What is the mechanism of action of this treatment?

Enhanced Milieu Teaching-Sentence Focus (EMT-SF) and similar interventions work by integrating naturalistic teaching strategies with a focus on sentence production, often involving both caregivers and interventionists. These treatments use modeling, prompting, and reinforcement within the child's daily environment to encourage the use of complex sentences and improve overall language skills. This approach is crucial for patients with language developmental disorders as it leverages familiar contexts and consistent practice, which can lead to more meaningful and sustained language improvements. By involving caregivers, these interventions also ensure that language development support is continuous and embedded in the child's everyday interactions.

What side effects are associated with this type of intervention?

Common treatments for Language Developmental Disorders, such as Enhanced Milieu Teaching-Sentence Focus (EMT-SF), typically involve intensive language intervention strategies implemented by caregivers and interventionists. These treatments are generally well-tolerated and do not have significant medical side effects. However, potential challenges include caregiver stress due to the time and effort required for consistent implementation, and possible frustration or resistance from the child during therapy sessions. Ensuring adequate training and support for caregivers can help mitigate these issues.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Language Developmental Disorders. Treatments like Enhanced Milieu Teaching-Sentence Focus (EMT-SF) focus on behavioral and educational interventions rather than pharmacological approaches. These interventions involve caregivers and therapists working together to improve language skills in children through structured and naturalistic communication opportunities.

What other types of research exist?

Promising novel alternatives to Enhanced Milieu Teaching-Sentence Focus (EMT-SF) for language developmental disorders include: 1) The Hanen Program, which emphasizes parent training to promote language development through everyday interactions. 2) The Picture Exchange Communication System (PECS), which uses pictures to help children develop communication skills. 3) The DIR/Floortime model, which focuses on emotional and relational development as a foundation for language skills. 4) The Social Communication, Emotional Regulation, and Transactional Support (SCERTS) model, which integrates approaches to support social communication and emotional regulation. These interventions have shown positive outcomes in recent studies and are considered effective for language development.

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Behavioral Intervention

Enhanced Language Teaching for Language Disorder

Phase 2

Waitlist Available

Led By Ann Kaiser, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Attempts to imitate 10 words

English as the only language spoken to the child in the home

Must not have

Caregiver report of a major medical condition (e.g., seizures, cancer, stroke, traumatic head injury, cleft lip/palate, cerebral palsy, legally blind, any genetic diagnosis associated)

Caregiver report or direct observation of any problems chewing, sucking through a straw, or blowing bubbles

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between 30 to 49 months (measured every 3 months)

Awards & highlights

No Placebo-Only Group

Summary

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 the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves educational and behavioral interventions rather than medications, there are no typical 'side effects' like you'd expect from drugs. However, participants may experience varying levels of engagement or stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can try to repeat 10 words after hearing them.

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Only English is spoken to my child at home.

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My non-verbal cognitive abilities are normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have trouble chewing, sucking through a straw, or blowing bubbles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between 30 to 49 months (measured every 3 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between 30 to 49 months (measured every 3 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between 30 to 49 months (measured every 3 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in a latent factor of grammar from a Language Sample

Change in number of different spoken words from a Language Sample

Clinical Evaluation of Language Fundamentals Preschool - 2nd edition (CELF-P2)

Secondary study objectives

Child Behavior Checklist (CBCL)

Decontextualized language from a Language Sample

Expressive Vocabulary Test - 3rd edition (EVT-3)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced Milieu Teaching-Sentence FocusExperimental Treatment1 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 controlActive Control1 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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Enhanced Milieu Teaching-Sentence Focus (EMT-SF) and similar interventions work by integrating naturalistic teaching strategies with a focus on sentence production, often involving both caregivers and interventionists. These treatments use modeling, prompting, and reinforcement within the child's daily environment to encourage the use of complex sentences and improve overall language skills. This approach is crucial for patients with language developmental disorders as it leverages familiar contexts and consistent practice, which can lead to more meaningful and sustained language improvements. By involving caregivers, these interventions also ensure that language development support is continuous and embedded in the child's everyday interactions.

Targeting Complex Sentences in Older School Children With Specific Language Impairment: Results From an Early-Phase Treatment Study.Longitudinal Effects of Adaptive Interventions With a Speech-Generating Device in Minimally Verbal Children With ASD.A Comparison of High and Low Dosages of a Component of Milieu Teaching Strategies for Two Preschool-Age Learners With Autism Spectrum Disorder.