Maximizing Outcomes for Preschoolers With Developmental Language Disorders

  • STATUS
    Recruiting
  • End date
    Feb 1, 2024
  • participants needed
    108
  • sponsor
    Northwestern University
Updated on 22 March 2022
Accepts healthy volunteers

Summary

The objective of the proposed study is to evaluate the efficacy of the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention, implemented by caregivers and interventionists, relative to a control condition enrolling 108 30-month-old children and their caregivers. The central hypothesis is that intervention will result in better overall child language skills at 49 months of age.

Description

A multi-site, phase 2, randomized clinical trial will be used to determine whether communication support strategies are effective for improving language outcomes in children with emergent developmental language disorder.

At study entry, 108 children with emergent developmental language disorder (DLD) at 30 months of age will be randomly assigned 1:1 to either the EMT-SF treatment condition or a Business as Usual (BAU) control group. The control group is necessary to determine the efficacy of the EMT-SF intervention. The EMT-SF group is necessary to evaluate the effects of systematically teaching caregivers to use these strategies. Because all children in the study have language delays that will make them eligible to receive the early intervention services through the state early intervention program, children in both experimental conditions will receive state-provided community-based intervention according to their Individualized Family Service Plan - the current standard of care or from private speech language therapy providers. Children in the EMT-SF condition will receive an additional 18 months of interventionist plus caregiver-implemented intervention sessions. Children in both groups will be assessed at the start of the study and every 3 months until the child is 49 months old. The goal is to enroll all children at 30 months of age and provide a minimum of 60 of the planned 66 sessions of intervention to each child in the treatment condition; however, variability in age at study entry (e.g., 30 months), intervention dosage, and number of assessment data points will be addressed in the statistical analysis.

Details
Condition Developmental Language Disorder
Treatment the Enhanced Milieu Teaching-Sentence Focus
Clinical Study IdentifierNCT03782493
SponsorNorthwestern University
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Parent or caregiver (mother, father, grandparent) willing to participate in caregiver training over the full 18 months of the study
Normal non-verbal cognitive abilities
Receptive and expressive language delay
English as the only language spoken to the child in the home
Provision of signed and dated informed consent form
Attempts to imitate 10 words

Exclusion Criteria

Diagnosis of a neurodevelopmental disability other than DLD (e.g., Down syndrome, ASD, intellectual disability)
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 of preterm birth (i.e., < 37 weeks gestation)
Caregiver report of hearing impairment or audiological testing indicating hearing thresholds > 20dB
Caregiver report or direct observation of any problems chewing, sucking through a straw, or blowing bubbles
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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