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

Study acronym: LK!2
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints: details revised at 4 of 21 entries Show 5 more changesShow less
    • Study completion pushed from Dec 31, 2026 to Dec 31, 2027
    • Interventions: Let's Know! small-group or TierL 2 Intervention (Behavioral) to Let's Know! small-group or TierL 2 Intervention (Behavioral)
    • Eligibility criteria expanded, about 7 words
    • Study description revised
    • Publications: details revised at 67 of 75 entries
  2. Primary completion date: Dec 31, 2025 to Jun 30, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Eligibility criteria expanded, about 4 words
    v5
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 480 to confirmed 241
    • Site details revised at 2 of 2 sites
    v4
  4. Study description expanded, about 21 wordsv3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Language Disorders in Children
Related terms Dyslexia, Specific Language Disorder
Enrollment 241 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov