Let's Know! Intervention for Childhood Language Disorders

(LK!2 Trial)

Not currently recruiting at 1 trial location

Overseen By Tiffany P Hogan, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: MGH Institute of Health Professions

Disqualifiers: Profound disability, Serious behavior issue, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 22 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program called Let's Know! can enhance language and comprehension skills in young children who struggle with language. The program includes small-group sessions that focus on improving understanding and language use. Researchers will compare children participating in Let's Know! with those receiving regular classroom instruction to assess differences in skill improvement. The trial seeks children in Grade 1 identified as having low language skills and at risk for reading comprehension difficulties. Participants must have basic English proficiency and parental consent to join. As an unphased trial, this study provides a unique opportunity for children to potentially improve their language skills through innovative educational methods.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Let's Know! intervention is safe for children?

Research shows that the Let's Know! program aims to help children improve their language and understanding skills. Studies suggest that similar language programs are usually well-received by young participants. For instance, early research on programs that enhance storytelling skills has shown positive effects on children's language abilities, with no major safety issues reported. This program involves no medication or medical procedures, so the risk of side effects is very low. Children in the Let's Know! program typically engage in organized group activities that are both safe and educational. Overall, the program is considered safe for children and focuses on enhancing their learning experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Let's Know! intervention because it offers a fresh approach to addressing childhood language disorders. Unlike traditional methods that rely solely on typical classroom instruction, this intervention provides targeted support in small-group settings. This personalized attention allows for more tailored language development strategies, which can be more effective in meeting individual needs. With the potential to improve language skills more efficiently, this method holds promise for significantly enhancing communication abilities in children with language disorders.

What evidence suggests that the Let's Know! intervention is effective for childhood language disorders?

Studies have shown that the Let's Know! program can greatly improve language and understanding skills in young children. In this trial, some participants will receive the Let's Know! intervention in small groups. Research indicates that this approach can help children develop better language abilities than those who do not participate in such programs. A study conducted in several states found that this program boosted language and comprehension skills in preschool and kindergarten students. This improvement in language skills is expected to lead to better reading comprehension as children progress in school. The program is especially beneficial for children with low speaking skills, helping them catch up to their classmates. ^{1 2 6 7 8}

Who Is on the Research Team?

Tiffany P Hogan, PhD

Principal Investigator

MGH Institute of Health Professions

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pretest Assessment

Pretest assessments to measure language skills and other abilities before intervention

1-2 weeks

1 visit (in-person)

Treatment

Participants receive the Let's Know! intervention in small groups, focusing on language skills

22 weeks

4 sessions per week

Posttest Assessment

Posttest assessments to measure changes in language and comprehension skills

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for long-term effects on language and comprehension skills

2 years

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• Let's Know! small-group or TierL 2 Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants receive the Let's Know! intervention in small groups as provided by research staff

Group II: Business-As-Usual Active Control 1 Intervention

Participants continue to receive only their typical classroom instruction (i.e., no small groups)

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+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Citations

1. crane.osu.edu crane.osu.edu/our-work/lets-know2/

Let's Know!2 - Crane CenterCrane Center This five-year, NIH-funded project will examine the effect of a specific reading comprehension intervention aimed at helping elementary school students.

2. researchgate.net researchgate.net/publication/359809008_Impacts_of_the_let's_know_Curriculum_on_the_language_and_comprehension-related_skills_of_prekindergarten_and_kindergarten_children

Impacts of the Let's Know! Curriculum on the Language ... We report a multistate experiment of a supplemental, whole-class, language-focused curriculum delivered in prekindergarten and kindergarten classrooms

3. clinicaltrial.be clinicaltrial.be/en/details/36425?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Let's Know!2: Language-focused Intervention for Children... Following pretest assessments and assignment to conditions, research staff will provide the Let's Know! intervention to small groups of 3 to 5 ...

4. withpower.com withpower.com/trial/phase-language-development-disorders-9-2024-bc6ac

Let's Know! for Speech Delay · Info for Participants ', a small-group intervention aimed at improving the spoken language abilities of children with low oral language skills to enhance their reading comprehension.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10734896/

Adapting Curricula for Children With Language ... Delivering Tier 2 small-group instruction affords a targeted focus on those children with low levels of language, many of whom have DLD, who are ...

6. clinconnect.io clinconnect.io/trials/NCT05133479

Let's Know!2: Language-focused Intervention for Children The Let's Know!2 clinical trial is studying a special program designed to help children who struggle with language and may have trouble understanding what they ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26125951/

Tier 2 Language Intervention for Diverse Preschoolers This early-stage study provides evidence that narrative language intervention is an effective approach to improving the language skills of preschoolers with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12032828/

A Cluster Randomized Controlled Trial Comparing the ... This study compares the efficacy of two interventions: Building Early Sentences Therapy (BEST) (McKean et al. 2013) and an adaptation of the ...