Clinical Trial

Let's Know!2: Language-focused Intervention for Children at Risk of Comprehension Difficulties

Study acronym: LK!2
Active, Not Recruiting
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Record status
This record was last updated December 24, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-11-12; most recent amendment 2025-12-23.
Status change: Recruiting → Active, Not Recruiting 2024-12-16
Trial Details
NCT Number NCT05133479
Lead Sponsor MGH Institute of Health Professions
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), Ohio State University, University of Kansas
Conditions Language Disorders in Children
Enrollment 241 participants
Start Date 2021-01-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-24