NCT04558541 A Developmental Framework For Linking Phonological And Morpho-syntactic Sequential Pattern Rules In DLD: Production
| NCT ID | NCT04558541 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Father Flanagan's Boys' Home |
| Condition | Developmental Language Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-08-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2022-08-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04558541 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 8 Years, studying Developmental Language Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04558541 currently recruiting?
Yes, NCT04558541 is actively recruiting participants. Contact the research team at lisa.goffman@boystown.org for enrollment information.
Where is the NCT04558541 trial being conducted?
This trial is being conducted at Tucson, United States, Omaha, United States.
Who is sponsoring the NCT04558541 clinical trial?
NCT04558541 is sponsored by Father Flanagan's Boys' Home. The trial plans to enroll 400 participants.