Enhanced Language Teaching for Language Disorder

Recruiting at 1 trial location

Overseen By Megan Y Roberts, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Disqualifiers: Down syndrome, ASD, intellectual disability, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 69

Duration: 18 months

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a teaching method called EMT-SF, where caregivers help young children with language delays improve their speaking skills. The study focuses on young children with early signs of language problems. By training caregivers to use special communication techniques, the goal is to see if these children can develop better language abilities as they grow older. Enhanced Milieu Teaching (EMT) has been used in various studies to improve language skills in children with language impairments.

Who Is on the Research Team?

Megan Y Roberts, PhD

Principal Investigator

Northwestern University

Ann Kaiser, PhD

Principal Investigator

Vanderbilt University

Pamela Hadley, PhD

Principal Investigator

University of Illinois at Urbana-Champaign

Are You a Good Fit for This Trial?

This trial is for 30-month-old children with language delays who can try to imitate 10 words and have normal non-verbal cognitive abilities. Caregivers must be willing to participate in training throughout the study. The child should only be exposed to English at home, and not have any major medical conditions or disabilities other than Developmental Language Disorder.

Inclusion Criteria

Trouble understanding and speaking words

Parent or caregiver (mother, father, grandparent) willing to participate in caregiver training over the full 18 months of the study

I can try to repeat 10 words after hearing them.

Exclusion Criteria

My caregiver reports I have a major medical condition like cancer or epilepsy.

The caregiver has reported that the baby was born before 37 weeks of pregnancy.

The caregiver reports hearing problems or the results of a hearing test show hearing loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children receive the EMT-SF intervention or participate in the Business-as-usual control group for 18 months

18 months

66 intervention sessions

Follow-up

Participants are monitored for language development and outcomes every 3 months until 49 months of age

19 months

Regular assessments every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• EMT-SF

Trial Overview The trial tests Enhanced Milieu Teaching-Sentence Focus (EMT-SF), an intervention by caregivers aimed at improving language skills of preschoolers with developmental language disorders by the time they reach 49 months old, compared to a control condition.

How Is the Trial Designed?

Group I: Enhanced Milieu Teaching-Sentence Focus Experimental Treatment 1 Intervention

The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.

Group II: Business-as-usual control Active Control 1 Intervention

Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Illinois at Urbana-Champaign

Collaborator

Trials

203

Recruited

40,600+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+