Let's Know! Intervention for Childhood Language Disorders

(LK!2 Trial)

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

241 Participants Needed

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.

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 data supports the effectiveness of the Let's Know! treatment for childhood language disorders?

The research on direct group therapy, where a speech and language therapist works with a small group of children, shows positive language outcomes for children with language impairments, which suggests that small-group interventions like Let's Know! could be effective. ^{1 2 3 4 5}

How is the Let's Know! treatment for childhood language disorders different from other treatments?

The Let's Know! treatment is unique because it involves a small-group intervention, which may offer more personalized attention compared to traditional large-group or individual therapies. This approach can enhance social interaction and communication skills among children with language disorders. ^{1 5 6 7 8}

Research Team

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.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial and economic evaluation of direct versus indirect and individual versus group modes of speech and language therapy for children with primary language impairment. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Developmental language disorders--a follow-up in later adult life. Cognitive, language and psychosocial outcomes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness of Two Grammar Treatment Procedures for Children With SLI: A Randomized Clinical Trial. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Improving comprehension in adolescents with severe receptive language impairments: a randomized control trial of intervention for coordinating conjunctions. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Screening school-age children for developmental language disorder in primary care. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Follow-up of children at risk for language problems. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Engaging multiple stakeholders to improve speech and language therapy services in schools: an appreciative inquiry-based study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Children with language delay referred to Dutch speech and hearing centres: caseload characteristics. [2021]