: 29621805BACKGROUND

MeSH Terms

Conditions

Language Development DisordersSpeech Sound Disorder

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Limitations and Caveats

The pandemic prevented continuing research in-person and we transitioned to a teletherapy protocol, completed via Zoom. Given this new approach, we found that prioritizing only two arms was most feasible in a telehealth format, given that more time and resources had to be dedicated for each participant. Participants in the Bi-morphemic Singleton PD-SLI and Bi-morphemic Cluster PD-SLI conditions discontinued due to the onset of the pandemic and we removed those Arms/Groups going forward.

Results Point of Contact

Title
Dr Jessica Barlow, Principal Investigator
Organization
San Diego State University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 6, 2019

Study Start

June 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 9, 2023

Results First Posted

March 9, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations