NCT04531514

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
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
4.7 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

August 20, 2020

Last Update Submit

October 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Toddlers' ability to learn different types of sound patterns measured by listening times

    Learning will be assessed during the generalization phase. First, each toddler will be given a difference score resulting from mean listening time for consistent minus mean listening time for inconsistent test trials. It is predicted that toddlers will show increased learning of the OR rule in the non-referential condition. Higher vocabulary on the CDI will correspond with weaker performance.

    Generalization Phase which will last 3-5 minutes

Study Arms (2)

Sensitivity to phonological rules & referents OR: Toddlers

EXPERIMENTAL

OR condition

Other: Sensitivity to phonological rules & referents OR: Toddlers

Sensitivity to phonological rules & referents FR: Toddlers

EXPERIMENTAL

Family Resemblance condition

Other: Sensitivity to phonological rules & referents FR: Toddlers

Interventions

Assess whether the inclusion of a semantic reference decreases OR phonological rule learning

Sensitivity to phonological rules & referents OR: Toddlers

Assess whether the inclusion of a semantic reference increases FR phonological rule learning

Sensitivity to phonological rules & referents FR: Toddlers

Eligibility Criteria

Age19 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Toddlers will, based on parent case history report, have
  • normal hearing
  • no medical or developmental concerns
  • Language, speech, social, and motor development will be reported as within the expected range
  • dominant exposure to English from infancy
  • expressive vocabulary above the 10th percentile on the MacArthur-Bates Communicative Development Inventory (CDI; Fenson et al., 2006).

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 (1)

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
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
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
SINGLE GROUP
Model Details: 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

August 20, 2020

First Posted

August 28, 2020

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