Maximizing Outcomes for Preschoolers With Developmental Language Disorders

Northwestern University

Status and phase: Completed; Phase 2

Conditions: Developmental Language Disorder

Treatments: Behavioral: the Enhanced Milieu Teaching-Sentence Focus

Study type: Interventional

Funder types: Other

Identifiers

NCT03782493

U0046320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 27 to 31 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

Enhanced Milieu Teaching-Sentence Focus

Experimental group

Description:

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.

Treatment:

Behavioral: the Enhanced Milieu Teaching-Sentence Focus

Business-as-usual control

No Intervention group

Description:

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.