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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 belowSelect...
I can try to repeat 10 words after hearing them.
Select...
Only English is spoken to my child at home.
Select...
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)
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 moreAwards & 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.
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.
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.
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,640 Previous Clinical Trials
957,464 Total Patients Enrolled
University of Illinois at Urbana-ChampaignOTHER
197 Previous Clinical Trials
38,167 Total Patients Enrolled
Vanderbilt UniversityOTHER
710 Previous Clinical Trials
6,143,194 Total Patients Enrolled
1 Trials studying Language Developmental Disorders
97 Patients Enrolled for Language Developmental Disorders
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.Trouble understanding and speaking wordsI have trouble chewing, sucking through a straw, or blowing bubbles.I can try to repeat 10 words after hearing them.You have a neurodevelopmental disability other than DLD, like Down syndrome or autism.Only English is spoken to my child at home.My non-verbal cognitive abilities are normal.
Research Study Groups:
This trial has the following groups:- Group 1: Business-as-usual control
- Group 2: Enhanced Milieu Teaching-Sentence Focus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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