NCT04996472

Brief Summary

This 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; AKA specific language impairment). Other populations, such as at-risk toddlers, may also benefit from this new approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
933

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

August 3, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2025

Completed
Last Updated

October 27, 2025

Status Verified

October 1, 2025

Enrollment Period

4.8 years

First QC Date

July 22, 2021

Last Update Submit

October 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Adults' ability to learn different types of sound patterns measured by percent correct pattern identification at test

    After familiarization, adults will hear 16 test words (8 consistent and 8 inconsistent) and will judge whether each word was consistent or inconsistent with the alien language to which they were exposed. Learning is indexed based on judgment of consistent vs. inconsistent nonwords, with percent correct (saying "consistent" to truly consistent and "inconsistent" to truly inconsistent) as the dependent measure.

    The assessment will be conducted immediately following the intervention

  • Adults' ability to learn different types of sound patterns with semantic cue measured by percent correct pattern identification at test

    After familiarization, adults will hear 16 test words (8 consistent and 8 inconsistent) and will judge whether each word was consistent or inconsistent with the alien language to which they were exposed. Learning is indexed based on judgment of consistent vs. inconsistent nonwords, with percent correct (saying "consistent" to truly consistent and "inconsistent" to truly inconsistent) as the dependent measure.

    The assessment will be conducted immediately following the intervention

Study Arms (2)

Sensitivity to phonological rules: Adults

EXPERIMENTAL

Arm 1: Single Feature Pattern; Arm 2: OR/Disjunction Pattern

Behavioral: Sensitivity to phonological rules: Adults

Sensitivity to semantic category cues: Adults

EXPERIMENTAL

Arm 1. Referential cue during OR learning.

Behavioral: Sensitivity to semantic category cues: Adults

Interventions

Assess whether adults are sensitive to different phonological patterns that are predicted to align with development of morphosyntax or the lexicon.

Sensitivity to phonological rules: Adults

Assess whether adults show improved learning of OR or family resemblance rules when a semantic category cue is used.

Sensitivity to semantic category cues: Adults

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults will have
  • normal hearing
  • will report no medical, educational, or developmental concerns in their case histories
  • no history of speech, language, or hearing difficulties will be reported
  • dominant exposure to English from infancy

You may not qualify if:

  • Participants will be excluded who have
  • hearing impairment
  • intellectual impairment
  • autism
  • significant motor impairment
  • reported 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

Location

Boys Town Hospital

Omaha, Nebraska, 68131, United States

Location

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

Study Officials

  • Lisa Goffman, PhD

    Father Flanagan's Boys' Home

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants 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: Adults will complete case history, language history, and hearing screening. 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. Adults will participate in an experimental session, which includes exposure to the rule followed by a generalization test. A sub-group will participate in the Referential Study. Parents of the toddlers will fill out the expressive language MacArthur-Bates Communicative Development Inventory and also a case history. Toddlers will be assigned randomly to one of four conditions: OR condition with a referent; OR condition without a referent; Family Resemblance condition with a referent; Family Resemblance condition without a referent.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

July 22, 2021

First Posted

August 9, 2021

Study Start

August 3, 2020

Primary Completion

May 17, 2025

Study Completion

May 17, 2025

Last Updated

October 27, 2025

Record last verified: 2025-10

Locations