Recruiting

Developmental Framework

Sponsor:

Father Flanagan's Boys' Home

Code:

NCT04558541

Conditions

Developmental Language Disorder

Speech Sound Disorder

Specific Language Impairment

Eligibility Criteria

Sex: All

Age: 4 - 8

Healthy Volunteers: Accepted

Interventions

Sensitivity to phonological rules

Sensitivity to semantic category cues.

Study Details

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.

Conditions

Developmental Language Disorder

Speech Sound Disorder

Specific Language Impairment

Study ID

NCT04558541

Start date

Aug 7, 2022

Status verified date

Oct, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 8

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Performance on the following measures will serve as covariates and will not be exclusionary for DLD or SSD:

  • 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.

Exclusion Criteria for all participants:

  • Hearing impairment
  • Intellectual impairment
  • Autism
  • Significant motor impairment.

Typical participants will be excluded if they show:

-Histories of developmental, speech, language, or hearing disorders.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Sensitivity to phonological rules: Children

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

experimental: Sensitivity to semantic category cues: Children

Arm 1.Referential cue during OR learning.

Interventions

Sensitivity to phonological rules

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 semantic category cues.

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

Primary outcome measure

  • Transcription Accuracy Measures of Children's Sensitivity to OR/disjunction, Family resemblance/prototype and/or Single feature rules [ Time Frame: 30 minutes ]
  • Transcription Variability Measures of Children's Sensitivity to OR/disjunction, Family resemblance/prototype and/or Single feature rules [ Time Frame: 30 minutes ]
  • Articulatory Variability Measures of Children's Sensitivity to OR/disjunction, Family resemblance/prototype and/or Single feature rules [ Time Frame: 30 minutes ]
  • Acoustic Measures of Children's Sensitivity to OR/disjunction, Family resemblance/prototype and/or Single feature rules [ Time Frame: 30 minutes ]
  • Transcription Accuracy Measures of Children's Sensitivity to OR/disjunction with the inclusion of a semantic category cue. [ Time Frame: 30 minutes ]
  • Transcription Variability Measures of Children's Sensitivity to OR/disjunction with the inclusion of a semantic category cue. [ Time Frame: 30 minutes ]
  • Articulatory Variability Measures of Children's Sensitivity to OR/disjunction with the inclusion of a semantic category cue. [ Time Frame: 30 minutes ]
  • Acoustic Variability Measures of Children's Sensitivity to OR/disjunction with the inclusion of a semantic category cue. [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Lisa Goffman, PhD

531-355-5038lisa.goffman@boystown.org

LouAnn Gerken, PhD

gerken@email.arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85721

Contacts

LouAnn Gerken, PhD

gerken@arizona.edu

Boys Town National Research Hospital

Recruiting

Omaha, Nebraska, United States, 68131

Contacts

Lisa Goffman, PhD

lisa.goffman@boystown.org

More Information

Sponsor

Father Flanagan's Boys' Home

Last update posted

Oct 27, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Father Flanagan's Boys' Home on 2025-10-27.