- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06945289
Efficacy of Let's Know! First Grade
Efficacy of Let's Know! for Improving Oral Language in First Grade Students
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Arizona
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Tempe, Arizona, United States, 85282
- Arizona State University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
2 units of a multicomponent intervention to improve vocabulary, text structure knowledge, inferencing, and comprehension monitoring within narrative and expository texts.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Curriculum-Aligned Vocabulary Measure
Time Frame: From enrollment to the end of treatment at 10 weeks of intervention.
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Vocabulary measure to assess participants' knowledge of 16 vocabulary words taught during the intervention.
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From enrollment to the end of treatment at 10 weeks of intervention.
|
|
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.
|
From enrollment to the end of treatment at 10 weeks of intervention.
|
|
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.
|
From enrollment to the end of treatment at 10 weeks of intervention.
|
|
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.
|
From enrollment to the end of treatment at 10 weeks of intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00020398
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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