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CompletedNCT06945289Updated Feb 5, 2026

Efficacy of Let's Know! First Grade

An interventional study of Let's Know! in Developmental Language Disorder and Language Impairment, sponsored by Arizona State University. Completed at 1 site in United States. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Arizona State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
6 Years to 8 Years
Sex
All
01

Study 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.

Read the detailed description

Oral language skills, which consist of both lower-level (vocabulary and grammar) and higher-level skills (inferencing, comprehension monitoring, and text structure knowledge) are crucial for reading comprehension. Children with low oral language skills are at increased risk for negative academic outcomes due to their deficits in understanding and producing language. Multi-component interventions have shown positive effects for improving language comprehension and reading comprehension outcomes of children with typical development and at-risk for language and literacy disorders, and thus may benefit children with low oral language skills.

The purpose of this study is to examine the efficacy of Let's Know!, a small group multi-component intervention, for improving language comprehension skills in first-grade students with low oral language skills. A randomized controlled trial will be employed to compare the language comprehension outcomes for a treatment group compared to a business-as-usual control group.

02

Conditions studied

  • Developmental Language Disorder and Language Impairment

Keywords

  • developmental language disorder
  • language intervention
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In context

Language Development Disorders

121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.

This study's enrollment of 22 is below the median of 74 across 106 interventional studies indexed under Language Development Disorders.

Browse Language Development Disorders studies →

Lead sponsor

Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • cannot be enrolled in English-Language Learner services in the school.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Intervention

    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

  • BehavioralLet's Know!

    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.

06

What researchers measure

Primary outcomes

  1. Curriculum-Aligned Vocabulary Measure

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

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

  2. Curriculum-Aligned Inferencing Measure

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

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

  3. 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.

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

  4. 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.

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

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Study locations

1 site
  • Arizona State University
    Tempe, Arizona 85282, United States
08

References and documents

Individual participant data

Plan to share: No — In our parent consent form, we did not specify that individual participant data would be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06945289
Responsible party
R.J. Risueño (Principal Investigator, Arizona State University) — Principal investigator
First posted
Apr 25, 2025
Start date
Oct 1, 2024
Primary completion
Apr 30, 2025
Completion
Aug 31, 2025
Last update
Feb 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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