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NCT05133479 · ClinicalTrials.gov registry record · NA

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

A NA study of Language Disorders in Children, sponsored by MGH Institute of Health Professions.

Active
Registry status
NA
Development phase
241
Enrollment target
2
Study locations

NCT05133479 is a NA study of Language Disorders in Children that is active but no longer recruiting, run by MGH Institute of Health Professions. The registered enrollment target is 241 participants, above the 31-participant average among 3 other Language Disorders in Children trials with a reported enrollment target (677% higher). The trial reports 2 study locations across 2 states.

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The verdict

NCT05133479, a NA study of Language Disorders in Children, is active but no longer recruiting, sponsored by MGH Institute of Health Professions.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
241 participants
Enrollment target
2
Study locations

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.

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

FieldValue
Enrollment Target 241 participants
Start Date 2021-01-01
Est. Completion 2026-12-31
Phase NA

What the Registry Record Tells You About NCT05133479

The ClinicalTrials.gov registry entry for NCT05133479 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 31-participant average among 3 other Language Disorders in Children trials with a reported enrollment target (677% higher). The listed sponsor is MGH Institute of Health Professions, which has 16 total studies on file at ClinicalTrials.gov.

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.

NCT05133479 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Ohio.

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.

What interventions are being tested in trial NCT05133479?

The interventions under investigation include: Let's Know! small-group or TierL 2 Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT05133479?

This trial is sponsored by MGH Institute of Health Professions, which has 16 total clinical trials registered on ClinicalTrials.gov.

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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