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OpenTrials
Completed

NCT Number: NCT06945289

Efficacy of Let's Know! First Grade

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.

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Key information

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Tempe, Arizona, 85282, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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.

Primary outcomes

  1. Curriculum-Aligned Vocabulary Measure

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

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

  2. Curriculum-Aligned Inferencing Measure

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

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

  3. Curriculum-Aligned Comprehension Monitoring Measure

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

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

  4. Curriculum-Aligned Text Structure Knowledge Measure

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

    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.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

Efficacy of Let's Know! for Improving Oral Language in First Grade Students

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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