~33 spots leftby Dec 2025

Let's Know! Intervention for Childhood Language Disorders

(LK!2 Trial)

Recruiting in Palo Alto (17 mi)
+1 other location
TP
Overseen byTiffany P Hogan, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: MGH Institute of Health Professions
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

TP

Tiffany P Hogan, PhD

Principal Investigator

MGH Institute of Health Professions

Eligibility Criteria

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.

Inclusion Criteria

Basic English proficiency as reported by parents/teachers
You have scores lower than what is required on the OWL Language Screener.
I am in the first grade of the study.
See 1 more

Exclusion Criteria

You have a significant behavior problem that makes it hard for you to take part in class, according to what your teachers have said.
My disability significantly affects my ability to participate in class.
Unable to speak or understand English at a basic level, as reported by parents/teachers

Treatment Details

Interventions

  • Let's Know! small-group or TierL 2 Intervention (Behavioural Intervention)
Trial OverviewThe '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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

MGH Institute of Health Professions

Lead Sponsor

Trials
19
Recruited
2,200+

University of Kansas

Collaborator

Trials
157
Recruited
332,000+
Lynne A. Bui profile image

Lynne A. Bui

University of Kansas

Chief Medical Officer since 2017

MD from the David Geffen UCLA School of Medicine, BA in Molecular and Cell Biology from University of California, Berkeley

Randy Milby

University of Kansas

Chief Executive Officer since 2017

BS in Pharmacy from The University of Kansas, MBA in Finance/Marketing from Washington University in St. Louis – Olin Business School

Ohio State University

Collaborator

Trials
891
Recruited
2,659,000+
Dr. John J. Warner profile image

Dr. John J. Warner

Ohio State University

Chief Executive Officer since 2023

MD, MBA

Dr. Peter Mohler profile image

Dr. Peter Mohler

Ohio State University

Chief Medical Officer since 2023

PhD in Molecular Biology

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+
Joshua M. Levy profile image

Joshua M. Levy

National Institute on Deafness and Other Communication Disorders (NIDCD)

Chief Medical Officer

MD, MPH, MS

Debara L. Tucci profile image

Debara L. Tucci

National Institute on Deafness and Other Communication Disorders (NIDCD)

Chief Executive Officer since 2019

MD, MS, MBA