NCT05325333

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 wellbeing. 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 our previous work to determine whether, as we have found thus far, special benefits accrue when these children must frequently recall newly introduced words during the course of learning. In this first of a series of studies, we seek to increase the children's absolute levels of learning while maintaining the advantage that repeated retrieval holds over comparison methods of learning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 30, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

April 5, 2022

Results QC Date

November 21, 2024

Last Update Submit

August 12, 2025

Conditions

Keywords

Word learningWord retrievalPreschool-aged children

Outcome Measures

Primary Outcomes (5)

  • Word Form Recall Accuracy (Number of Words Correctly Recalled) on Expanding and Standard Retrieval Schedules at 5 Mins

    Five minutes after second learning session, child is asked to recall and say the word associated with each novel referent learned under one of two conditions: one in which retrieval trials occurred on an expanding schedule and one in which retrieval trials occurred on the standard schedule.

    5 minutes after end of learning period

  • Word Form Recall Accuracy (Number of Words Correctly Recalled) on Expanding and Standard Retrieval Schedules at One Week

    One week after end of learning sessions, child is asked to recall and say the word associated with each novel referent learned under one of two conditions: one in which retrieval trials occurred on an expanding schedule and one in which retrieval trials occurred on the standard schedule.

    1 week after end of learning period

  • Word Meaning Recall Accuracy (Number of Semantic Associations Correctly Recalled) on Expanding and Standard Retrieval Schedules at 5 Mins

    Five minutes after end of learning sessions, child is asked to recall and say the semantic information associated with each novel referent learned under one of two conditions: one in which retrieval trials occurred on an expanding schedule and one in which retrieval trials occurred on the standard schedule.

    5 minutes after end of learning period

  • Word Meaning Recall Accuracy (Number of Semantic Associations Correctly Recalled) on Expanding and Standard Retrieval Schedules at One Week

    One week after end of learning sessions, child is asked to recall and say the semantic information associated with each novel referent learned under one of two conditions: one in which retrieval trials occurred on an expanding schedule and one in which retrieval trials occurred on the standard schedule.

    1 week after end of learning period

  • Word Recognition (Number of Words Accurately Identified) on Expanding Condition and Standard Retrieval Schedules

    Upon hearing a novel word, the child is asked to indicate (by pointing) which picture among 4 options is referred to; for words learned under the Expanding condition.

    1 week after end of learning period

Secondary Outcomes (2)

  • Peabody Picture Vocabulary Test - Fifth Edition

    Test completed at start of study

  • Maternal Education in Years

    Information collected at start of study

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: Expanding retrieval practice scheduleBehavioral: Retrieval-based word learning: Standard retrieval practice schedule

Children with typical language development

EXPERIMENTAL

Children whose language development is as expected for their age.

Behavioral: Retrieval-based word learning: Expanding retrieval practice scheduleBehavioral: Retrieval-based word learning: Standard retrieval practice schedule

Interventions

Learning sessions: Novel nouns and their meanings are practiced on Day 1. Retrieval trials will initially be immediate. In the expanding condition, the next two retrieval trials will each occur after 1 intervening word and then after 3 intervening words for the remainder of the session. This practice schedule is repeated the next day (Day 2).

Children with Developmental Language DisorderChildren with typical language development

Learning sessions: Novel nouns and their meanings are practiced on Day 1. Retrieval trials will initially be immediate. In the standard condition, all remaining retrieval trials will occur after 3 intervening words. This practice schedule is repeated the next day (Day 2).

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

Location

MeSH Terms

Conditions

Language Development DisordersSpecific Language Disorder

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Patricia Deevy, Research Associate
Organization
Purdue University

Study Officials

  • Laurence B. Leonard, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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. The clinical group (children with DLD) is compared to the control group (children with Typical development) on these two word learning conditions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Speech, Language, & Hearing Sciences

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 13, 2022

Study Start

March 16, 2022

Primary Completion

February 12, 2024

Study Completion

February 12, 2024

Last Updated

August 29, 2025

Results First Posted

May 30, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Data that contribute to our final published results will be made available at clinicaltrials.gov. Data will include de-identified 5 minute and one-week form and meaning recall scores and one-week recognition scores, as well as children's age in months at time of study participation, standardized PPVT scores and an SES measure (years of maternal education).

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-idientified data will be made publicly available at clinicaltrials.gov

Locations