Developmental Language Disorder and Language ImpairmentNCT06945289
Efficacy of Let's Know! First Grade
A study testing Let's Know! in people with Developmental Language Disorder and Language Impairment, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorder and Language Impairment
- What is being tested?
- Let's Know!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- cannot be enrolled in English-Language Learner services in the school.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Being tested
- Let's Know!
- Keywords
- developmental language disorder, language intervention
- Medical subject headings
- Language Development Disorders, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let's Know!Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 2 units of a multicomponent intervention to improve vocabulary, text structure knowledge, inferencing, and comprehension monitoring within narrative and expository texts. Receives: Behavioral: Let's Know! |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curriculum-Aligned Vocabulary Measure
Vocabulary measure to assess participants' knowledge of 16 vocabulary words taught during the intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 10 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Oct 2024
- Primary completion30 Apr 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language Disorder and Language ImpairmentStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R.J. Risueño, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945289
- Sponsor's protocol ID
- STUDY00020398
- Status last verified
- Feb 2026
- First submitted
- 12 Dec 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In our parent consent form, we did not specify that individual participant data would be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Let's Know! for Improving Oral Language in First Grade Students
- ClinicalTrials.gov ID
- NCT06945289
- Acronym / sponsor ID
- STUDY00020398
- Keywords
- developmental language disorder, language intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Let's Know!2 units of a multicomponent intervention to improve vocabulary, text structure knowledge, inferencing, and comprehension monitoring within narrative and expository texts. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- cannot be enrolled in English-Language Learner services in the school.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Let'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. | Behavioural | Intervention |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No. In our parent consent form, we did not specify that individual participant data would be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let's Know! in people with Developmental Language Disorder and Language Impairment, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Curriculum-Aligned Vocabulary Measure (time frame: From enrollment to the end of treatment at 10 weeks of intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.