NCT07048392

Brief Summary

Children with developmental language disorder (DLD; also referred to as specific language impairment) experience a significant deficit in language ability that is longstanding and harmful to the children's academic, social, and eventual economic well-being. Word learning is one of the principal weaknesses in these children. This project focuses on the word learning abilities of four- and five-year-old children with DLD. The goal of the project is to build on the investigators' previous work to determine whether, as has been found thus far, special benefits accrue when these children must frequently recall newly introduced words during the course of learning. In this study, the investigators seek to replicate the advantage that repeated retrieval holds over simple exposure to the words appearing in the context of a story book by increasing the degree to which the words are integrated into the story line.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

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 Progress84%
Mar 2025Jul 2026

Study Start

First participant enrolled

March 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

June 24, 2025

Last Update Submit

July 3, 2025

Conditions

Keywords

word learningword retrievalpreschool-aged children

Outcome Measures

Primary Outcomes (7)

  • Word Form Recall Accuracy (number of words correctly recalled) in Repeated Spaced Retrieval and Repeated Study conditions, Day 1

    Child is asked to recall and say the word associated with each novel referent.

    5 minutes after end of first (Day 1) learning period

  • Word Form Recall Accuracy (number of words correctly recalled) in Repeated Spaced Retrieval and Repeated Study conditions, Day 2

    Child is asked to recall and say the word associated with each novel referent.

    5 minutes after end of first (Day 2) learning period

  • Word Form Recall Accuracy (number of words correctly recalled) in Repeated Spaced Retrieval and Repeated Study conditions, One week

    Child is asked to recall and say the word associated with each novel referent.

    One week after end of learning period

  • Word Meaning Recall Accuracy (number of semantic associations correctly recalled) in Repeated Spaced Retrieval and Repeated Study conditions, Day 1

    Child is asked to recall and say semantic information associated with the novel referent.

    5 minutes after end of first (Day 1) learning period

  • Word Meaning Recall Accuracy (number of semantic associations correctly recalled) in Repeated Spaced Retrieval and Repeated Study conditions, Day 2

    Child is asked to recall and say semantic information associated with the novel referent.

    5 minutes after end of first (Day 2) learning period

  • Word Meaning Recall Accuracy (number of semantic associations correctly recalled) in Repeated Spaced Retrieval and Repeated Study conditions, one week

    Child is asked to recall and say semantic information associated with the novel referent.

    One week after end of learning period

  • Word recognition (number of words accurately identified) in repeated spaced retrieval and repeated study conditions.

    Upon hearing a novel word, the child is asked to indicate (by pointing) which picture among 4 options is referred to.

    One week after end of learning period

Study Arms (2)

Children with Developmental Language Disorder

EXPERIMENTAL

These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.

Behavioral: Retrieval-based word learning: Repeated Spaced Retrieval conditionBehavioral: Retrieval-based word learning: Repeated Study condition

Children with typical language development

EXPERIMENTAL

Children whose language development is as expected for their age.

Behavioral: Retrieval-based word learning: Repeated Spaced Retrieval conditionBehavioral: Retrieval-based word learning: Repeated Study condition

Interventions

Each child will learn 8 novel nouns referring to unfamiliar plants and animals ("nepp") and a related "meaning" ("a nepp likes rain") in the context of a story book. Four of the nouns will be will be learned using repeated spaced retrieval. In this condition, they will initially hear the information and be asked to retrieve it. Thereafter, they will be asked to retrieve it after hearing 3 intervening words. After each retrieval attempt, they will hear the target information again. This procedure will occur on two consecutive days.

Children with Developmental Language DisorderChildren with typical language development

Each child will learn 8 novel nouns referring to unfamiliar plants and animals ("nepp") and a related "meaning" ("a nepp likes rain") in the context of a story book. Four of the nouns will be will be learned using repeated study trials only (with no retrieval practice). In this condition, they will simply hear the information (word \& meaning) as part of the story. This procedure will occur on two consecutive days.

Children with Developmental Language DisorderChildren with typical language development

Eligibility Criteria

Age48 Months - 71 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • a significant deficit in language ability (language test score below cutoff for best sensitivity/specificity) or documented age-appropriate language ability.
  • normal hearing.
  • no evidence of neurological damage or disease.
  • scores on tests of nonverbal intelligence above the intellectual disability range
  • not within Autistic range on Autism screening test
  • native English speaker (can be bilingual)

You may not qualify if:

  • failed hearing screening
  • known neurological damage or disease
  • scores on tests of nonverbal intelligence below the intellectual disability range (standard score less than 75)
  • autism spectrum disorder
  • non-native English speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

RECRUITING

MeSH Terms

Conditions

Language Development DisordersLanguage DisordersSpecific Language Disorder

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLearning DisabilitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Laurence B. Leonard, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia L Deevy, PhD

CONTACT

Laurence B Leonard, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Model Details: Within-participant design in which each child learns words under two conditions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 2, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

July 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Data that contribute to our final published results will be made available at clinicaltrials.gov.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will become available after the results are published or within 12 months from the primary completion date (i.e., the date of final data collection for the primary outcome measure).
Access Criteria
De-identified data will be made publicly available at www.clinicaltrials.gov

Locations