NCT04558541

Brief Summary

The broad aim of this clinical study is to assess the hypothesis that morphological and phonological deficits are linked by a broader deficit in sequential pattern learning. This hypothesis applies to learning in general, but is especially critical as an avenue for developing earlier assessments and more powerful interventions for children with developmental language disorder (DLD; also known as specific language impairment). Other populations, such as at-risk toddlers, may also benefit from this new approach.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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 Progress85%
Aug 2022Dec 2026

First Submitted

Initial submission to the registry

August 22, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

August 7, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 27, 2025

Status Verified

October 1, 2025

Enrollment Period

4.4 years

First QC Date

August 22, 2020

Last Update Submit

October 24, 2025

Conditions

Outcome Measures

Primary Outcomes (8)

  • Transcription Accuracy Measures of Children's Sensitivity to OR/disjunction, Family resemblance/prototype and/or Single feature rules

    Learning shown via changes in transcription accuracy

    30 minutes

  • Transcription Variability Measures of Children's Sensitivity to OR/disjunction, Family resemblance/prototype and/or Single feature rules

    Learning shown via changes in transcription based syllable co-occurrence variability

    30 minutes

  • Articulatory Variability Measures of Children's Sensitivity to OR/disjunction, Family resemblance/prototype and/or Single feature rules

    Learning shown via changes in articulatory variability (articulatory spatiotemporal variability)

    30 minutes

  • Acoustic Measures of Children's Sensitivity to OR/disjunction, Family resemblance/prototype and/or Single feature rules

    Learning shown via changes in acoustic variability (Acoustic spatiotemporal variability)

    30 minutes

  • Transcription Accuracy Measures of Children's Sensitivity to OR/disjunction with the inclusion of a semantic category cue.

    Learning shown via changes in transcription accuracy

    30 minutes

  • Transcription Variability Measures of Children's Sensitivity to OR/disjunction with the inclusion of a semantic category cue.

    Learning shown via changes in transcription based syllable co-occurrence variability

    30 minutes

  • Articulatory Variability Measures of Children's Sensitivity to OR/disjunction with the inclusion of a semantic category cue.

    Learning shown via changes in articulatory variability (articulatory spatiotemporal variability)

    30 minutes

  • Acoustic Variability Measures of Children's Sensitivity to OR/disjunction with the inclusion of a semantic category cue.

    Learning shown via changes in acoustic variability (acoustic spatiotemporal variability)

    30 minutes

Study Arms (2)

Sensitivity to phonological rules: Children

EXPERIMENTAL

Arm 1: Single Feature Pattern; Arm 2: OR/Disjunction Pattern; Arm 3: Family Resemblance/Prototype Pattern

Other: Sensitivity to phonological rules

Sensitivity to semantic category cues: Children

EXPERIMENTAL

Arm 1.Referential cue during OR learning.

Other: Sensitivity to semantic category cues.

Interventions

Assess whether children with developmental language disorder (DLD) are sensitive to different phonological patterns that are predicted to align with development of morphosyntax or the lexicon; children with speech sound disorder (SSD) are not predicted to be sensitive to the same phonological patterns.

Sensitivity to phonological rules: Children

Assess whether all children, including those with DLD, show improved learning of OR rules when a semantic category cue is used.

Sensitivity to semantic category cues: Children

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Because clinical precision is required, 4- to 8-year-olds will complete a large test battery.
  • All children (TD, DLD, DLD + SSD, SSD) will score above 75 on the Nonverbal Scale of the Kaufman Assessment Battery for Children (KABC-II), which is above the Diagnostic and Statistical Manual cut-off for intellectual disability, even considering the standard error of measurement.
  • Hearing will be within normal limits
  • Oral structures will be within normal limits (Robbins \& Klee, 1987).
  • The Childhood Autism Rating Scale (Schopler et al., 2010) and parent report, will be used to rule out autism.
  • Children with DLD will meet standard criteria.
  • Children with DLD will score below the cutoff of 87 on the Structured Photographic Expressive Language Test-P2 (SPELT-P2; Dawson et al., 2005) that has demonstrated high diagnostic accuracy for DLD.
  • Children with DLD will perform below 80% in their spontaneous production of finite verb morphemes.
  • Performance on a nonword repetition task will also support DLD status. Scores below 70% for total phonemes correct across all nonword lengths are greater than 1 SD below the mean for typical children.
  • Speech production skills will be measured via the Goldman-Fristoe Test of Articulation-3 (GFTA-3; Goldman \& Fristoe, 2015) and the inconsistency subtest of the Diagnostic Evaluation of Articulation and Phonology (DEAP, Dodd, et al., 2006). Many 4- to 6-year-old children with DLD are expected to perform below expected levels on the GFTA-3; for this study half of the children with DLD will show performance below expected levels and half above a standard score of 85. Children with SSD will show impaired performance on the GFTA-3, but typical performance on grammatically weighted language measures (SPELT-P2 and finite verb morphemes). The DEAP serves as a standardized measure of segmental inconsistency and will provide a post hoc analysis that may be related to sequence pattern variability.
  • Peabody Picture Vocabulary Test, 4th ed (Dunn \& Dunn, 1997)
  • Expressive Vocabulary Test, 2nd ed (Williams, 1997)
  • Verbal and nonverbal memory span.
  • Because of the emphasis on English phonological and morpho-syntactic patterns, all participants will be monolingual English learners or report dominant exposure to English from infancy. Exposure to other languages will be documented.

You may not qualify if:

  • Hearing impairment
  • Intellectual impairment
  • Autism
  • Significant motor impairment.
  • Typical participants will be excluded if they show:
  • Histories of developmental, speech, language, or hearing disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arizona

Tucson, Arizona, 85721, United States

RECRUITING

Boys Town National Research Hospital

Omaha, Nebraska, 68131, United States

RECRUITING

MeSH Terms

Conditions

Language Development DisordersSpeech Sound DisorderSpecific Language Disorder

Condition Hierarchy (Ancestors)

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

Central Study Contacts

LouAnn Gerken, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants and care providers will not be told which condition they are participating in. Investigators will know because of familiarity with the stimuli.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: For children, assessments will determine group assignment. Participants will be randomly assigned to a condition, reflecting each of the 3 phonological patterns (Single Feature, OR, Family Resemblance). Randomization will occur within groups and will be generated a priori. Children will participate in testing and an experimental session, which includes exposure to the rule followed by a generalization test. A sub-group will participate in the Referential Study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist and Endowed Chair

Study Record Dates

First Submitted

August 22, 2020

First Posted

September 22, 2020

Study Start

August 7, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 27, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations