NCT06945289

Brief Summary

Oral language skills are vital for reading comprehension. Some children, however, are at increased risk for reading comprehension difficulties due to underlying oral language deficits. School-based interventions that target children's abilities to understand and produce spoken language have shown positive effects for improving language and reading comprehension of children with typical development and those at-risk for language disorders, so it is likely that they will benefit children with low oral language skills. The purpose of this study is to examine the efficacy of a small-group intervention for improve language skills in first grade students with low oral language skills.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

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

October 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

December 12, 2024

Last Update Submit

February 3, 2026

Conditions

Keywords

developmental language disorderlanguage intervention

Outcome Measures

Primary Outcomes (4)

  • Curriculum-Aligned Vocabulary Measure

    Vocabulary measure to assess participants' knowledge of 16 vocabulary words taught during the intervention.

    From enrollment to the end of treatment at 10 weeks of intervention.

  • Curriculum-Aligned Inferencing Measure

    This measure will examine students' knowledge of making inferences through narrative texts. There are 16 total questions for this measure.

    From enrollment to the end of treatment at 10 weeks of intervention.

  • Curriculum-Aligned Comprehension Monitoring Measure

    This is a curriculum-aligned measure of comprehension monitoring strategies taught during intervention. There are 4 total questions for this measure.

    From enrollment to the end of treatment at 10 weeks of intervention.

  • Curriculum-Aligned Text Structure Knowledge Measure

    This is a curriculum-aligned measure of text structure knowledge taught during the intervention. The participant is read a story, is asked to retell the story, and then is asked 3 questions about main events. This occurs twice for a total of 2 retells and 6 comprehension questions.

    From enrollment to the end of treatment at 10 weeks of intervention.

Study Arms (1)

Intervention

EXPERIMENTAL

2 units of a multicomponent intervention to improve vocabulary, text structure knowledge, inferencing, and comprehension monitoring within narrative and expository texts.

Behavioral: Let's Know!

Interventions

Let's Know!BEHAVIORAL

This intervention is modified from a whole-classroom intervention by LARRC, 2018 and modified by Hogan et al. used in a larger NIH R01 investigation. We are examining the efficacy of the first two units used by Hogan et al.

Intervention

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • enrolled in first-grade;
  • receive a score of below than 5 on two items on the Student Language Scale (Nelson et al., 2018) or be receiving school speech-language services for language impairment;
  • be proficient in English, per caregiver report;
  • have no other neurological impairments (e.g., intellectual disability, autism) per parent report;
  • have corrected vision;
  • no hearing impairment.

You may not qualify if:

  • cannot be enrolled in English-Language Learner services in the school.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Tempe, Arizona, 85282, United States

Location

MeSH Terms

Conditions

Language Development DisordersLanguage Disorders

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 12, 2024

First Posted

April 25, 2025

Study Start

October 1, 2024

Primary Completion

April 30, 2025

Study Completion

August 31, 2025

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

In our parent consent form, we did not specify that individual participant data would be shared.

Locations