Enhanced Language Teaching for Language Disorder

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a special teaching method called Enhanced Milieu Teaching-Sentence Focus (EMT-SF) to help young children with language delays improve their language skills. The study will compare children who receive this new teaching method with those who receive regular community services. Participants should be 30-month-old children with language delays who primarily hear English at home and can attempt to mimic 10 words. Caregivers must be willing to attend training sessions over 18 months. The researchers hope that children using EMT-SF will have better language skills by age 49 months.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the EMT-SF intervention is safe for children with language disorders?

Research has shown that Enhanced Milieu Teaching-Sentence Focus (EMT-SF) is a safe method for helping children with language disorders. Studies have found that EMT naturally improves language skills. Past studies have reported no major negative effects from EMT-SF, indicating that children generally handle it well. EMT-SF is a behavioral approach, teaching caregivers how to support their child's language development through direct interaction and communication, not medication. This reduces the risk of side effects often associated with drug treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) because it offers a fresh approach to treating language disorders by directly engaging caregivers in the intervention process. Unlike traditional therapies that might rely solely on professional sessions, EMT-SF empowers parents and caregivers with specific strategies to enhance vocabulary and grammar, which they can use in daily interactions with the child. This method not only focuses on immediate language development but also supports the transition to more complex language use, potentially leading to lasting improvements in communication skills.

What evidence suggests that EMT-SF is effective for language disorder?

Studies have shown that Enhanced Milieu Teaching-Sentence Focus (EMT-SF), which participants in this trial may receive, effectively improves language skills in young children. Research indicates that when parents and therapists use EMT strategies together, children develop better vocabulary and grammar. This method teaches caregivers to support language growth in everyday situations. Early findings suggest that children in EMT-SF programs make significant progress in using language beyond their immediate surroundings. These results make EMT-SF a promising option for helping children with language disorders enhance their language skills. ^{1 3 4 5 6}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03782493

Study Details | NCT03782493 | Maximizing Outcomes for ... The objective of the proposed study is to evaluate the efficacy of the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention, implemented by ...

2. vanderbilt.trialstoday.org vanderbilt.trialstoday.org/trial/NCT03782493

Vanderbilt Clinical Trials The objective of the proposed study is to evaluate the efficacy of the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3740334/

Parent-Implemented Enhanced Milieu Teaching with ... The purpose of this study was to compare the effects of Enhanced Milieu Teaching (EMT) implemented by parents and therapists versus therapists only on the ...

4. ctv.veeva.com ctv.veeva.com/study/maximizing-outcomes-for-preschoolers-with-developmental-language-disorders

Maximizing Outcomes for Preschoolers With Developmental ... The objective of the proposed study is to evaluate the efficacy of the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention, ...

5. ies.ed.gov ies.ed.gov/use-work/awards/efficacy-trial-j-emt-enhanced-milieu-teaching-language-intervention-plus-joint-attention-engagement

An Efficacy Trial of J-EMT: Enhanced Milieu Teaching ... This project will evaluate the efficacy of an early social communication and language intervention, the J-EMT, on toddlers with autism spectrum disorders (ASD).

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39666897/

Systematic Review and Meta-Analysis of Enhanced Milieu ... Enhanced milieu teaching (EMT) is a naturalistic intervention that supports the language development of children with emerging language.