Clinical trial NCT03782493: Maximizing Outcomes for Preschoolers With Developmental Language Disorders
Official title: Maximizing Outcomes for Preschoolers With Developmental Language Disorder: Testing the Effects of a Sequentially Targeted Naturalistic Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Developmental Language Disorder
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
name: University of Illinois at Urbana-Champaign
First posted: 2018-12-20
Enrollment: 108
Sex: ALL
Minimum age (years): 27
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A stratified randomized clinical trial design will be used with site (Vanderbilt, Northwestern) and biological sex (boys, girls) as stratification factors and EMT-SF or business-as-usual (BAU) control as a randomization factor.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Evaluation of Language Fundamentals Preschool - 2nd edition (CELF-P2)
timeFrame: 49 months
measure: Change in number of different spoken words from a Language Sample
timeFrame: Change between 30 to 49 months (measured every 3 months)
measure: Change in a latent factor of grammar from a Language Sample
timeFrame: Change between 30 to 49 months (measured every 3 months)
Secondary outcomes:
measure: Peabody Picture Vocabulary Test - 5th Edition (PPVT-5)
timeFrame: 36 months
measure: Expressive Vocabulary Test - 3rd edition (EVT-3)
timeFrame: 36 months
measure: Structured Photographic Expressive Language Test - Preschool 2nd edition (SPELT-P2)
timeFrame: 42 months
measure: Structured Photographic Expressive Language Test - Preschool 2nd edition (SPELT-P2)
timeFrame: 49 months
measure: Test of Early Grammatical Impairment - 3rd person singular & past tense probes (TEGI)
timeFrame: 42 months
measure: Test of Early Grammatical Impairment - 3rd person singular & past tense probes (TEGI)
timeFrame: 49 months
measure: Focus on the Outcomes of Children Under Six (FOCUS)
timeFrame: 49 months
measure: Decontextualized language from a Language Sample
timeFrame: 49 months
measure: Renfrew Bus Story - North American Edition (RBS-NA)
timeFrame: 49 months
measure: Child Behavior Checklist (CBCL)
timeFrame: 49 months
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Northwestern University
name: Megan Y Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Urbana-Champaign
name: Pamela Hadley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Ann Kaiser, PhD
role: PRINCIPAL_INVESTIGATOR
References: