Maximizing Outcomes for Preschoolers With Developmental Language Disorders

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 48 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.

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.