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Let's Know!2: Language-focused Intervention for Children at Risk of Comprehension Difficulties
NCT05133479 · View on ClinicalTrials.gov ↗
Study Summary
In the proposed project, the investigators will conduct a multisite randomized controlled trial (RCT) to determine the efficacy of Let's Know!2, a small-group, language focused comprehension intervention, on children's lower- and higher-level language skills and comprehension skills in the short- and long-term (Specific Aims 1 and 2). The investigators will also explore whether intervention effects are moderated by dosage, initial language skill, developmental language disorder (DLD) status, word reading skill, nonverbal IQ, and family socioeconomic status (Specific Aim 3). Children who have low language skills and are thus at risk for reading comprehension difficulties will participate in the study. Children will be randomly assigned to receive Let's Know! in small groups at their respective schools or to a business-as-usual control condition. The investigators will measure children's language and comprehension skills at the beginning and end of Grade 1 as well as in Grade 2 and Grade 3. The investigators hypothesize that children who experience Let's Know! will end Grade 1 with higher language skills than children in the control condition and that this will translate into better listening and reading comprehension skills as these children matriculate through elementary school.
Conditions Studied
Interventions
- BEHAVIORAL Let's Know! small-group or TierL 2 Intervention
Study Locations (2)
Massachusetts
- MGH Institute of Health Professions — Boston
Ohio
- The Ohio State University — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05133479
The ClinicalTrials.gov registry entry for NCT05133479 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MGH Institute of Health Professions, which has 40 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Language Disorders in Children appearing as the primary indexed condition, and to 1 intervention — of which Let's Know! small-group or TierL 2 Intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05133479 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05133479 about?
NCT05133479 is a clinical study titled "Let's Know!2: Language-focused Intervention for Children at Risk of Comprehension Difficulties". In the proposed project, the investigators will conduct a multisite randomized controlled trial (RCT) to determine the efficacy of Let's Know!2, a small-group, language focused comprehension intervention, on children's lower- and higher-level language skills and comprehension skills in the short- an...
What is the current status of trial NCT05133479?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 241 participants. The study started on 2021-01-01. Estimated completion is 2026-12-31.
What conditions does trial NCT05133479 study?
This clinical trial studies the following conditions: Language Disorders in Children. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05133479?
The interventions under investigation include: Let's Know! small-group or TierL 2 Intervention (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05133479?
This trial is sponsored by MGH Institute of Health Professions, which has 40 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05133479 being conducted?
This trial has 2 study locations across Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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