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Let's Know! Intervention for Childhood Language Disorders (LK!2 Trial)

N/A
Recruiting
Led By Tiffany P Hogan, PhD
Research Sponsored by MGH Institute of Health Professions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
Profound disability that severely impairs classroom participation, as reported by teachers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after intervention ends
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the efficacy of Let's Know!, 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.

Who is the study for?
This trial is for Grade 1 children with low language skills, at risk of comprehension difficulties. They must have parental consent, score below a specific language screener threshold, and possess basic English proficiency. Children with profound disabilities or serious behavior issues affecting classroom participation are excluded.
What is being tested?
The 'Let's Know!2' intervention is being tested to improve language and reading comprehension in young children. This study randomly assigns kids to either the Let's Know! program or regular school activities and tracks their progress from Grade 1 through Grade 3.
What are the potential side effects?
Since this trial involves educational interventions rather than medical treatments, traditional side effects are not applicable. However, there may be variations in individual experiences based on the child’s engagement and response to the intervention.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My disability significantly affects my ability to participate in class.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after intervention ends
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after intervention ends for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in a child's ability to comprehend short passages read aloud to them, as assessed by the LARRC Listening Comprehension Measure
Change in a child's ability to comprehend short passages they read, as assessed by the LARRC Reading Comprehension Measure
Change in ability to understand stories, as assessed by the Test of Narrative Language
+18 more
Other study objectives
Academic performance will be assessed by the Massachusetts or Ohio State Assessments of Reading
Change in timed word and nonword reading, as assessed by the Test of Word Reading Efficiency - Second Edition
Language comprehension skills, as assessed by the OWL Language Screener
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants receive the Let's Know! intervention in small groups as provided by research staff
Group II: Business-As-UsualActive Control1 Intervention
Participants continue to receive only their typical classroom instruction (i.e., no small groups)

Find a Location

Who is running the clinical trial?

University of KansasOTHER
153 Previous Clinical Trials
331,287 Total Patients Enrolled
Ohio State UniversityOTHER
866 Previous Clinical Trials
654,644 Total Patients Enrolled
MGH Institute of Health ProfessionsLead Sponsor
16 Previous Clinical Trials
3,188 Total Patients Enrolled

Media Library

Let's Know! small-group or TierL 2 Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05133479 — N/A
Childhood Language Disorders Research Study Groups: Intervention, Business-As-Usual
Childhood Language Disorders Clinical Trial 2023: Let's Know! small-group or TierL 2 Intervention Highlights & Side Effects. Trial Name: NCT05133479 — N/A
Let's Know! small-group or TierL 2 Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05133479 — N/A
~106 spots leftby Dec 2025
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