NCT03586479

Brief Summary

Children with Specific Language Impairment (SLI) are slower to learn new words than their peers, placing them at risk for academic failure. In this study, we are improving a storybook reading treatment to help Kindergarten children with SLI learn new words. In this study, we compare three versions of book reading that vary in how often children are tested on, meaning asked to talk about, the words they are learning in the book: low vs. mid vs. high testing. We then examine which version of the treatment leads to better learning of the words during treatment and remembering of the words after treatment. We also seek to understand individual differences in treatment outcomes by examining pre-treatment predictors as well as progress during and after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

July 2, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

December 2, 2025

Completed
Last Updated

December 2, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

July 2, 2018

Results QC Date

October 1, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

Vocabulary

Outcome Measures

Primary Outcomes (1)

  • Change in Definition Scores From Pre- to 12-weeks Post-treatment

    This outcome measure indicates the total number of words children responded to correctly at post-test after subtracting the total number of words correct at pre-test. For the definition scores, this includes the total number of words that the child provided correct definitions for at post-test minus the number of words that the child provided correct definition scores at pre-test. For each child, there was a total of 30 taught words and 30 untaught words. Thus, for all word learning outcomes the range is 0-30. For all assessments of word learning, higher values represent a better outcome. In this study, the subscales are not combined into a total score.

    20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment

Secondary Outcomes (1)

  • Change in Naming Scores From Pre- to 12-weeks Post-treatment

    20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment

Other Outcomes (1)

  • Change in Untaught Vocabulary

    10 weeks: pre-treatment, treatment (7.5 weeks), immediate post-treatment

Study Arms (3)

Low Testing

EXPERIMENTAL

Children will receive 0 testing (talking) exposures and 6 listening exposures for a total of 6 exposures to each word. This is a listening only condition with minimal testing.

Behavioral: Interactive storybook reading

Mid Testing

EXPERIMENTAL

Children will receive 2 testing (talking) exposures and 4 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly listening.

Behavioral: Interactive storybook reading

High Testing

EXPERIMENTAL

Children will receive 4 testing (talking) exposures and 2 listening exposures for a total of 6 exposures to each word. This is a listening and talking condition with mostly talking.

Behavioral: Interactive storybook reading

Interventions

Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.

Also known as: interactive book reading, dialogic reading
High TestingLow TestingMid Testing

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Eligible for kindergarten enrollment Age 5-6 years Normal hearing Normal nonverbal IQ -- Nonverbal IQ of 85 or higher Language impairment as documented by language score \</= 94 on SPELT-3 or \</=91 on TNL-2 Vocabulary impairment as documented by a vocabulary score \</= 6 on DELV, \</= 6 on CELF-4 Word Classes, \</= 6 on CCC-2

You may not qualify if:

  • Speaks more than one language Health history indicating neurologic or other disorder that would exclude a diagnosis of SLI (e.g., autism, developmental disability)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas

Lawrence, Kansas, 66045, United States

Location

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

We excluded the data from 8 children from analyses whose testing schedules were disrupted due to the 2020 pandemic. These children finished the clinical trial, however, because the primary questions of this study focused on learning rates and forgetting rates, and the schedule for these children differed substantially from the other children, we elected to exclude their data as their treatment schedules would not capture learning and retention rates on the same schedule as other children.

Results Point of Contact

Title
Rebecca Swinburne Romine
Organization
University of Kansas

Study Officials

  • Rebecca E Swinburne Romine, PhD

    University of Kansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Pre- and post-outcome assessments will be performed by an individual blind to arm assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Children will be randomly assigned to one of three treatment arms
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 13, 2018

Study Start

July 2, 2018

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

December 2, 2025

Results First Posted

December 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

De-identified pre-treatment test scores and pre-, during, and post-treatment outcome measures will be included as supplemental material to publications. All study information will be shared as supplemental material to publication or upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will become available as findings are published (in conjunction with publication)
Access Criteria
Data will be open access

Locations