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Behavioral Intervention

Enhanced Language Teaching for Language Disorder

Phase 2
Waitlist Available
Led By Megan Y Roberts, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between 30 to 49 months (measured every 3 months)
Awards & highlights

Study Summary

This trial will test whether a new intervention can help improve language skills in young children.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Child Behavior Checklist (CBCL)
Decontextualized language from a Language Sample
Expressive Vocabulary Test - 3rd edition (EVT-3)
+5 more

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.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,123 Total Patients Enrolled
University of Illinois at Urbana-ChampaignOTHER
188 Previous Clinical Trials
37,227 Total Patients Enrolled
Vanderbilt UniversityOTHER
703 Previous Clinical Trials
6,143,239 Total Patients Enrolled
1 Trials studying Language Developmental Disorders
97 Patients Enrolled for Language Developmental Disorders

Media Library

EMT-SF (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03782493 — Phase 2
Language Developmental Disorders Research Study Groups: Business-as-usual control, Enhanced Milieu Teaching-Sentence Focus
Language Developmental Disorders Clinical Trial 2023: EMT-SF Highlights & Side Effects. Trial Name: NCT03782493 — Phase 2
EMT-SF (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03782493 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any age restrictions for participation in this research?

"Aspiring participants of this medical experiment must be between 27 and 31 months in age."

Answered by AI

How many volunteers are actively participating in this research project?

"That is correct. The details posted on clinicaltrials.gov confirm that the trial, which was initially published in April 2019, is actively looking for 108 participants to be enrolled from two medical sites."

Answered by AI

Are there current openings for individuals to participate in this experiment?

"Clinicaltrials.gov reveals that this clinical trial, initially posted on April 4th 2019, is currently recruiting participants and was last updated on January 4th 2022."

Answered by AI

Who meets the eligibility requirements to take part in this medical experiment?

"This trial seeks 108 children between 27-31 Months of age who present with language development disorders. The other eligibility criteria include: Parent/caregiver commitment to 18 months of caregiver training, normal non-verbal cognitive capabilities, native English speaker in the child's home environment, informed consent signing and dated form completion, and attempts to imitate 10 words or more."

Answered by AI

Has the Enhanced Milieu Teaching-Sentence Focus attained regulatory affirmation from the FDA?

"The Enhanced Milieu Teaching-Sentence Focus has been assigned a safety rating of 2 due to its Phase 2 status, which indicates that preliminary data shows some degree of protection but efficacy has yet to be established."

Answered by AI

What are the key aims of this medical trial?

"This trial will evaluate outcomes over a 30 to 49 month period, with measurements taken every 3 months. The primary outcome measure is Clinical Evaluation of Language Fundamentals Preschool - 2nd edition (CELF-P2) whereas secondary measures include Test of Early Grammatical Impairment - 3rd person singular & past tense probes (TEGI), Peabody Picture Vocabulary Test - 5th Edition (PPVT-5), and Child Behavior Checklist Internalizing T score (CBCL). For the TEGI subscales, higher scores represent more positive results while lower CBCL values suggest better findings."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Maximizing Outcomes for Preschoolers With Developmental Language Disorders
Megan Roberts 2019. "Maximizing Outcomes for Preschoolers With Developmental Language Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03782493.
~14 spots leftby Jan 2025
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